PRINCETON, N.J. & LONDON--23th July--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30th and validation of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for ONGLYZA™ (saxagliptin). Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, is an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. The companies have proposed the name ONGLYZA which, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin.
The NDA and MAA submissions for saxagliptin are based on data from a comprehensive clinical trial program conducted in addition to standard therapies, as well as in treatment naïve patients as a monotherapy. The clinical trial program included studies that evaluated the drug at up to 80 times therapeutic clinical doses. The six core Phase III trials assessing the safety and efficacy of saxagliptin involved more than 4,000 patients, including 3,000 who were treated with saxagliptin.
About ONGLYZA
ONGLYZA, a DPP-4 inhibitor, is an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. Saxagliptin is being studied in clinical trials as a once-daily therapy to determine its efficacy and safety. Saxagliptin was specifically designed to be a selective, reversible inhibitor of the DPP-4 enzyme, with dual routes of clearance. Phase III data for saxagliptin have previously been presented in combination with metformin, the most commonly prescribed oral anti-diabetic, as well as when used as monotherapy in treatment-naïve individuals. Additional Phase III data for saxagliptin, including when added to a sulfonylurea, a thiazolidinedione and as initial combination therapy with metformin, are planned for disclosure later this year.
About DPP-4 Inhibitors
DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease elevated blood sugar levels (glucose) by increasing the body’s utilization of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver’s production of glucose.
About Type 2 Diabetes
Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches (carbohydrates) and other nutrients into energy needed for daily life. The cause of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role. Diabetes is associated with long-term complications that affect almost every part of the body. The disease may lead to blindness, heart and blood vessel disease, stroke, kidney failure, amputations, and nerve damage.
Bristol-Myers Squibb and AstraZeneca Collaboration
Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize two investigational drugs for type 2 diabetes – saxagliptin and dapagliflozin. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit www.bms.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com
ONGLYZA™ (saxagliptin) is a trademark of the Bristol-Myers Squibb Company
Contacts
Media:
Bristol-Myers Squibb
David M. Rosen, 609-252-5675
david.rosen@bms.com
or
AstraZeneca
Jim Minnick, 302-866-5135
jim.minnick@astrazeneca.com
or
Investors:
Bristol-Myers Squibb
John Elicker, 212-546-3775
john.elicker@bms.com
or
AstraZeneca
Mina Blair, 44-20-7304-5084
mina.blair@astrazeneca.com
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7/30/2008
HealthMedia Launches First-Ever Binge Eating Campaign and Intervention to Take on Nation's Top Eating Disorder
Web-Based Program Fills Large Industry Gap in Obesity and Weight Management Treatment
ANN ARBOR, Mich., July 21 /PRNewswire/ -- HealthMedia, Inc., the
pioneer in applying advanced technology to emulate a health coaching
session via the web - without the coach - for wellness, disease management,
behavioral health, and medication adherence, is launching HealthMedia(R)
Overcoming(TM) Binge Eating. This revolutionary new program is the first
solution of its kind that addresses America's top eating disorder and its
growing impact on healthcare costs and productivity. The highly effective,
evidence-based program emulates the experience of an around-the-clock
health coach, nutritionist, and psychologist working together via the web
to help individuals suffering from Binge Eating Disorder (BED) regain
control of their eating and emotions.
Just as a psychologist would do, Overcoming Binge Eating connects with
each individual, and gathers detailed information such as distinct eating
triggers, motivation, self confidence, stage of change, and barriers to
change. Then, using HealthMedia's Fusion(TM) technology, Overcoming Binge
Eating creates a personalized, highly tailored program to help individuals
control their eating and enjoy a higher quality of life.
An untailored version of the program is being used successfully by
treatment centers and individuals throughout the world, and has been proven
to reduce frequency of compulsive overeating by 40 percent, and
significantly reduce symptoms of depression and anxiety. Highmark Inc. and
other health plans and employers are recognizing and responding to the need
to address binge eating, and are offering the newly enhanced and tailored
binge eating program to their members and employees over the next few
months.
"Highmark has long been at the forefront of leading initiatives aimed
at fighting obesity in children and adults. We are very pleased that
HealthMedia has developed an online program to address binge eating," said
Donald R. Fischer, MD, senior vice president and chief medical officer at
Highmark Inc. "Because of the secrecy associated with this disorder,
individuals often do not readily seek treatment. The confidential,
non-threatening approach of Overcoming Binge Eating makes this online tool
a valuable addition to the treatment of this complex problem. Highmark
plans to offer this program to our employees and members."
"Like insomnia, binge eating is one of those issues that affect
productivity and a range of medical outcomes, particularly when binge
eating is co-morbid with chronic conditions such as diabetes and heart
disease," said Ted Dacko, HealthMedia President and CEO. "Binge eating
interventions fill a critical gap in health and wellness, disease
management, and behavioral health, and should be an integral part of any
weight management or obesity program."
"Researchers now believe that like other eating disorders, there are
psychiatric reasons for binge eating and it all feeds into an obesity
epidemic that seems to start in childhood," said NBC reporter Tom Costello,
on a recent episode of the Today show. The effects and severity of BED were
also echoed by Costello in a recent NBC News segment
(http://video.msn.com/video.aspx?mkt=en-us&vid=d97b6451-60f5-41db-be4f-
e8cf48cd343f). (Due to the length of the URL, please copy and paste into
your browser.)
This program is just one part of HealthMedia's national campaign to
call attention to binge eating. In the U.S. alone, BED is estimated to be
responsible for $33 million in lost productivity and medical expenses
annually. The Centers for Disease Control and Prevention reported last week
that more than a quarter of Americans are now obese - up nearly two percent
between 2005 and 2007. Up to 25% of obese individuals suffer from Binge
Eating Disorder. "Most organizations have a weight management program, but
they are missing the binge eating component, which is why we built this
program," added Dacko. "By adding this revolutionary product to the
MyHealthMedia suite, we are filling an enormous gap in the marketplace."
"Binge eating disorder - often a secretive illness - frequently goes
undiagnosed so it is hard to get a true picture of how many people suffer,"
said Lynn Grefe, CEO, National Eating Disorder Association. "All reports
indicate it affects many millions. The medical and psychological
consequences can be devastating, whether associated with bulimia or
obesity. As with all eating disorders, early intervention is vital to
successful recovery."
Binge Eating Facts:
-- Binge eating now tops the nation's list of eating disorders - more
prevalent than anorexia and bulimia combined
-- BED sufferers repeatedly consume large amounts of food at one
sitting (more than 1,500 calories), and often eat to cope with stress or
numb themselves from depression or past traumas
-- According to a recent study, 3.5% of females and 2% of males (over 6
million Americans) suffer from binge eating
-- Up to 25% of obese individuals suffer from BED, a fact that assumes
even greater importance as the national rate of obesity is peaking at an
all-time high. Obesity is the second cause of preventable deaths in the
U.S. and over 25 percent or 50 million Americans are considered obese
-- Most binge eaters are desperate for help, but stigma and
embarrassment often prevent them from seeking treatment
-- While treatments such as cognitive-behavioral therapy (CBT) can be
effective for binge eaters, too many go undiagnosed and too few know where
to go for help
-- Many binge eaters have reported that diet and weight loss treatment
programs recommended by their doctor not only ignored the psychological and
emotional elements, but in many cases caused their BED to escalate
About HealthMedia, Inc.
HealthMedia, Inc. is the world's innovator in combining advanced
technology and behavioral science to effectively emulate a health coach via
the web. HealthMedia applies its revolutionary Fusion(TM) technology to
address the five most problematic pain points facing the health industry
today: participation, scalability, cost, efficacy, and return on
investment. HealthMedia's suite of interventions provides automated
web-based coaching for wellness, disease management, behavioral health, and
medication adherence with proven outcomes, increased compliance, reduced
medical utilization, and increased productivity - boosting profitability
for health plans, employers, pharmaceutical companies, and behavioral
health organizations. Clients include Kaiser Permanente, Johnson & Johnson,
Daiichi Sankyo, Fresh & Easy Neighborhood Market, Inc., Community First
Health Plans, and nine Blue Cross Blue Shield organizations across the
United States. HealthMedia partners include APS Healthcare, Corphealth,
Health Dialog, Wellsource, and SHPS. For more information, visit
http://www.healthmedia.com .
ANN ARBOR, Mich., July 21 /PRNewswire/ -- HealthMedia, Inc., the
pioneer in applying advanced technology to emulate a health coaching
session via the web - without the coach - for wellness, disease management,
behavioral health, and medication adherence, is launching HealthMedia(R)
Overcoming(TM) Binge Eating. This revolutionary new program is the first
solution of its kind that addresses America's top eating disorder and its
growing impact on healthcare costs and productivity. The highly effective,
evidence-based program emulates the experience of an around-the-clock
health coach, nutritionist, and psychologist working together via the web
to help individuals suffering from Binge Eating Disorder (BED) regain
control of their eating and emotions.
Just as a psychologist would do, Overcoming Binge Eating connects with
each individual, and gathers detailed information such as distinct eating
triggers, motivation, self confidence, stage of change, and barriers to
change. Then, using HealthMedia's Fusion(TM) technology, Overcoming Binge
Eating creates a personalized, highly tailored program to help individuals
control their eating and enjoy a higher quality of life.
An untailored version of the program is being used successfully by
treatment centers and individuals throughout the world, and has been proven
to reduce frequency of compulsive overeating by 40 percent, and
significantly reduce symptoms of depression and anxiety. Highmark Inc. and
other health plans and employers are recognizing and responding to the need
to address binge eating, and are offering the newly enhanced and tailored
binge eating program to their members and employees over the next few
months.
"Highmark has long been at the forefront of leading initiatives aimed
at fighting obesity in children and adults. We are very pleased that
HealthMedia has developed an online program to address binge eating," said
Donald R. Fischer, MD, senior vice president and chief medical officer at
Highmark Inc. "Because of the secrecy associated with this disorder,
individuals often do not readily seek treatment. The confidential,
non-threatening approach of Overcoming Binge Eating makes this online tool
a valuable addition to the treatment of this complex problem. Highmark
plans to offer this program to our employees and members."
"Like insomnia, binge eating is one of those issues that affect
productivity and a range of medical outcomes, particularly when binge
eating is co-morbid with chronic conditions such as diabetes and heart
disease," said Ted Dacko, HealthMedia President and CEO. "Binge eating
interventions fill a critical gap in health and wellness, disease
management, and behavioral health, and should be an integral part of any
weight management or obesity program."
"Researchers now believe that like other eating disorders, there are
psychiatric reasons for binge eating and it all feeds into an obesity
epidemic that seems to start in childhood," said NBC reporter Tom Costello,
on a recent episode of the Today show. The effects and severity of BED were
also echoed by Costello in a recent NBC News segment
(http://video.msn.com/video.aspx?mkt=en-us&vid=d97b6451-60f5-41db-be4f-
e8cf48cd343f). (Due to the length of the URL, please copy and paste into
your browser.)
This program is just one part of HealthMedia's national campaign to
call attention to binge eating. In the U.S. alone, BED is estimated to be
responsible for $33 million in lost productivity and medical expenses
annually. The Centers for Disease Control and Prevention reported last week
that more than a quarter of Americans are now obese - up nearly two percent
between 2005 and 2007. Up to 25% of obese individuals suffer from Binge
Eating Disorder. "Most organizations have a weight management program, but
they are missing the binge eating component, which is why we built this
program," added Dacko. "By adding this revolutionary product to the
MyHealthMedia suite, we are filling an enormous gap in the marketplace."
"Binge eating disorder - often a secretive illness - frequently goes
undiagnosed so it is hard to get a true picture of how many people suffer,"
said Lynn Grefe, CEO, National Eating Disorder Association. "All reports
indicate it affects many millions. The medical and psychological
consequences can be devastating, whether associated with bulimia or
obesity. As with all eating disorders, early intervention is vital to
successful recovery."
Binge Eating Facts:
-- Binge eating now tops the nation's list of eating disorders - more
prevalent than anorexia and bulimia combined
-- BED sufferers repeatedly consume large amounts of food at one
sitting (more than 1,500 calories), and often eat to cope with stress or
numb themselves from depression or past traumas
-- According to a recent study, 3.5% of females and 2% of males (over 6
million Americans) suffer from binge eating
-- Up to 25% of obese individuals suffer from BED, a fact that assumes
even greater importance as the national rate of obesity is peaking at an
all-time high. Obesity is the second cause of preventable deaths in the
U.S. and over 25 percent or 50 million Americans are considered obese
-- Most binge eaters are desperate for help, but stigma and
embarrassment often prevent them from seeking treatment
-- While treatments such as cognitive-behavioral therapy (CBT) can be
effective for binge eaters, too many go undiagnosed and too few know where
to go for help
-- Many binge eaters have reported that diet and weight loss treatment
programs recommended by their doctor not only ignored the psychological and
emotional elements, but in many cases caused their BED to escalate
About HealthMedia, Inc.
HealthMedia, Inc. is the world's innovator in combining advanced
technology and behavioral science to effectively emulate a health coach via
the web. HealthMedia applies its revolutionary Fusion(TM) technology to
address the five most problematic pain points facing the health industry
today: participation, scalability, cost, efficacy, and return on
investment. HealthMedia's suite of interventions provides automated
web-based coaching for wellness, disease management, behavioral health, and
medication adherence with proven outcomes, increased compliance, reduced
medical utilization, and increased productivity - boosting profitability
for health plans, employers, pharmaceutical companies, and behavioral
health organizations. Clients include Kaiser Permanente, Johnson & Johnson,
Daiichi Sankyo, Fresh & Easy Neighborhood Market, Inc., Community First
Health Plans, and nine Blue Cross Blue Shield organizations across the
United States. HealthMedia partners include APS Healthcare, Corphealth,
Health Dialog, Wellsource, and SHPS. For more information, visit
http://www.healthmedia.com .
FDA Updates Label for AVANDIA(R) to Include Clinical Findings Demonstrating Sustained Glycemic Control for Up to Five Years
Data Provides Further Information on AVANDIA as a Safe and Effective
Treatment Option for Appropriate Type 2 Diabetes Patients
PHILADELPHIA, July 14 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:
GSK) announces today that the U.S. Food and Drug Administration (FDA)
updated the prescribing information for AVANDIA(R) (rosiglitazone maleate)
to include clinical findings from A Diabetes Outcome Progression Trial
(ADOPT), a 4- to- 6 year head-to-head study of AVANDIA versus metformin and
glyburide monotherapy in recently diagnosed type 2 diabetes patients. The
percentage of patients with inadequate glucose control at five years was 34
percent with glyburide, 21 percent with metformin and only 15 percent with
AVANDIA. The difference between AVANDIA and the comparators was
statistically significant.
"GSK is pleased that the FDA has approved inclusion of the results from
ADOPT, an important clinical trial that provides substantial long-term
efficacy and safety data on AVANDIA compared to metformin and
sulfonylurea," said Alexander R. Cobitz, MD, PhD, Senior Director,
Metabolism, Clinical Development and Medical Affairs, GlaxoSmithKline. "As
demonstrated in this study, patients treated with AVANDIA achieved greater
sustained glycemic control. Better glycemic control has been proven to
reduce risks of serious complications associated with type 2 diabetes
including blindness, loss of limbs and kidney failure."
Study Design
ADOPT was a large, international, multi-center, randomized,
double-blind, parallel-group study involving 4,351 people, aged 30-75 years
who were recently diagnosed with type 2 diabetes (less than or equal to 3
years) from more than 400 sites throughout North America and Europe. ADOPT,
conducted over a period of 4 to 6 years, assessed the cumulative incidence
of monotherapy failure at five years with AVANDIA, metformin, glyburide, as
defined by consecutive fasting plasma glucose (FPG) >180 mg/dL.
Patients were randomized to receive either AVANDIA 4 mg once daily,
glyburide 2.5 mg once daily, or metformin 500 mg once daily, and doses were
titrated to optimal glycemic control up to a maximum of 4 mg twice daily
for AVANDIA, 7.5 mg twice daily for glyburide, and 1,000 mg twice daily for
metformin. Initial treatment with AVANDIA reduced the risk of monotherapy
failure in people with type 2 diabetes by 32 percent compared to metformin
(p<0.001), and 63 percent compared to glyburide (p<0.001) at five years.
Safety Information from ADOPT
In ADOPT, AVANDIA was reported to be generally well-tolerated among the
large cohort of people with type 2 diabetes who were followed for up to six
years. Incidence of congestive heart failure (CHF) adverse events was the
same among patients treated with AVANDIA (0.8 percent) and metformin (0.8
percent); however, people given glyburide experienced a lower rate of CHF
events (0.2 percent).
Over the duration of the study, commonly reported adverse events
included edema, weight gain and hypoglycemia.
In ADOPT, significantly more women treated with AVANDIA experienced
fractures than did those who received either metformin or glyburide. The
majority of fractures observed were in the upper arm, hand, or foot.
However, the number of women with a hip or spine fracture was low and
similar among the three treatment groups. The incidence of fractures for
men in ADOPT was similar among the three treatment groups.
Other cardiovascular safety data for AVANDIA in ADOPT were added to the
label in November 2007 and show that the results for three endpoints (major
cardiovascular events, heart attacks and total mortality) were not
statistically significantly different between AVANDIA and comparators.
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline on the World Wide
Web at http://www.gsk.com.
Important Safety Information for AVANDIA(R) (rosiglitazone maleate)
AVANDIA, along with diet and exercise, helps improve blood sugar
control in patients with type 2 diabetes.
AVANDIA can cause or worsen heart failure. If you have severe heart
failure (very poor pumping ability of the heart), you cannot be started on
AVANDIA. AVANDIA is also not recommended if you have heart failure with
symptoms (such as shortness of breath or swelling) even if these symptoms
are not severe.
AVANDIA may increase your risk of other heart problems that occur when
there is reduced blood flow to the heart, such as chest pain (angina) or
heart attack (myocardial infarction). This risk appeared higher in patients
taking medicines called nitrates or insulin. Taking AVANDIA with insulin or
with nitrates is not recommended.
If you have chest pain or a feeling of chest pressure, you should seek
immediate medical attention, regardless of what diabetes medicines you are
taking.
If you take AVANDIA, tell your doctor right away if you:
-- Have swollen legs or ankles, a rapid increase in weight or
difficulty breathing, or unusual tiredness
-- Experience changes in vision
-- Become pregnant
-- Review your medical history and tell your doctor if you:
-- Have heart failure or other heart problems
-- Have liver problems or liver disease
-- Are pregnant or are nursing
Women taking AVANDIA should know that AVANDIA may increase the risk of
pregnancy. More fractures have been observed in women taking AVANDIA.
For more information about AVANDIA, please see Patient Information. For
further information on Avandia, please see full Prescribing Information.
Bernadette King
GlaxoSmithKline
215-751-3632
Treatment Option for Appropriate Type 2 Diabetes Patients
PHILADELPHIA, July 14 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:
GSK) announces today that the U.S. Food and Drug Administration (FDA)
updated the prescribing information for AVANDIA(R) (rosiglitazone maleate)
to include clinical findings from A Diabetes Outcome Progression Trial
(ADOPT), a 4- to- 6 year head-to-head study of AVANDIA versus metformin and
glyburide monotherapy in recently diagnosed type 2 diabetes patients. The
percentage of patients with inadequate glucose control at five years was 34
percent with glyburide, 21 percent with metformin and only 15 percent with
AVANDIA. The difference between AVANDIA and the comparators was
statistically significant.
"GSK is pleased that the FDA has approved inclusion of the results from
ADOPT, an important clinical trial that provides substantial long-term
efficacy and safety data on AVANDIA compared to metformin and
sulfonylurea," said Alexander R. Cobitz, MD, PhD, Senior Director,
Metabolism, Clinical Development and Medical Affairs, GlaxoSmithKline. "As
demonstrated in this study, patients treated with AVANDIA achieved greater
sustained glycemic control. Better glycemic control has been proven to
reduce risks of serious complications associated with type 2 diabetes
including blindness, loss of limbs and kidney failure."
Study Design
ADOPT was a large, international, multi-center, randomized,
double-blind, parallel-group study involving 4,351 people, aged 30-75 years
who were recently diagnosed with type 2 diabetes (less than or equal to 3
years) from more than 400 sites throughout North America and Europe. ADOPT,
conducted over a period of 4 to 6 years, assessed the cumulative incidence
of monotherapy failure at five years with AVANDIA, metformin, glyburide, as
defined by consecutive fasting plasma glucose (FPG) >180 mg/dL.
Patients were randomized to receive either AVANDIA 4 mg once daily,
glyburide 2.5 mg once daily, or metformin 500 mg once daily, and doses were
titrated to optimal glycemic control up to a maximum of 4 mg twice daily
for AVANDIA, 7.5 mg twice daily for glyburide, and 1,000 mg twice daily for
metformin. Initial treatment with AVANDIA reduced the risk of monotherapy
failure in people with type 2 diabetes by 32 percent compared to metformin
(p<0.001), and 63 percent compared to glyburide (p<0.001) at five years.
Safety Information from ADOPT
In ADOPT, AVANDIA was reported to be generally well-tolerated among the
large cohort of people with type 2 diabetes who were followed for up to six
years. Incidence of congestive heart failure (CHF) adverse events was the
same among patients treated with AVANDIA (0.8 percent) and metformin (0.8
percent); however, people given glyburide experienced a lower rate of CHF
events (0.2 percent).
Over the duration of the study, commonly reported adverse events
included edema, weight gain and hypoglycemia.
In ADOPT, significantly more women treated with AVANDIA experienced
fractures than did those who received either metformin or glyburide. The
majority of fractures observed were in the upper arm, hand, or foot.
However, the number of women with a hip or spine fracture was low and
similar among the three treatment groups. The incidence of fractures for
men in ADOPT was similar among the three treatment groups.
Other cardiovascular safety data for AVANDIA in ADOPT were added to the
label in November 2007 and show that the results for three endpoints (major
cardiovascular events, heart attacks and total mortality) were not
statistically significantly different between AVANDIA and comparators.
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline on the World Wide
Web at http://www.gsk.com.
Important Safety Information for AVANDIA(R) (rosiglitazone maleate)
AVANDIA, along with diet and exercise, helps improve blood sugar
control in patients with type 2 diabetes.
AVANDIA can cause or worsen heart failure. If you have severe heart
failure (very poor pumping ability of the heart), you cannot be started on
AVANDIA. AVANDIA is also not recommended if you have heart failure with
symptoms (such as shortness of breath or swelling) even if these symptoms
are not severe.
AVANDIA may increase your risk of other heart problems that occur when
there is reduced blood flow to the heart, such as chest pain (angina) or
heart attack (myocardial infarction). This risk appeared higher in patients
taking medicines called nitrates or insulin. Taking AVANDIA with insulin or
with nitrates is not recommended.
If you have chest pain or a feeling of chest pressure, you should seek
immediate medical attention, regardless of what diabetes medicines you are
taking.
If you take AVANDIA, tell your doctor right away if you:
-- Have swollen legs or ankles, a rapid increase in weight or
difficulty breathing, or unusual tiredness
-- Experience changes in vision
-- Become pregnant
-- Review your medical history and tell your doctor if you:
-- Have heart failure or other heart problems
-- Have liver problems or liver disease
-- Are pregnant or are nursing
Women taking AVANDIA should know that AVANDIA may increase the risk of
pregnancy. More fractures have been observed in women taking AVANDIA.
For more information about AVANDIA, please see Patient Information. For
further information on Avandia, please see full Prescribing Information.
Bernadette King
GlaxoSmithKline
215-751-3632
7/14/2008
SaskTel and Alcatel-Lucent launch LifeStat(TM) Remote Monitoring and Health Management enabling effective management of chronic illnesses
SASKATCHEWAN and PARIS, July 10 /PRNewswire/ - SaskTel and
Alcatel-Lucent (Euronext Paris and NYSE: ALU) today announced the launch of
LifeStat Remote Monitoring and Health Management, a service that records
and transmits daily blood glucose and blood pressure readings,
automatically creating confidential, easy-to-use reports that can be viewed
online by the client, their caregivers, and the client's healthcare
professionals. The ongoing development and support of the LifeStat platform
and applications will be managed by SaskTel and Alcatel-Lucent through
their Salveo project, which is based in Saskatchewan.
The Salveo project is funded by SaskTel and Alcatel-Lucent with the
primary objective of becoming a world leader in health and wellness
telemonitoring software applications. A key focus of the Salveo project is
the development of applications that will help keep people healthier and
save costs in the healthcare system.
"LifeStat is a tremendous success story for SaskTel, Alcatel-Lucent and
the Province of Saskatchewan," said Ken Cheveldayoff, Minister of Crown
Corporations for the Province of Saskatchewan. "Not only will LifeStat
result in healthier people globally, it has created 20 new technical and
professional positions in this province."
"The LifeStat technology may hold the key to a new paradigm of diabetes
and chronic illness management in primary care. We are looking forward to
using this technology to introduce standard clinical diabetes management in
the patient's home with the help of the Home and Community Care team and
the patient's family physician," said Dr. Sheldon Tobe, Sunnybrook Hospital
Ontario.
SaskTel will market and sell the LifeStat service directly to consumers
and healthcare providers in Canada, while Alcatel-Lucent will market and
actively sell the Salveo platform to its global customers outside of Canada
under the name Alcatel-Lucent Health and Wellness Application.
"We're very excited to provide patients and caregivers with a powerful
tool to aid in the effective management of chronic illnesses such as
diabetes and hypertension," said Robert Watson, SaskTel President and CEO.
Future LifeStat applications will include monitoring and reporting for
chronic illnesses such as congestive heart failure, Chronic Obstructive
Pulmonary Disease (COPD) and asthma.
"Alcatel-Lucent healthcare solutions help empower providers and improve
patient care. With the launch of LifeStat and the grand opening of Salveo,
SaskTel and Alcatel-Lucent are leveraging our combined expertise to deliver
the next wave of innovative global telehealth solutions," said Alex Giosa,
President of Alcatel-Lucent Canada. "Interest has been strong, particularly
due to the unlimited mobility and low cost per patient of the Salveo
solution."
About Salveo
Salveo is a SaskTel and Alcatel-Lucent project focused on the
development of advanced health and wellness telemonitoring software
applications to address global market needs. Through the Salveo project,
SaskTel and Alcatel-Lucent develop applications that integrate, enhance,
and enable the convergence of personal data in the health, wellness and
lifestyles arena. In Canada, SaskTel markets and sells the platform via its
LifeStat(TM) Remote Monitoring and Health Management service directly to
consumers and healthcare regions. Internationally, Alcatel-Lucent markets
and actively sells under the name Alcatel-Lucent Health and Wellness
Application to its global enterprise customers in the utilities and
healthcare verticals.
About SaskTel
Saskatchewan Telecommunications Holding Corporation (SaskTel) is the
leading full service communications provider in Saskatchewan, offering
competitive voice, data, dial-up and high speed internet, entertainment and
multimedia services, security, web hosting, text and messaging services,
and cellular and wireless data services over its digital networks. The
Corporation also provides security monitoring services through SecurTek,
directory services through DirectWest, in-room communications services to
the healthcare sector through Hospitality Network, telecommunications
consulting and software solutions through SaskTel International and an
out-of-province sales and service channel in Alberta and British Columbia.
SaskTel and its wholly-owned subsidiaries have a workforce of approximately
5,200 full-time, part-time and temporary employees. Visit SaskTel at
http://www.sasktel.com.
About Alcatel-Lucent
Alcatel-Lucent (Euronext Paris and NYSE: ALU) provides solutions that
enable service providers, enterprise and governments worldwide, to deliver
voice, data and video communication services to end-users. As a leader in
fixed, mobile and converged broadband networking, IP technologies,
applications and services, Alcatel-Lucent offers the end-to-end solutions
that enable compelling communications services for people at home, at work
and on the move. With operations in more than 130 countries, Alcatel-Lucent
is a local partner with global reach. The company has the most experienced
global services team in the industry, and one of the largest research,
technology and innovation organizations in the telecommunications industry.
Alcatel-Lucent achieved revenues of Euro 17.8 billion in 2007 and is
incorporated in France, with executive offices located in Paris. For more
information, visit Alcatel-Lucent on the Internet:
http://www.alcatel-lucent.com
Alcatel-Lucent (Euronext Paris and NYSE: ALU) today announced the launch of
LifeStat Remote Monitoring and Health Management, a service that records
and transmits daily blood glucose and blood pressure readings,
automatically creating confidential, easy-to-use reports that can be viewed
online by the client, their caregivers, and the client's healthcare
professionals. The ongoing development and support of the LifeStat platform
and applications will be managed by SaskTel and Alcatel-Lucent through
their Salveo project, which is based in Saskatchewan.
The Salveo project is funded by SaskTel and Alcatel-Lucent with the
primary objective of becoming a world leader in health and wellness
telemonitoring software applications. A key focus of the Salveo project is
the development of applications that will help keep people healthier and
save costs in the healthcare system.
"LifeStat is a tremendous success story for SaskTel, Alcatel-Lucent and
the Province of Saskatchewan," said Ken Cheveldayoff, Minister of Crown
Corporations for the Province of Saskatchewan. "Not only will LifeStat
result in healthier people globally, it has created 20 new technical and
professional positions in this province."
"The LifeStat technology may hold the key to a new paradigm of diabetes
and chronic illness management in primary care. We are looking forward to
using this technology to introduce standard clinical diabetes management in
the patient's home with the help of the Home and Community Care team and
the patient's family physician," said Dr. Sheldon Tobe, Sunnybrook Hospital
Ontario.
SaskTel will market and sell the LifeStat service directly to consumers
and healthcare providers in Canada, while Alcatel-Lucent will market and
actively sell the Salveo platform to its global customers outside of Canada
under the name Alcatel-Lucent Health and Wellness Application.
"We're very excited to provide patients and caregivers with a powerful
tool to aid in the effective management of chronic illnesses such as
diabetes and hypertension," said Robert Watson, SaskTel President and CEO.
Future LifeStat applications will include monitoring and reporting for
chronic illnesses such as congestive heart failure, Chronic Obstructive
Pulmonary Disease (COPD) and asthma.
"Alcatel-Lucent healthcare solutions help empower providers and improve
patient care. With the launch of LifeStat and the grand opening of Salveo,
SaskTel and Alcatel-Lucent are leveraging our combined expertise to deliver
the next wave of innovative global telehealth solutions," said Alex Giosa,
President of Alcatel-Lucent Canada. "Interest has been strong, particularly
due to the unlimited mobility and low cost per patient of the Salveo
solution."
About Salveo
Salveo is a SaskTel and Alcatel-Lucent project focused on the
development of advanced health and wellness telemonitoring software
applications to address global market needs. Through the Salveo project,
SaskTel and Alcatel-Lucent develop applications that integrate, enhance,
and enable the convergence of personal data in the health, wellness and
lifestyles arena. In Canada, SaskTel markets and sells the platform via its
LifeStat(TM) Remote Monitoring and Health Management service directly to
consumers and healthcare regions. Internationally, Alcatel-Lucent markets
and actively sells under the name Alcatel-Lucent Health and Wellness
Application to its global enterprise customers in the utilities and
healthcare verticals.
About SaskTel
Saskatchewan Telecommunications Holding Corporation (SaskTel) is the
leading full service communications provider in Saskatchewan, offering
competitive voice, data, dial-up and high speed internet, entertainment and
multimedia services, security, web hosting, text and messaging services,
and cellular and wireless data services over its digital networks. The
Corporation also provides security monitoring services through SecurTek,
directory services through DirectWest, in-room communications services to
the healthcare sector through Hospitality Network, telecommunications
consulting and software solutions through SaskTel International and an
out-of-province sales and service channel in Alberta and British Columbia.
SaskTel and its wholly-owned subsidiaries have a workforce of approximately
5,200 full-time, part-time and temporary employees. Visit SaskTel at
http://www.sasktel.com.
About Alcatel-Lucent
Alcatel-Lucent (Euronext Paris and NYSE: ALU) provides solutions that
enable service providers, enterprise and governments worldwide, to deliver
voice, data and video communication services to end-users. As a leader in
fixed, mobile and converged broadband networking, IP technologies,
applications and services, Alcatel-Lucent offers the end-to-end solutions
that enable compelling communications services for people at home, at work
and on the move. With operations in more than 130 countries, Alcatel-Lucent
is a local partner with global reach. The company has the most experienced
global services team in the industry, and one of the largest research,
technology and innovation organizations in the telecommunications industry.
Alcatel-Lucent achieved revenues of Euro 17.8 billion in 2007 and is
incorporated in France, with executive offices located in Paris. For more
information, visit Alcatel-Lucent on the Internet:
http://www.alcatel-lucent.com
No More Needles? Georgetown University Teams with Gentag and SAIC to Develop New Glucose Sensor Technology with Wireless Connection to Cell Phones
WASHINGTON, June 18 /PRNewswire/ -- Georgetown University, Gentag,
Inc., and Science Applications International Corporation (SAIC, NYSE: SAI),
have combined forces to develop a non-invasive method for glucose
measurement. The three technology leaders agreed to combine their
respective intellectual property (IP) and expertise to create a new method
to monitor glucose, using disposable skin patches with wireless sensors and
cell phones. The resulting products could eliminate the need for finger
pricking with lancets to draw blood for people of all ages with diabetes.
"This alliance provides an excellent example of cooperation between
academia and industry to bring creative healthcare solutions to the
marketplace," said Claudia Stewart, Vice President of Technology
Commercialization at Georgetown University.
The combined technology will enable the development of a unique new
platform and approach for glucose monitoring and insulin delivery using
cell phones. One potential market application could be a disposable,
wireless skin patch that measures glucose levels and reports those levels
to a cell phone that could also wirelessly control an insulin pump.
By using soft, flexible skin patches, combined with new sensor-chip
technology, the traditional pain and discomfort of the current "finger
prick" technology could be dramatically reduced or eliminated. The patches
would be designed to provide readings once every hour for a 24-hour period.
Using cell phones as readers would allow for convenience of a device many
already use and are familiar with, as well as many other benefits,
including emergency geolocation of patients.
"We expect that this new, painless, disposable, wireless, glucose
sensor technology will significantly improve diabetes monitoring
worldwide," said John Peeters, founder and president of Gentag, Inc.
With funding from the Defense Advanced Research Projects Agency (DARPA)
at the Department of Defense, John Currie, a professor of Physics and
director of Georgetown Advanced Electronics Laboratory (GAEL), Mak
Paranjape, an associate professor of Physics and researcher at GAEL Health
Microsystems at Georgetown, and SAIC researchers Thomas Schneider and
Robert White, who worked in the area of micro-electro-mechanical systems
(MEMS), initially developed the skin patch technology to monitor the status
of soldiers in a battlefield.
The SAIC and Georgetown glucose sensor technology has been developed
for DARPA and can be combined with Gentag's cell phone RFID-sensor reader
platform technology.
Under the terms of the agreement, Gentag, Georgetown and SAIC have
agreed to pool their IP and to sell or license the combined technology to a
company developing glucose monitors or insulin-delivery systems under a
competitive bidding process.
The technology is protected by twenty-one issued and pending U.S. and
international patents. Diabetes is a growing international health problem.
In the United States, medical expenditures totaled $116 billion in 2007 and
were comprised of $27 billion for diabetes care, $58 billion for chronic
diabetes-related complications, and $31 billion for excess general medical
costs according to the American Diabetes Association.
For more information about acquisition or licensing terms, please
contact Claudia Stewart, Vice President, Office of Technology
Commercialization, Georgetown University at (202)-687-7424 or at
cs477@georgetown.edu.
About Gentag
Gentag, Inc. is a technology development company focusing on the
creation of innovative, low-cost, wireless sensor technologies based on
cell phones. The company owns a unique intellectual property portfolio
relating to cell-phone sensor combinations and wireless sensor networks and
was recently awarded Frost & Sullivan's 2008 North American Award for
Technology Innovation. For more information, visit http://www.gentag.com.
About Georgetown University
Georgetown University is the oldest and largest Catholic and Jesuit
university in America, founded in 1789 by Archbishop John Carroll.
Georgetown today is a major student-centered, international, research
university offering respected undergraduate, graduate and professional
programs in Washington, DC, Doha, Qatar and around the world. For more
information about Georgetown University, visit http://www.georgetown.edu
Inc., and Science Applications International Corporation (SAIC, NYSE: SAI),
have combined forces to develop a non-invasive method for glucose
measurement. The three technology leaders agreed to combine their
respective intellectual property (IP) and expertise to create a new method
to monitor glucose, using disposable skin patches with wireless sensors and
cell phones. The resulting products could eliminate the need for finger
pricking with lancets to draw blood for people of all ages with diabetes.
"This alliance provides an excellent example of cooperation between
academia and industry to bring creative healthcare solutions to the
marketplace," said Claudia Stewart, Vice President of Technology
Commercialization at Georgetown University.
The combined technology will enable the development of a unique new
platform and approach for glucose monitoring and insulin delivery using
cell phones. One potential market application could be a disposable,
wireless skin patch that measures glucose levels and reports those levels
to a cell phone that could also wirelessly control an insulin pump.
By using soft, flexible skin patches, combined with new sensor-chip
technology, the traditional pain and discomfort of the current "finger
prick" technology could be dramatically reduced or eliminated. The patches
would be designed to provide readings once every hour for a 24-hour period.
Using cell phones as readers would allow for convenience of a device many
already use and are familiar with, as well as many other benefits,
including emergency geolocation of patients.
"We expect that this new, painless, disposable, wireless, glucose
sensor technology will significantly improve diabetes monitoring
worldwide," said John Peeters, founder and president of Gentag, Inc.
With funding from the Defense Advanced Research Projects Agency (DARPA)
at the Department of Defense, John Currie, a professor of Physics and
director of Georgetown Advanced Electronics Laboratory (GAEL), Mak
Paranjape, an associate professor of Physics and researcher at GAEL Health
Microsystems at Georgetown, and SAIC researchers Thomas Schneider and
Robert White, who worked in the area of micro-electro-mechanical systems
(MEMS), initially developed the skin patch technology to monitor the status
of soldiers in a battlefield.
The SAIC and Georgetown glucose sensor technology has been developed
for DARPA and can be combined with Gentag's cell phone RFID-sensor reader
platform technology.
Under the terms of the agreement, Gentag, Georgetown and SAIC have
agreed to pool their IP and to sell or license the combined technology to a
company developing glucose monitors or insulin-delivery systems under a
competitive bidding process.
The technology is protected by twenty-one issued and pending U.S. and
international patents. Diabetes is a growing international health problem.
In the United States, medical expenditures totaled $116 billion in 2007 and
were comprised of $27 billion for diabetes care, $58 billion for chronic
diabetes-related complications, and $31 billion for excess general medical
costs according to the American Diabetes Association.
For more information about acquisition or licensing terms, please
contact Claudia Stewart, Vice President, Office of Technology
Commercialization, Georgetown University at (202)-687-7424 or at
cs477@georgetown.edu.
About Gentag
Gentag, Inc. is a technology development company focusing on the
creation of innovative, low-cost, wireless sensor technologies based on
cell phones. The company owns a unique intellectual property portfolio
relating to cell-phone sensor combinations and wireless sensor networks and
was recently awarded Frost & Sullivan's 2008 North American Award for
Technology Innovation. For more information, visit http://www.gentag.com.
About Georgetown University
Georgetown University is the oldest and largest Catholic and Jesuit
university in America, founded in 1789 by Archbishop John Carroll.
Georgetown today is a major student-centered, international, research
university offering respected undergraduate, graduate and professional
programs in Washington, DC, Doha, Qatar and around the world. For more
information about Georgetown University, visit http://www.georgetown.edu
Major Studies on Mulberry Leaf Show Its Significant Promise for Millions of Americans Living With Type 2 Diabetes
Clinical Trials Conducted by Researchers at University of Minnesota (VA Hospital) Conclude That Mulberry Leaf Extract May Provide Key Nutritional Health Benefits to Type 2 Diabetics
SAN DIEGO, CA--(Marketwire - July 9, 2008) - Major clinical trials conducted by a team of researchers and doctors at the University of Minnesota (Minneapolis VA Hospital), demonstrate that mulberry leaf, the food source of silkworms, can help markedly stabilize blood sugar levels and inhibit carbohydrate absorption in Type 2 diabetics by providing additional support which enables them to make better dietary and lifestyle choices. In these studies, a proprietary mulberry leaf extract developed by Lee Zhong, M.D., Ph.D., a graduate and former researcher at University of California, Los Angeles (UCLA), was shown conclusively to:
-- Reduce body's absorption of sugars and other carbohydrates
-- Lower post-meal blood sugar spikes and stabilize blood sugar levels: One of these studies published in Diabetes Care, the most widely read diabetes journal, reported an average 44 percent reduction in peak post-meal blood sugar elevations (or spikes).
New data from the U.S. Centers for Disease Control and Prevention (CDC) estimates that the prevalence of diabetes in America is growing at an alarming rate with 24 million people in the U.S. who are now living with diabetes versus 21 million only two years ago. That means nearly 8 percent of the U.S. population has diabetes, and approximately 90 percent of those patients have Type 2 diabetes, greatly linked with obesity, poor diet and a lack of exercise, experts say.
"What is so exciting and promising about our research is that it shows the mulberry leaf, a simple natural ingredient derived from a tree, can nutritionally help improve the blood sugar levels in Type 2 diabetics who struggle every day to follow a balanced diet and maintain a healthy weight, which is essential for managing Type 2 diabetes," said Dr. Zhong. "The ability to maintain stable blood glucose levels around meals is especially important for helping those Type 2 diabetics who are trying to make the right dietary and lifestyle choices to manage their health (or wellness). More and more studies have shown that controlling the blood sugar fluctuations (highs and lows) before and after meals is essential for helping those diagnosed with Type 2 diabetes. Maintaining normal blood sugar levels through nutritional support is vital for those who are trying to manage their blood sugar levels primarily through diet and exercise."
Mulberry (Morus alba) leaf, the food of silkworms, has been used as a healthful food ingredient for humans in India, as well as in Chinese traditional medicine for hundreds of years as a "cooling" herb to remove excessive heats and toxins from the body. However, it was not until recent years that it started gaining attention by doctors and scientists for its promising blood sugar management properties. Studies have shown, among other things, that alkaloids and N-containing sugars isolated from mulberry leaves are potent inhibitors of alpha glucosidase, a key enzyme in carbohydrate and sugar metabolism pathways.
It is important to note, though, that the health benefits of mulberry leaf extracts vary greatly with differences in extraction methods. Research shows that some extracts have basically no effects on blood glucose, while others are comparable to some pharmaceuticals.
"I am very encouraged by these research findings and believe that this natural herbal ingredient, mulberry leaf extract, can be an important complement to a Type 2 diabetes patient's existing management plan," said Janice Baker, M.B.A., R.D., CDE, a registered dietitian and certified diabetes educator. "It's safe and obviously effective based on the clinical data I've reviewed. It appears that the mulberry leaf extract can make managing blood sugar levels and weight just that much easier for people with Type 2 diabetes, which is a constant and daily struggle. Of course, I recommend that all patients first seek their doctor's or dietitian's advice before integrating mulberry extract into their existing treatment plan."
Note: All studies were conducted on a proprietary mulberry leaf extract found exclusively in the all natural dietary diabetic support formula called Glucocil. More information about these studies can be found at http://glucocil.com/clinical.php.
About Glucocil
Scientifically formulated by Dr. Lee Zhong, M.D., Ph.D., a graduate and a former researcher at the University of California, Los Angeles (UCLA), Glucocil is a breakthrough natural herbal formula designed to provide broad nutritional supports to Type 2 diabetics and help them achieve a healthier diet and lifestyle and a more stable blood sugar level. The result of seven years of clinical research and development, Glucocil's proprietary Mulberry Leaf Extract and other key ingredients provide nutritional help people with Type 2 diabetes stabilize their post meal blood sugar levels, reduce the absorption of sugars and other carbohydrates, help to improve insulin sensitivity, and assist in appetite suppression and healthy weight management.
Glucocil is available in the U.S. exclusively via the Glucocil Web site at www.glucocil.com for $39.95 (120-count; one month supply). Complete product information and usage instructions can be found at the Glucocil Web site within the Product Information section.
About Neuliven Health
Based in San Diego, Neuliven Health specializes in the development and delivery of scientifically researched natural remedies designed to address America's pressing health issues. Based on cutting edge herbal ingredients from around the world, Neuliven Health is committed to improving the health and lifestyle of all Americans through natural healing.
*The above statements have not been evaluated by the Food and Drug Administration.
**This product is not intended to diagnose, treat, cure, or prevent any disease. Always seek the advice of a doctor or medical professional before taking Glucocil if you have diabetes or are taking any other medications.
SAN DIEGO, CA--(Marketwire - July 9, 2008) - Major clinical trials conducted by a team of researchers and doctors at the University of Minnesota (Minneapolis VA Hospital), demonstrate that mulberry leaf, the food source of silkworms, can help markedly stabilize blood sugar levels and inhibit carbohydrate absorption in Type 2 diabetics by providing additional support which enables them to make better dietary and lifestyle choices. In these studies, a proprietary mulberry leaf extract developed by Lee Zhong, M.D., Ph.D., a graduate and former researcher at University of California, Los Angeles (UCLA), was shown conclusively to:
-- Reduce body's absorption of sugars and other carbohydrates
-- Lower post-meal blood sugar spikes and stabilize blood sugar levels: One of these studies published in Diabetes Care, the most widely read diabetes journal, reported an average 44 percent reduction in peak post-meal blood sugar elevations (or spikes).
New data from the U.S. Centers for Disease Control and Prevention (CDC) estimates that the prevalence of diabetes in America is growing at an alarming rate with 24 million people in the U.S. who are now living with diabetes versus 21 million only two years ago. That means nearly 8 percent of the U.S. population has diabetes, and approximately 90 percent of those patients have Type 2 diabetes, greatly linked with obesity, poor diet and a lack of exercise, experts say.
"What is so exciting and promising about our research is that it shows the mulberry leaf, a simple natural ingredient derived from a tree, can nutritionally help improve the blood sugar levels in Type 2 diabetics who struggle every day to follow a balanced diet and maintain a healthy weight, which is essential for managing Type 2 diabetes," said Dr. Zhong. "The ability to maintain stable blood glucose levels around meals is especially important for helping those Type 2 diabetics who are trying to make the right dietary and lifestyle choices to manage their health (or wellness). More and more studies have shown that controlling the blood sugar fluctuations (highs and lows) before and after meals is essential for helping those diagnosed with Type 2 diabetes. Maintaining normal blood sugar levels through nutritional support is vital for those who are trying to manage their blood sugar levels primarily through diet and exercise."
Mulberry (Morus alba) leaf, the food of silkworms, has been used as a healthful food ingredient for humans in India, as well as in Chinese traditional medicine for hundreds of years as a "cooling" herb to remove excessive heats and toxins from the body. However, it was not until recent years that it started gaining attention by doctors and scientists for its promising blood sugar management properties. Studies have shown, among other things, that alkaloids and N-containing sugars isolated from mulberry leaves are potent inhibitors of alpha glucosidase, a key enzyme in carbohydrate and sugar metabolism pathways.
It is important to note, though, that the health benefits of mulberry leaf extracts vary greatly with differences in extraction methods. Research shows that some extracts have basically no effects on blood glucose, while others are comparable to some pharmaceuticals.
"I am very encouraged by these research findings and believe that this natural herbal ingredient, mulberry leaf extract, can be an important complement to a Type 2 diabetes patient's existing management plan," said Janice Baker, M.B.A., R.D., CDE, a registered dietitian and certified diabetes educator. "It's safe and obviously effective based on the clinical data I've reviewed. It appears that the mulberry leaf extract can make managing blood sugar levels and weight just that much easier for people with Type 2 diabetes, which is a constant and daily struggle. Of course, I recommend that all patients first seek their doctor's or dietitian's advice before integrating mulberry extract into their existing treatment plan."
Note: All studies were conducted on a proprietary mulberry leaf extract found exclusively in the all natural dietary diabetic support formula called Glucocil. More information about these studies can be found at http://glucocil.com/clinical.php.
About Glucocil
Scientifically formulated by Dr. Lee Zhong, M.D., Ph.D., a graduate and a former researcher at the University of California, Los Angeles (UCLA), Glucocil is a breakthrough natural herbal formula designed to provide broad nutritional supports to Type 2 diabetics and help them achieve a healthier diet and lifestyle and a more stable blood sugar level. The result of seven years of clinical research and development, Glucocil's proprietary Mulberry Leaf Extract and other key ingredients provide nutritional help people with Type 2 diabetes stabilize their post meal blood sugar levels, reduce the absorption of sugars and other carbohydrates, help to improve insulin sensitivity, and assist in appetite suppression and healthy weight management.
Glucocil is available in the U.S. exclusively via the Glucocil Web site at www.glucocil.com for $39.95 (120-count; one month supply). Complete product information and usage instructions can be found at the Glucocil Web site within the Product Information section.
About Neuliven Health
Based in San Diego, Neuliven Health specializes in the development and delivery of scientifically researched natural remedies designed to address America's pressing health issues. Based on cutting edge herbal ingredients from around the world, Neuliven Health is committed to improving the health and lifestyle of all Americans through natural healing.
*The above statements have not been evaluated by the Food and Drug Administration.
**This product is not intended to diagnose, treat, cure, or prevent any disease. Always seek the advice of a doctor or medical professional before taking Glucocil if you have diabetes or are taking any other medications.
7/09/2008
How much fiber do you need each day?
The National Academy of Sciences' Institute of Medicine, which provides science-based advice on matters of medicine and health, gives the following daily recommendations for adults:
Age 50 and younger Age 51 and older
Men 38 grams 30 grams
Women 25 grams 21 grams
Your best fiber choices
If you aren't getting enough fiber each day, you may need to boost your intake. Good choices include:
• Grains and whole-grain products
• Fruits
• Vegetables
• Beans, peas and other legumes
• Nuts and seeds
Refined or processed foods — such as fruit juice, white bread and pasta, and non-whole-grain cereals — are lower in fiber content. The grain-refining process removes the outer coat (bran) from the grain, which lowers its fiber content. Similarly, removing the skin from fruits and vegetables decreases their fiber content.
So what foods are your best bets? This list shows the amount of dietary fiber in several types of foods.
Food item Fiber content in grams*
Split peas, cooked, 1 cup 16.3
Red kidney beans, boiled, 1 cup 13.1
Raspberries, raw, 1 cup 8.0
Whole-wheat spaghetti, 1 cup 6.3
Oat bran muffin, medium 5.2
Pear, medium with skin 5.1
Broccoli, boiled, 1 cup 5.1
Apple, medium with skin 4.4
Oatmeal, quick, regular or instant, cooked, 1 cup 4.0
Green beans, cooked, 1 cup 4.0
Brown rice, cooked, 1 cup 3.5
Popcorn, air-popped, 2 cups 2.3
Whole-wheat bread, one slice 1.9
*Fiber content can vary between brands.
Source: USDA National Nutrient Database for Standard Reference, 2007
Whole foods rather than fiber supplements are generally better. Fiber supplements, don't provide the vitamins, minerals and other beneficial nutrients that high-fiber foods do. However, some people may still need a fiber supplement if dietary changes aren't sufficient, or if they have certain medical conditions, such as irritable bowel syndrome. Check with your doctor if you feel you need to take fiber supplements.
Age 50 and younger Age 51 and older
Men 38 grams 30 grams
Women 25 grams 21 grams
Your best fiber choices
If you aren't getting enough fiber each day, you may need to boost your intake. Good choices include:
• Grains and whole-grain products
• Fruits
• Vegetables
• Beans, peas and other legumes
• Nuts and seeds
Refined or processed foods — such as fruit juice, white bread and pasta, and non-whole-grain cereals — are lower in fiber content. The grain-refining process removes the outer coat (bran) from the grain, which lowers its fiber content. Similarly, removing the skin from fruits and vegetables decreases their fiber content.
So what foods are your best bets? This list shows the amount of dietary fiber in several types of foods.
Food item Fiber content in grams*
Split peas, cooked, 1 cup 16.3
Red kidney beans, boiled, 1 cup 13.1
Raspberries, raw, 1 cup 8.0
Whole-wheat spaghetti, 1 cup 6.3
Oat bran muffin, medium 5.2
Pear, medium with skin 5.1
Broccoli, boiled, 1 cup 5.1
Apple, medium with skin 4.4
Oatmeal, quick, regular or instant, cooked, 1 cup 4.0
Green beans, cooked, 1 cup 4.0
Brown rice, cooked, 1 cup 3.5
Popcorn, air-popped, 2 cups 2.3
Whole-wheat bread, one slice 1.9
*Fiber content can vary between brands.
Source: USDA National Nutrient Database for Standard Reference, 2007
Whole foods rather than fiber supplements are generally better. Fiber supplements, don't provide the vitamins, minerals and other beneficial nutrients that high-fiber foods do. However, some people may still need a fiber supplement if dietary changes aren't sufficient, or if they have certain medical conditions, such as irritable bowel syndrome. Check with your doctor if you feel you need to take fiber supplements.
Fiber for diabetes diet
Eat more fiber. You've probably heard it before. But do you know why fiber is so good for your health and diabetes?
Benefits of a high-fiber diet
A high-fiber diet has many benefits, which include:
• Prevents constipation.
• Lowers your risk of digestive conditions.
• Lowers blood cholesterol levels.
• Controls blood sugar levels.
• Aids in weight loss.
A recent study published in the May issue of The New England Journal of Medicine found that blood sugar levels were reduced by 8.9% on a high fiber diet. It also lowered cholesterol and triglycerides.
Fiber comes from the cell walls of plants. Additionally, fiber and water work together to keep the bowels regular.
Fiber is often classified into two categories: those that don't dissolve in water (insoluble fiber) and those that do (soluble fiber).
• Insoluble fiber. This type of fiber promotes the movement of material through your digestive system and increases stool bulk, so it can be of benefit to those who struggle with constipation or irregular stools. Whole-wheat flour, wheat bran, nuts and many vegetables are good sources of insoluble fiber.
• Soluble fiber. This type of fiber dissolves in water to form a gel-like material. It can help lower blood cholesterol and glucose levels. You can find generous quantities of soluble fiber in oats, peas, beans, apples, citrus fruits, carrots, barley and psyllium.
If you need to add more fiber to your diet, don't worry. Increasing the amount you eat each day isn't difficult. Find out how much dietary fiber you need and ways to include more high-fiber foods into your daily meals and snacks.
Unfortunately, the majority of high fiber foods also contain a high amount of carbohydrates, and if you are diabetic, those will increase your blood sugar levels dramatically.
Below are lists of low-carb foods that are also high in fiber, along with the approximate number of grams of fiber they contain.
The fiber content shown is for a quantity of 1/2 cup.
Low-Carb Fruits
•Blackberries, 4.9 grams
•Avocado, 3.8 grams
•Medium-sized Apple, 3.6 grams
•Raspberries, 2.6 grams
•Blueberries, 2.1 grams
•Cherries, 1.5 grams
•Strawberries, 1.4 grams
Low-Carb Vegetables
•Brussels Sprouts, 3.1 grams
•Broccoli, 2.7 grams
•Greens, cooked, 2-4 grams (beet greens, collards, kale, spinach, and turnip greens)
•Mushrooms, canned, 2.0 grams
•Green Beans, 1.4 - 2 grams (broad beans, pole beans, and snap beans)
•Asparagus, 1.8 grams
•Okra, 1.6 grams
•Zucchini, 1.3 grams
•Yellow Summer Squash, 1.3 grams
•Cauliflower, 1.4 grams
•Onions, 1.3 grams
•Celery, 1.1 grams
•Peppers, 1.1 grams
Including more of the above foods in your diet will help in lowering blood sugar and cholesterol levels.
You should make changes to your diet to include more high fiber foods, and do it gradually. Just add a few grams at a time so that your digestive system can adjust.
It’s best to increase the amount of fiber in your diet over several weeks. This prevents problems with stomach-aches, bloating, gas, and diarrhea.
The message is, increase the amount of fiber in your diet!
Benefits of a high-fiber diet
A high-fiber diet has many benefits, which include:
• Prevents constipation.
• Lowers your risk of digestive conditions.
• Lowers blood cholesterol levels.
• Controls blood sugar levels.
• Aids in weight loss.
A recent study published in the May issue of The New England Journal of Medicine found that blood sugar levels were reduced by 8.9% on a high fiber diet. It also lowered cholesterol and triglycerides.
Fiber comes from the cell walls of plants. Additionally, fiber and water work together to keep the bowels regular.
Fiber is often classified into two categories: those that don't dissolve in water (insoluble fiber) and those that do (soluble fiber).
• Insoluble fiber. This type of fiber promotes the movement of material through your digestive system and increases stool bulk, so it can be of benefit to those who struggle with constipation or irregular stools. Whole-wheat flour, wheat bran, nuts and many vegetables are good sources of insoluble fiber.
• Soluble fiber. This type of fiber dissolves in water to form a gel-like material. It can help lower blood cholesterol and glucose levels. You can find generous quantities of soluble fiber in oats, peas, beans, apples, citrus fruits, carrots, barley and psyllium.
If you need to add more fiber to your diet, don't worry. Increasing the amount you eat each day isn't difficult. Find out how much dietary fiber you need and ways to include more high-fiber foods into your daily meals and snacks.
Unfortunately, the majority of high fiber foods also contain a high amount of carbohydrates, and if you are diabetic, those will increase your blood sugar levels dramatically.
Below are lists of low-carb foods that are also high in fiber, along with the approximate number of grams of fiber they contain.
The fiber content shown is for a quantity of 1/2 cup.
Low-Carb Fruits
•Blackberries, 4.9 grams
•Avocado, 3.8 grams
•Medium-sized Apple, 3.6 grams
•Raspberries, 2.6 grams
•Blueberries, 2.1 grams
•Cherries, 1.5 grams
•Strawberries, 1.4 grams
Low-Carb Vegetables
•Brussels Sprouts, 3.1 grams
•Broccoli, 2.7 grams
•Greens, cooked, 2-4 grams (beet greens, collards, kale, spinach, and turnip greens)
•Mushrooms, canned, 2.0 grams
•Green Beans, 1.4 - 2 grams (broad beans, pole beans, and snap beans)
•Asparagus, 1.8 grams
•Okra, 1.6 grams
•Zucchini, 1.3 grams
•Yellow Summer Squash, 1.3 grams
•Cauliflower, 1.4 grams
•Onions, 1.3 grams
•Celery, 1.1 grams
•Peppers, 1.1 grams
Including more of the above foods in your diet will help in lowering blood sugar and cholesterol levels.
You should make changes to your diet to include more high fiber foods, and do it gradually. Just add a few grams at a time so that your digestive system can adjust.
It’s best to increase the amount of fiber in your diet over several weeks. This prevents problems with stomach-aches, bloating, gas, and diarrhea.
The message is, increase the amount of fiber in your diet!
7/07/2008
Healthy Interactions and the British Dietetic Association Form Five-Year Partnership to Promote Better Nutrition
BIRMINGHAM, England--(BUSINESS WIRE), 23th June 2008--Healthy Interactions, a global leader in health education, announces the beginning of a five-year partnership with the British Dietetic Association (BDA), the UK’s largest organisation of food and nutrition professionals. The collaboration will focus on the creation of a variety of programmes, using a unique methodology to address food and nutrition issues. The UK will be the first market in the world to develop training and education resources to tackle such issues.
The collaboration aims to help combat growing health problems in the UK, such as the rising levels of diabetes and obesity. If no action is taken to reverse current trends, 60 percent of British men, half of female Britons and one-quarter of children in the UK will be obese by 20501. The UK Healthy Kids Conversation MapTM programme - the first initiative in development and due for launch in 2009 - will be available across the country, and ultimately be offered to 22,000 primary schools in the UK. Dietitians, teachers and health professionals will be able to use The Conversation Map programme to tackle childhood obesity.
The Conversation Map methodology is a powerful new learning method that uses conversation-based, peer-to-peer experiences, developed over the last ten years in more than fifty countries, to create a deeper level of personal health engagement. This approach has been successful in helping people determine their personal plans for living with a disease or achieving a specific health objective.
Announcing the partnership Pauline Douglas, honorary chairman of the British Dietetic Association, said: "This is a really exciting opportunity for the BDA, and we are looking forward to working closely with Healthy Interactions in developing these Conversation Map tools in the UK. Once these tools have been developed tested and finalised we will offer them to patient groups and other medical support groups as a new option for delivering diet and nutritional information. Getting people of all ages to change their lifestyle in the long-term is extremely difficult. But, we believe that Healthy Interactions, through its Conversation Map tools, takes a very innovative approach by encouraging active discussion between patients and healthcare professionals in developing their individual treatment plans, which lead to behaviour change.”
Peter Gorman, co-founder of Healthy Interactions said: “. We believe that the Conversation Map™ approach linked with the knowledge of the BDA will prove to be very effective in helping people to make the personal changes they need to take control and live healthier lives. We are in initial discussions with retail, sport and health organisations who are very interested in supporting the first initiative involving children from across the UK.”
Healthy Interactions recently announced the launch of the Diabetes Conversation Map™ Programme, in collaboration with Diabetes UK. The programme aims to help the 2.2 million people in the UK who have been diagnosed with diabetes2.
1Foresight: Tackling Obesities: Future Choices project, www.foresight.gov.uk published in October 2007
2http://www.diabetes.org.uk/Professionals/Information_resources/ Reports/Diabetes_prevalence_2006/
About Healthy Interactions, Inc.
Healthy Interactions is devoted to driving Personal Health Engagement -- our term for helping individuals commit to healthier actions. We create “Aha! Moments” that inspire people to change personal health behaviors. Healthy Interactions builds partnerships with leading medical and disease associations, not-for-profit organizations, corporations, and caring healthcare professionals trained in our approaches, enabling millions of people to take control of their health and live their best lives. Founded in 2003, Healthy Interactions is headquartered in Chicago, USA. For more information, visit www.healthyi.co.uk.
About the British Dietetic Association
The British Dietetic Association, founded in 1936, is the professional association for registered dietitians in Great Britain and Northern Ireland. It is the nation’s largest organisation of food and nutrition professionals with over 6,000 members. Registered dietitians are the only qualified health professionals that assess, diagnose and treat diet and nutrition problems at an individual and wider public health level. Uniquely, dietitians use the most up to date public health and scientific research on food, health and disease, which they translate into practical guidance to enable people to make appropriate lifestyle and food choices.
Dietitians are the only nutrition professionals to be statutorily regulated, and governed by an ethical code, to ensure that they always work to the highest standard. Dietitians work in the NHS, private practice, industry, education, research, sport, media, public relations, publishing, NGOs and government. Their advice influences food and health policy across the spectrum from government, local communities and individuals.
The collaboration aims to help combat growing health problems in the UK, such as the rising levels of diabetes and obesity. If no action is taken to reverse current trends, 60 percent of British men, half of female Britons and one-quarter of children in the UK will be obese by 20501. The UK Healthy Kids Conversation MapTM programme - the first initiative in development and due for launch in 2009 - will be available across the country, and ultimately be offered to 22,000 primary schools in the UK. Dietitians, teachers and health professionals will be able to use The Conversation Map programme to tackle childhood obesity.
The Conversation Map methodology is a powerful new learning method that uses conversation-based, peer-to-peer experiences, developed over the last ten years in more than fifty countries, to create a deeper level of personal health engagement. This approach has been successful in helping people determine their personal plans for living with a disease or achieving a specific health objective.
Announcing the partnership Pauline Douglas, honorary chairman of the British Dietetic Association, said: "This is a really exciting opportunity for the BDA, and we are looking forward to working closely with Healthy Interactions in developing these Conversation Map tools in the UK. Once these tools have been developed tested and finalised we will offer them to patient groups and other medical support groups as a new option for delivering diet and nutritional information. Getting people of all ages to change their lifestyle in the long-term is extremely difficult. But, we believe that Healthy Interactions, through its Conversation Map tools, takes a very innovative approach by encouraging active discussion between patients and healthcare professionals in developing their individual treatment plans, which lead to behaviour change.”
Peter Gorman, co-founder of Healthy Interactions said: “. We believe that the Conversation Map™ approach linked with the knowledge of the BDA will prove to be very effective in helping people to make the personal changes they need to take control and live healthier lives. We are in initial discussions with retail, sport and health organisations who are very interested in supporting the first initiative involving children from across the UK.”
Healthy Interactions recently announced the launch of the Diabetes Conversation Map™ Programme, in collaboration with Diabetes UK. The programme aims to help the 2.2 million people in the UK who have been diagnosed with diabetes2.
1Foresight: Tackling Obesities: Future Choices project, www.foresight.gov.uk published in October 2007
2http://www.diabetes.org.uk/Professionals/Information_resources/ Reports/Diabetes_prevalence_2006/
About Healthy Interactions, Inc.
Healthy Interactions is devoted to driving Personal Health Engagement -- our term for helping individuals commit to healthier actions. We create “Aha! Moments” that inspire people to change personal health behaviors. Healthy Interactions builds partnerships with leading medical and disease associations, not-for-profit organizations, corporations, and caring healthcare professionals trained in our approaches, enabling millions of people to take control of their health and live their best lives. Founded in 2003, Healthy Interactions is headquartered in Chicago, USA. For more information, visit www.healthyi.co.uk.
About the British Dietetic Association
The British Dietetic Association, founded in 1936, is the professional association for registered dietitians in Great Britain and Northern Ireland. It is the nation’s largest organisation of food and nutrition professionals with over 6,000 members. Registered dietitians are the only qualified health professionals that assess, diagnose and treat diet and nutrition problems at an individual and wider public health level. Uniquely, dietitians use the most up to date public health and scientific research on food, health and disease, which they translate into practical guidance to enable people to make appropriate lifestyle and food choices.
Dietitians are the only nutrition professionals to be statutorily regulated, and governed by an ethical code, to ensure that they always work to the highest standard. Dietitians work in the NHS, private practice, industry, education, research, sport, media, public relations, publishing, NGOs and government. Their advice influences food and health policy across the spectrum from government, local communities and individuals.
FDA Approves PrandiMet™, a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes
ATLANTA & PRINCETON, N.J.--(BUSINESS WIRE), 24th June 2008--Sciele Pharma, Inc. (NASDAQ:SCRX) and Novo Nordisk Inc. today announced that the U.S. Food and Drug Administration (FDA) approved PrandiMet™ (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin®) and insulin sensitizer, metformin, for the treatment of type 2 diabetes. Under a previously announced agreement, Sciele Pharma will exclusively market PrandiMet™ to physicians in the U.S. Sciele Pharma anticipates that PrandiMet™ will be available to physicians and patients in the U.S. in the second half of 2008.
PrandiMet™ has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin.
The FDA approved PrandiMet™ based upon data demonstrating that PrandiMet™ 1 mg./500 mg. and 2 mg./500 mg. resulted in similar bioequivalence to co-administration of corresponding doses of repaglinide and metformin HCl as individual tablets.1
“As the world’s leading diabetes care company, Novo Nordisk is dedicated to providing a broad portfolio of treatments that respond to each stage of diabetes. With PrandiMet™, physicians will have a simplified option for Prandin® and metformin combination therapy,” said Jerzy Gruhn, president, Novo Nordisk Inc.
PrandiMet™ is the first and only fixed-dose combination of a fast-acting secretagogue and metformin. The combination of metformin and repaglinide has been shown to safely and effectively reduce hemoglobin A1c levels. PrandiMet™ offers the convenience of two medications in one pill. PrandiMet™ is comprised of two well-established anti-diabetic medications: Prandin®, a fast-acting insulin secretagogue and metformin, an insulin sensitizer. Prandin® stimulates the release of insulin from the pancreas after a meal, thereby reducing PPG. Metformin decreases the amount sugar produced by the liver, reducing FPG, and helps the body respond better to the insulin it makes naturally.
“We are very pleased with approval of PrandiMet™, an important new treatment option for people struggling to keep their blood glucose in control,” said Patrick Fourteau, Chief Executive Officer of Sciele Pharma, Inc. “We’ve seen that many patients need more than one therapy to control their type 2 diabetes and the combination of Prandin® and metformin in one pill will give patients convenient access to two medications trusted for their efficacy and safety.”
About PrandiMet™
PrandiMet™ is indicated for the treatment of type 2 diabetes and includes two products with well-established data for safety and efficacy: repaglinide (Prandin®) and metformin. It is the first fixed-dose combination of a fast acting insulin secretagogue and metformin, combining two antihyperglycemic agents with different mechanisms of action in one tablet to improve glycemic control.
PrandiMet™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin HCl or who have inadequate glycemic control on a meglitinide alone or metformin HCl alone. Do not use to treat type 1 diabetes or diabetic ketoacidosis.
Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. Symptoms include malaise, myalgias, respiratory distress, increasing somnolence and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. If acidosis is suspected, discontinue PrandiMet™ and hospitalize the patient immediately.
PrandiMet™ is contraindicated in patients with renal impairment, metabolic acidosis, including diabetic ketoacidosis, or patients receiving both gemfibrozil and itraconazole. Before initiation of therapy with PrandiMet™ and at least annually thereafter, renal function should be assessed and verified as normal. In patients in whom development of renal impairment is anticipated, renal function should be assessed more frequently and PrandiMet™ discontinued if evidence of renal impairment is present. PrandiMet™ should generally be avoided in patients with hepatic impairment.
PrandiMet™ should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials and may be resumed 48 hours after the procedure only after renal function has been re-evaluated and found to be normal. Repaglinide is not indicated for use in combination with NPH insulin.
Hypoglycemia and headache were the most common adverse reactions (≥10%) reported among patients treated with repaglinide in combination with metformin HCl. Gastrointestinal reactions (e.g. diarrhea, nausea, and vomiting) are the most common adverse reactions with metformin HCl treatment and are more frequent at higher metformin HCl doses.
PrandiMet™ works to control three abnormalities of type 2 diabetes: impaired insulin secretion; insulin resistance and excessive hepatic glucose production.
PrandiMet™ is available in two dosage strengths – 1mg. (repaglinide)/500mg. (metformin) and 2 mg. (repaglinide)/500mg. (metformin), recommended to be dosed at two-three times a day with meals.
Full prescribing information for PrandiMet™ is available by contacting Novo Nordisk Inc. or visiting www.prandimet.com.
About Type 2 Diabetes
Type 2 Diabetes (diabetes mellitus) is a serious chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone needed to convert sugar, starches and other food into energy needed for daily life.
In the United States, an estimated 20.8 million people have diabetes (7% of the population). Of the total, 6.2 million remain undiagnosed and about 1.5 million new cases of diabetes are diagnosed each year.2 Only 57% of those with diabetes are meeting the recommended glucose levels (hemoglobin A1c goal of 7.0% or less)3 and those who are undiagnosed or not controlled are putting themselves at risk for serious complications.
About Novo Nordisk
Novo Nordisk is a healthcare company with an 85-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk’s business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. With headquarters in Denmark, Novo Nordisk employs more than 26,000 employees in 80 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO.' For global information, visit novonordisk.com; for United States information, visit novonordisk-us.com.
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular, Diabetes, Women’s Health and Pediatrics. The Company’s Cardiovascular and Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women’s Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company’s success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Execution Excellence, Simplicity, and Teamwork.
Safe Harbor Statement
This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations. With respect to such forward-looking statements, we seek the protections afforded by the Private Securities Litigation Reform Act of 1995. These risks include, without limitation:
We may not attain expected revenues and earnings. If we are unsuccessful in obtaining or renewing third party payor contracts for our products, we may experience reductions in sales levels and may fail to reach anticipated sales levels. If demand for our products exceeds our initial expectations or the ability of our suppliers to provide demand-meeting quantities of product and samples, our future ability to sell these products could be adversely impacted. The potential growth rate for our promoted products may be limited by slower growth for the class of drugs to which our promoted products belong and unfavorable clinical studies about such class of drugs. We will not realize anticipated sales if our products and our licensors’ products do not receive regulatory approval.
We may encounter problems in the manufacture or supply of our products, for which we depend entirely on third parties. Strong competition exists in the sale of our promoted products, which could adversely affect expected growth of our promoted products’ sales or increase our costs to sell our promoted products. We may not be able to protect our competitive position for our promoted products from patent infringers. If generic competitors that compete with any of our products are introduced, our revenues may be adversely affected.
Certain of our products have experienced manufacturing issues. If the issues recur and cannot be resolved, our ability to acquire product for sale and sampling will be adversely affected. We may incur unexpected costs in integrating new products into our operations.
We may be unable to develop or market line extensions for our products or, even if developed, obtain patent protection for our line extensions; further, introductions by us of line extensions of our existing products may require that we make unexpected changes in our estimates for future product returns and reserves for obsolete inventory. If these risks occur, our financial results could be adversely affected.
If we have difficulties acquiring new products or rights to market new products from third parties, our financial results could be adversely impacted. Our licensor/supplier can terminate our rights to commercialize Nitrolingual and the 60mg dose size of this product has not yet met our expectation.
We may not experience the beneficial results of our acquisitions that we expect to receive, and the acquired products may not meet our sales expectations.
We depend on a small senior management group, the departure of any member of which would likely adversely affect our business if a suitable replacement member could not be retained.
An adverse interpretation or ruling by one of the taxing jurisdictions in which we operate could adversely impact our operating results. An adverse judgment in the pending patent litigation involving Prandin or in the securities class action litigation in which we and certain current and former directors and executive officers are defendants could have a material adverse effect on our financial results and liquidity.
Our business is subject to increasing government price controls and other healthcare cost containment measures. Side effects or marketing or manufacturing problems with our products could result in product liability claims which could be costly to defend and could result in the withdrawal or recall of products from the market which would adversely affect our business. We may be found noncompliant with applicable federal, state or international laws, rules or regulations which could result in fines and/or product recalls or otherwise cause us to expend significant resources to correct such non-compliance.
A small number of customers account for a large portion of our sales and the loss of one of them, or changes in their purchasing patterns, could result in substantially reduced sales, substantially and adversely impacting our financial results. If third-party payors do not adequately reimburse patients for our products, doctors may not prescribe them.
We rely on operational data obtained from IMS, an industry accepted data source. IMS data may not accurately reflect actual prescriptions (for instance, we believe IMS data does not capture all product prescriptions from some non-retail channels).
Our business and products are highly regulated; the regulatory status of some of our products makes these products subject to increased competition and other risks; and we run the risk that we, or third parties on whom we rely, could violate the governing regulations.
Some unforeseen difficulties may occur.
The above are some of the principal factors that could cause actual results to differ materially from those described in the forward-looking statements included above. These factors are not intended to represent a complete list of all risks and uncertainties inherent in our business, and should be read in conjunction with the more detailed cautionary statements and risk factors included in our other filings with the Securities and Exchange Commission.
PrandiMet™ has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin.
The FDA approved PrandiMet™ based upon data demonstrating that PrandiMet™ 1 mg./500 mg. and 2 mg./500 mg. resulted in similar bioequivalence to co-administration of corresponding doses of repaglinide and metformin HCl as individual tablets.1
“As the world’s leading diabetes care company, Novo Nordisk is dedicated to providing a broad portfolio of treatments that respond to each stage of diabetes. With PrandiMet™, physicians will have a simplified option for Prandin® and metformin combination therapy,” said Jerzy Gruhn, president, Novo Nordisk Inc.
PrandiMet™ is the first and only fixed-dose combination of a fast-acting secretagogue and metformin. The combination of metformin and repaglinide has been shown to safely and effectively reduce hemoglobin A1c levels. PrandiMet™ offers the convenience of two medications in one pill. PrandiMet™ is comprised of two well-established anti-diabetic medications: Prandin®, a fast-acting insulin secretagogue and metformin, an insulin sensitizer. Prandin® stimulates the release of insulin from the pancreas after a meal, thereby reducing PPG. Metformin decreases the amount sugar produced by the liver, reducing FPG, and helps the body respond better to the insulin it makes naturally.
“We are very pleased with approval of PrandiMet™, an important new treatment option for people struggling to keep their blood glucose in control,” said Patrick Fourteau, Chief Executive Officer of Sciele Pharma, Inc. “We’ve seen that many patients need more than one therapy to control their type 2 diabetes and the combination of Prandin® and metformin in one pill will give patients convenient access to two medications trusted for their efficacy and safety.”
About PrandiMet™
PrandiMet™ is indicated for the treatment of type 2 diabetes and includes two products with well-established data for safety and efficacy: repaglinide (Prandin®) and metformin. It is the first fixed-dose combination of a fast acting insulin secretagogue and metformin, combining two antihyperglycemic agents with different mechanisms of action in one tablet to improve glycemic control.
PrandiMet™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin HCl or who have inadequate glycemic control on a meglitinide alone or metformin HCl alone. Do not use to treat type 1 diabetes or diabetic ketoacidosis.
Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. Symptoms include malaise, myalgias, respiratory distress, increasing somnolence and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. If acidosis is suspected, discontinue PrandiMet™ and hospitalize the patient immediately.
PrandiMet™ is contraindicated in patients with renal impairment, metabolic acidosis, including diabetic ketoacidosis, or patients receiving both gemfibrozil and itraconazole. Before initiation of therapy with PrandiMet™ and at least annually thereafter, renal function should be assessed and verified as normal. In patients in whom development of renal impairment is anticipated, renal function should be assessed more frequently and PrandiMet™ discontinued if evidence of renal impairment is present. PrandiMet™ should generally be avoided in patients with hepatic impairment.
PrandiMet™ should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials and may be resumed 48 hours after the procedure only after renal function has been re-evaluated and found to be normal. Repaglinide is not indicated for use in combination with NPH insulin.
Hypoglycemia and headache were the most common adverse reactions (≥10%) reported among patients treated with repaglinide in combination with metformin HCl. Gastrointestinal reactions (e.g. diarrhea, nausea, and vomiting) are the most common adverse reactions with metformin HCl treatment and are more frequent at higher metformin HCl doses.
PrandiMet™ works to control three abnormalities of type 2 diabetes: impaired insulin secretion; insulin resistance and excessive hepatic glucose production.
PrandiMet™ is available in two dosage strengths – 1mg. (repaglinide)/500mg. (metformin) and 2 mg. (repaglinide)/500mg. (metformin), recommended to be dosed at two-three times a day with meals.
Full prescribing information for PrandiMet™ is available by contacting Novo Nordisk Inc. or visiting www.prandimet.com.
About Type 2 Diabetes
Type 2 Diabetes (diabetes mellitus) is a serious chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone needed to convert sugar, starches and other food into energy needed for daily life.
In the United States, an estimated 20.8 million people have diabetes (7% of the population). Of the total, 6.2 million remain undiagnosed and about 1.5 million new cases of diabetes are diagnosed each year.2 Only 57% of those with diabetes are meeting the recommended glucose levels (hemoglobin A1c goal of 7.0% or less)3 and those who are undiagnosed or not controlled are putting themselves at risk for serious complications.
About Novo Nordisk
Novo Nordisk is a healthcare company with an 85-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk’s business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. With headquarters in Denmark, Novo Nordisk employs more than 26,000 employees in 80 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO.' For global information, visit novonordisk.com; for United States information, visit novonordisk-us.com.
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular, Diabetes, Women’s Health and Pediatrics. The Company’s Cardiovascular and Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women’s Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company’s success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Execution Excellence, Simplicity, and Teamwork.
Safe Harbor Statement
This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations. With respect to such forward-looking statements, we seek the protections afforded by the Private Securities Litigation Reform Act of 1995. These risks include, without limitation:
We may not attain expected revenues and earnings. If we are unsuccessful in obtaining or renewing third party payor contracts for our products, we may experience reductions in sales levels and may fail to reach anticipated sales levels. If demand for our products exceeds our initial expectations or the ability of our suppliers to provide demand-meeting quantities of product and samples, our future ability to sell these products could be adversely impacted. The potential growth rate for our promoted products may be limited by slower growth for the class of drugs to which our promoted products belong and unfavorable clinical studies about such class of drugs. We will not realize anticipated sales if our products and our licensors’ products do not receive regulatory approval.
We may encounter problems in the manufacture or supply of our products, for which we depend entirely on third parties. Strong competition exists in the sale of our promoted products, which could adversely affect expected growth of our promoted products’ sales or increase our costs to sell our promoted products. We may not be able to protect our competitive position for our promoted products from patent infringers. If generic competitors that compete with any of our products are introduced, our revenues may be adversely affected.
Certain of our products have experienced manufacturing issues. If the issues recur and cannot be resolved, our ability to acquire product for sale and sampling will be adversely affected. We may incur unexpected costs in integrating new products into our operations.
We may be unable to develop or market line extensions for our products or, even if developed, obtain patent protection for our line extensions; further, introductions by us of line extensions of our existing products may require that we make unexpected changes in our estimates for future product returns and reserves for obsolete inventory. If these risks occur, our financial results could be adversely affected.
If we have difficulties acquiring new products or rights to market new products from third parties, our financial results could be adversely impacted. Our licensor/supplier can terminate our rights to commercialize Nitrolingual and the 60mg dose size of this product has not yet met our expectation.
We may not experience the beneficial results of our acquisitions that we expect to receive, and the acquired products may not meet our sales expectations.
We depend on a small senior management group, the departure of any member of which would likely adversely affect our business if a suitable replacement member could not be retained.
An adverse interpretation or ruling by one of the taxing jurisdictions in which we operate could adversely impact our operating results. An adverse judgment in the pending patent litigation involving Prandin or in the securities class action litigation in which we and certain current and former directors and executive officers are defendants could have a material adverse effect on our financial results and liquidity.
Our business is subject to increasing government price controls and other healthcare cost containment measures. Side effects or marketing or manufacturing problems with our products could result in product liability claims which could be costly to defend and could result in the withdrawal or recall of products from the market which would adversely affect our business. We may be found noncompliant with applicable federal, state or international laws, rules or regulations which could result in fines and/or product recalls or otherwise cause us to expend significant resources to correct such non-compliance.
A small number of customers account for a large portion of our sales and the loss of one of them, or changes in their purchasing patterns, could result in substantially reduced sales, substantially and adversely impacting our financial results. If third-party payors do not adequately reimburse patients for our products, doctors may not prescribe them.
We rely on operational data obtained from IMS, an industry accepted data source. IMS data may not accurately reflect actual prescriptions (for instance, we believe IMS data does not capture all product prescriptions from some non-retail channels).
Our business and products are highly regulated; the regulatory status of some of our products makes these products subject to increased competition and other risks; and we run the risk that we, or third parties on whom we rely, could violate the governing regulations.
Some unforeseen difficulties may occur.
The above are some of the principal factors that could cause actual results to differ materially from those described in the forward-looking statements included above. These factors are not intended to represent a complete list of all risks and uncertainties inherent in our business, and should be read in conjunction with the more detailed cautionary statements and risk factors included in our other filings with the Securities and Exchange Commission.
Governor Otter Supports Food Barley Health Benefits and Economic Opportunity
LEWISTON, Idaho--(BUSINESS WIRE)--Governor C.L. “Butch” Otter, alongside BGLife™ Barley, the Idaho Barley Commission and Pacific Northwest Farmers Cooperative gathered today to announce food barley is an emerging economic opportunity for Idaho and the Pacific Northwest. BGLife Barley is a new high beta-glucan (fiber) food barley variety that promotes healthy blood sugar, is proven to reduce cholesterol, promotes healthy blood pressure and helps control weight, all conditions associated with diabetes and heart disease.
“The opportunities look tremendous for this new type of food barley, both for export as well as for largely untapped domestic markets,” said Governor Otter. “From my vantage point, BGLife Barley is a tremendous win for regional farmers who have new value-added markets, and for our consumers, particularly those with heart and diabetic risk factors.”
Overseas market demand created an opportunity for the Idaho Barley Commission to collaborate with Pacific Northwest Farmers Cooperative of Genesee, Idaho to export BGLife Barley. Other Asian markets such as Taiwan are also interested in BGLife Barley to help improve the fiber content of their rice-based diets. The domestic market potential is also growing as Americans become more aware of food barley’s health benefits.
BGLife Barley’s patented varieties are the result of almost 30 years of agricultural research. They are derived from a natural selection process focused on obtaining a superior nutritional profile and a high concentration of beta-glucan (soluble fiber). The FDA approved a heart health claim for food barley in 2006.
“As a company we have the responsibility and obligation to educate the public about the many benefits of food barley and how they can help battle factors associated with diabetes such as high cholesterol, high blood pressure, high blood sugar and obesity,” said Kevin Hodges, BGLife Barley Commercial Manager.
Type 2 diabetes poses one of the greatest health threats of the 21st century. According to the American Diabetes Association, 20.8 million Americans have diabetes; 6.2 million do not know they are afflicted, and 54 million Americans are pre-diabetic. Diabetes can be prevented with lifestyle interventions, such as eating a high-fiber diet and exercising regularly.
“Studies suggest that a healthy diet sufficient in soluble fiber beta-glucan from grain sources such as barley may help reduce the risk of Type 2 Diabetes,” said Frances Gough, M.D., co-founder and chief medical officer for Sound Health Solutions, a Redmond, Washington based weight and health risk management clinic.
More information is available at www.bglifebarley.com
“The opportunities look tremendous for this new type of food barley, both for export as well as for largely untapped domestic markets,” said Governor Otter. “From my vantage point, BGLife Barley is a tremendous win for regional farmers who have new value-added markets, and for our consumers, particularly those with heart and diabetic risk factors.”
Overseas market demand created an opportunity for the Idaho Barley Commission to collaborate with Pacific Northwest Farmers Cooperative of Genesee, Idaho to export BGLife Barley. Other Asian markets such as Taiwan are also interested in BGLife Barley to help improve the fiber content of their rice-based diets. The domestic market potential is also growing as Americans become more aware of food barley’s health benefits.
BGLife Barley’s patented varieties are the result of almost 30 years of agricultural research. They are derived from a natural selection process focused on obtaining a superior nutritional profile and a high concentration of beta-glucan (soluble fiber). The FDA approved a heart health claim for food barley in 2006.
“As a company we have the responsibility and obligation to educate the public about the many benefits of food barley and how they can help battle factors associated with diabetes such as high cholesterol, high blood pressure, high blood sugar and obesity,” said Kevin Hodges, BGLife Barley Commercial Manager.
Type 2 diabetes poses one of the greatest health threats of the 21st century. According to the American Diabetes Association, 20.8 million Americans have diabetes; 6.2 million do not know they are afflicted, and 54 million Americans are pre-diabetic. Diabetes can be prevented with lifestyle interventions, such as eating a high-fiber diet and exercising regularly.
“Studies suggest that a healthy diet sufficient in soluble fiber beta-glucan from grain sources such as barley may help reduce the risk of Type 2 Diabetes,” said Frances Gough, M.D., co-founder and chief medical officer for Sound Health Solutions, a Redmond, Washington based weight and health risk management clinic.
More information is available at www.bglifebarley.com
7/04/2008
Canava Café's New Ebook Offers Tips to Lose and Maintain Your Weight and Still Eat All Your Favorite Foods
Losing and maintaining your weight does not need to be boring or tiresome. Flavorful correct food combinations, fresh raw and cooked food ideas and a little creativity can spruce up meals and snacks. A new meal plan provides simple ways to keep losing or maintaining your weight interesting and enjoyable.
Doraville, GA June 14, 2008 -- The healthy eating experts at Canava Cafe, vegetarian catering, meal delivery, meal planning and personal chef services providing daily healthy eating plans based on proper food combination and 60-80% raw food diet, today announced the release of their 2nd ebook -- How To Maintain Your Perfect Weight And Still Eat Your Favorite Foods -- A quick guide to jump start your metabolism, controlling your weight and living a healthy fulfilling life without the pressure of being on a strict diet.
The eBook, written by healthy eating expert Monique M. Sharp, a vegetarian chef and author of 1st eBook -- Quick & Easy Vegetarian Recipes To Heal Your Body, explains some common weight loss myths and outlines how simple lifestyle changes and eating foods proven to make you healthy can help you control your weight and improve your overall health.
The eBook is free and available to download at http://easyvegetarian.blogspot.com/2007/02/quick-easy-healthy-vegetarian-recipes.html
Ms. Sharp is a long time healthy vegetarian eating expert. Based on the demands of his clients for healthy food, Ms. Sharp offers vegetarian cooking classes based on the proper food combination of cooked and raw food diet -- a diet bursting with flavor and which has been scientifically proven to lower the risk of many cancers and debilitating diseases. It is also a good diet to help lower cholesterol.
In the beginning, clients wanted the daily healthy eating plans with the taste and nutrition of the cooked and raw food diet, without the shopping, cooking or cleaning. So Ms. Sharp started preparing healthy frozen meals, offering a comprehensive daily eating meal plan solution for those wanting convenience of eating foods to make you healthy, lose weight, lower cholesterol, prevent disease and altogether promote living healthier lives. Based on high demand, clients wanted to learn how to prepare healthy vegetarian food for themselves. So Ms. Sharp started having vegetarian cooking classes in the clients home.
The Canava Cafe diet daily healthy eating plans consist of complete prepared raw and cooked meals, which includes organic raw fresh vegetables, lightly cooked vegetables, wholesome soups and salads delivered to consumer's home. Together, these Canava Cafe Diet meal plans contain the unique benefits of calorie controlled, low in saturated fat, low in sodium and nutritionally sound. There are four Canava Cafe diet daily healthy eating plans to choose from -- healthy living, diabetes, quick weight loss and 30 day weight loss. To learn more about the Canava Cafe diet meal plans or to sign up to have the delicious, prepared meals delivered to your home or office, visit http://canavacafe.com/weeklyfoodelivery.aspx or http://canavacafe.com/pcs.aspx.
About Canava Cafe
Canava Café, specializing in vegetarian catering, meal delivery, cooking classes and meal planning services providing daily healthy eating plans based on the Canava Café Diet, in Doraville, GA, is a family owned and operated business headed by healthy eating expert, Monique Sharp who is a 12 year raw vegan/vegetarian chef provided exquisite cuisine to the metro area of Atlanta, GA. Our strict quality control measures assure consistent flavors, textures, and appearance in each and every meal prepared. To learn more or to start having the Canava Cafe diet meal plans, private cooking classes, catering or delicious a la carte meals delivered to your home or office, visit http://www.canavacafe.com.
Doraville, GA June 14, 2008 -- The healthy eating experts at Canava Cafe, vegetarian catering, meal delivery, meal planning and personal chef services providing daily healthy eating plans based on proper food combination and 60-80% raw food diet, today announced the release of their 2nd ebook -- How To Maintain Your Perfect Weight And Still Eat Your Favorite Foods -- A quick guide to jump start your metabolism, controlling your weight and living a healthy fulfilling life without the pressure of being on a strict diet.
The eBook, written by healthy eating expert Monique M. Sharp, a vegetarian chef and author of 1st eBook -- Quick & Easy Vegetarian Recipes To Heal Your Body, explains some common weight loss myths and outlines how simple lifestyle changes and eating foods proven to make you healthy can help you control your weight and improve your overall health.
The eBook is free and available to download at http://easyvegetarian.blogspot.com/2007/02/quick-easy-healthy-vegetarian-recipes.html
Ms. Sharp is a long time healthy vegetarian eating expert. Based on the demands of his clients for healthy food, Ms. Sharp offers vegetarian cooking classes based on the proper food combination of cooked and raw food diet -- a diet bursting with flavor and which has been scientifically proven to lower the risk of many cancers and debilitating diseases. It is also a good diet to help lower cholesterol.
In the beginning, clients wanted the daily healthy eating plans with the taste and nutrition of the cooked and raw food diet, without the shopping, cooking or cleaning. So Ms. Sharp started preparing healthy frozen meals, offering a comprehensive daily eating meal plan solution for those wanting convenience of eating foods to make you healthy, lose weight, lower cholesterol, prevent disease and altogether promote living healthier lives. Based on high demand, clients wanted to learn how to prepare healthy vegetarian food for themselves. So Ms. Sharp started having vegetarian cooking classes in the clients home.
The Canava Cafe diet daily healthy eating plans consist of complete prepared raw and cooked meals, which includes organic raw fresh vegetables, lightly cooked vegetables, wholesome soups and salads delivered to consumer's home. Together, these Canava Cafe Diet meal plans contain the unique benefits of calorie controlled, low in saturated fat, low in sodium and nutritionally sound. There are four Canava Cafe diet daily healthy eating plans to choose from -- healthy living, diabetes, quick weight loss and 30 day weight loss. To learn more about the Canava Cafe diet meal plans or to sign up to have the delicious, prepared meals delivered to your home or office, visit http://canavacafe.com/weeklyfoodelivery.aspx or http://canavacafe.com/pcs.aspx.
About Canava Cafe
Canava Café, specializing in vegetarian catering, meal delivery, cooking classes and meal planning services providing daily healthy eating plans based on the Canava Café Diet, in Doraville, GA, is a family owned and operated business headed by healthy eating expert, Monique Sharp who is a 12 year raw vegan/vegetarian chef provided exquisite cuisine to the metro area of Atlanta, GA. Our strict quality control measures assure consistent flavors, textures, and appearance in each and every meal prepared. To learn more or to start having the Canava Cafe diet meal plans, private cooking classes, catering or delicious a la carte meals delivered to your home or office, visit http://www.canavacafe.com.
The Secret of Getting Hundred of Low Carb Recipes for Free
The site www.low-carb-diet-recipes.com is an excellent site to find important information regarding how low carb diets can help in weight management, control diabetes and maintain good health. The site thoroughly explains advantages of a low carb diet, how the diet works, and what problems have caused over 60% of Americans to be obese.
Ferndale, WA (PRWEB) June 18, 2008 -- Low-Carb-Diet-Recipes.com (http://www.low-carb-diet-recipes.com) has vital information for users interested in becoming healthier. On the right hand side of the homepage there is an extremely efficient topics section which consists of over 200 low carb recipes, explanations on what a low carb diet is, how it works, the type of lifestyle for which a low carb diet would not work for, and an easy to use low carb diet forum where users can discuss their experiences. Each of these sections explains the topic in depth and gives the reader all the information that is necessary for them to understand how a low carb diet works and how it can help improve their health.
One of the great advantages of the site is that it serves multiple purposes. Not only can the user find important information regarding why to use a low carb diet and how it can help them, but it also lets the user view over 240 delicious low carb recipes. The recipes are all easy to make and taste just the same if not better than a meal that is packed with carbs. These recipes are well organized into groups such as main dishes, side dishes, snacks/soups and more, which help users find the recipes that suit them best.
The site (http://www.low-carb-diet-recipes.com) not only advises you on what kinds of foods are healthy to eat, but it takes it a step further by making an easy to use seven day meal plan. The meal plan features delicious breakfasts, lunches, dinners, and snacks for all seven days of the week. The dishes included in these meals are easy to make and are healthy meals that will help users lose weight, control their diabetes if necessary, and remain healthy.
www.low-carb-diet-recipes.com is the number one place to learn about the factors that cause low carb diets to be successful;, how to make hundreds of low carb, appetizing meals, and plenty more.
Ferndale, WA (PRWEB) June 18, 2008 -- Low-Carb-Diet-Recipes.com (http://www.low-carb-diet-recipes.com) has vital information for users interested in becoming healthier. On the right hand side of the homepage there is an extremely efficient topics section which consists of over 200 low carb recipes, explanations on what a low carb diet is, how it works, the type of lifestyle for which a low carb diet would not work for, and an easy to use low carb diet forum where users can discuss their experiences. Each of these sections explains the topic in depth and gives the reader all the information that is necessary for them to understand how a low carb diet works and how it can help improve their health.
One of the great advantages of the site is that it serves multiple purposes. Not only can the user find important information regarding why to use a low carb diet and how it can help them, but it also lets the user view over 240 delicious low carb recipes. The recipes are all easy to make and taste just the same if not better than a meal that is packed with carbs. These recipes are well organized into groups such as main dishes, side dishes, snacks/soups and more, which help users find the recipes that suit them best.
The site (http://www.low-carb-diet-recipes.com) not only advises you on what kinds of foods are healthy to eat, but it takes it a step further by making an easy to use seven day meal plan. The meal plan features delicious breakfasts, lunches, dinners, and snacks for all seven days of the week. The dishes included in these meals are easy to make and are healthy meals that will help users lose weight, control their diabetes if necessary, and remain healthy.
www.low-carb-diet-recipes.com is the number one place to learn about the factors that cause low carb diets to be successful;, how to make hundreds of low carb, appetizing meals, and plenty more.
The Signs Of Hypoglycemia
Glucose is the body's fuel. Our brains require it to function properly and our muscles require it to move. It is the food for all of our cells. Therefore, it is important to maintain normal blood glucose levels for our bodies to function properly.
A normal blood sugar level is between 60-100 mg/dl. Your level raises some after a meal and it is lower in the morning when you first awaken. But your blood sugar level should never go below 60 mg/dl if you are not a diabetic. If you have a problem with your blood sugar dropping, commonly called hypoglycemia, you should see your doctor.
Hypoglycemia can be caused by many different things. Most cases of hypoglycemia will occur in people who has diabetes. If a diabetic has a decreased appetite or skips a meal and does not adjust their insulin or oral diabetic medicine to compensate, they will have a drop in glucose. But there are other conditions that can cause hypoglycemia also. Let's look at a few of them.
Cancer can be a cause of low blood sugar. Chemotherapy will decrease the appetite or lead to nausea and vomiting. Food does not taste the same to people who have had chemotherapy. Skipping meals or eating very little will cause a drop in blood sugar levels.
Excessive alcohol consumption can stop your body from producing glucose which causes your body to use up all of its stored glycogen. This will only occur if you are drinking very heavily and have had nothing to eat.
Liver disease can cause low blood sugar because the liver is a key organ in glucose production. The kidney is also an important organ in glucose production and conditions such as kidney failure will cause hypoglycemia.
A beta cell tumor of the pancreas, called insulinoma, can cause hypoglycemia by causing an overproduction of insulin. Insulin is what controls the amount of glucose in your blood and too much insulin will cause a drop in blood glucose.
Endocrine deficiencies will cause hypoglycemia. The endocrine system is a network of glands that produce hormones that regulate processes throughout the body. These glands are the pituitary gland, thyroid gland, parathyroid gland, the adrenal glands, the pancreas, ovaries and testicles. Certain disorders of the adrenal glands or the pituitary gland can interfere with glucose production and cause hypoglycemia.
It is important to recognize the signs and symptoms of hypoglycemia. These symptoms may include:
* Confusion or abnormal behavior
* Visual disturbances, such as double vision or blurred vision
* Occasionally seizures
* Loss of consciousness
* Heart palpitations
* Shaking
* Anxiety
* Sweating
* Hunger
If you think someone is having a hypoglycemic episode, it is important to call for help and try to raise their blood sugar as fast as possible. Brain and organ damage can result if their level drops too low for any amount of time. If they are still awake and able to drink, have them drink a glass of juice. It will help if you can add some sugar packets to it. If they are unconscious or bordering on becoming unconscious, get some sugar and place it under their tongue. This area is highly vascular and the sugar will absorb into the bloodstream fast.
Low blood sugar is not for diabetics only. It can happen to almost anyone at anytime without warning.
A normal blood sugar level is between 60-100 mg/dl. Your level raises some after a meal and it is lower in the morning when you first awaken. But your blood sugar level should never go below 60 mg/dl if you are not a diabetic. If you have a problem with your blood sugar dropping, commonly called hypoglycemia, you should see your doctor.
Hypoglycemia can be caused by many different things. Most cases of hypoglycemia will occur in people who has diabetes. If a diabetic has a decreased appetite or skips a meal and does not adjust their insulin or oral diabetic medicine to compensate, they will have a drop in glucose. But there are other conditions that can cause hypoglycemia also. Let's look at a few of them.
Cancer can be a cause of low blood sugar. Chemotherapy will decrease the appetite or lead to nausea and vomiting. Food does not taste the same to people who have had chemotherapy. Skipping meals or eating very little will cause a drop in blood sugar levels.
Excessive alcohol consumption can stop your body from producing glucose which causes your body to use up all of its stored glycogen. This will only occur if you are drinking very heavily and have had nothing to eat.
Liver disease can cause low blood sugar because the liver is a key organ in glucose production. The kidney is also an important organ in glucose production and conditions such as kidney failure will cause hypoglycemia.
A beta cell tumor of the pancreas, called insulinoma, can cause hypoglycemia by causing an overproduction of insulin. Insulin is what controls the amount of glucose in your blood and too much insulin will cause a drop in blood glucose.
Endocrine deficiencies will cause hypoglycemia. The endocrine system is a network of glands that produce hormones that regulate processes throughout the body. These glands are the pituitary gland, thyroid gland, parathyroid gland, the adrenal glands, the pancreas, ovaries and testicles. Certain disorders of the adrenal glands or the pituitary gland can interfere with glucose production and cause hypoglycemia.
It is important to recognize the signs and symptoms of hypoglycemia. These symptoms may include:
* Confusion or abnormal behavior
* Visual disturbances, such as double vision or blurred vision
* Occasionally seizures
* Loss of consciousness
* Heart palpitations
* Shaking
* Anxiety
* Sweating
* Hunger
If you think someone is having a hypoglycemic episode, it is important to call for help and try to raise their blood sugar as fast as possible. Brain and organ damage can result if their level drops too low for any amount of time. If they are still awake and able to drink, have them drink a glass of juice. It will help if you can add some sugar packets to it. If they are unconscious or bordering on becoming unconscious, get some sugar and place it under their tongue. This area is highly vascular and the sugar will absorb into the bloodstream fast.
Low blood sugar is not for diabetics only. It can happen to almost anyone at anytime without warning.
New Diabetic Treatment
Even though bones seem to be metabolically inactive structures, nothing could be further from the truth. In fact, bones are rebuilt constantly through the action of cells known as osteoblasts while old bone is destroyed by other cells known as osteoclasts. Bones also produce red and white blood cells, help maintain blood pH and store calcium. However, exciting new research has shown that bones also act as an endocrine organ. Not only do bones produce a protein hormone, osteocalcin, that regulates bone formation, but this hormone also protects against obesity and glucose intolerance by increasing proliferation of pancreatic beta cells and their subsequent secretion of insulin.
Osteocalcin was also found to increase the body's sensitivity to insulin and as well as reducing its fat stores.
Hormones function as chemical messengers that allow the body to precisely coordinate metabolism, reproduction and other essential biological processes that involve multiple organs.
"The skeleton used to be thought of as just a structural support system. This opens the door to a new way of seeing the bones," said Dr. Gerard Karsenty, chairman of the department of genetics and development at Columbia University Medical Center in NYC, who headed the team that made the discovery.
Additionally, it was known that people with untreated type 2 diabetes have low osteocalcin levels, which made this hormone an appealing target for their research efforts.
To do this research, the scientists designed an elegant series of experiments using several groups of mice. The first group of experimental mice had their osteoblast gene, called Esp, genetically deactivated, or "knocked out". Esp encodes a receptor-like protein tyrosine phosphatase called OST-PTP that increases beta-cell proliferation and insulin secretion in the pancreas, which results in hypoglycemia. But these so called "knock-out mice" lacked all functional Esp genes, so their insulin secretion and sensitivity decreased causing them to become obese and then to develop Type 2 diabetes when fed a normal diet. Type 2 diabetes occurs when the body becomes resistant to insulin, the hormone that regulates sugar metabolism.
A second group of experimental mice were genetically engineered to over-produce osteocalcin. These mice showed lower-than-normal blood glucose levels and higher insulin levels than did normal mice that were fed a normal diet. Additionally, these "overproducer mice" also showed increased insulin sensitivity. This is probably the most exciting result because typically, excess blood insulin decreases tissues' sensitivity to the hormone, which makes insulin treatment difficult for diabetics. Further, the team found that treating the "knock-out mice" with osteocalcin helped regulate their blood sugar and insulin.
Additionally, the investigators reported that mice with one functional copy of Esp showed a significant reversal of their metabolic abnormalities, which provides "genetic evidence that Esp and osteocalcin lie in the same regulatory pathway and that [the] Esp-/- mice metabolic phenotype is caused by a gain-of-activity of this hormone."
Interestingly, mice that are genetically programmed to overeat and mice that were fed fatty diets were prevented from suffering both obesity and diabetes when given high levels of osteocalcin. Karsenty is now determining whether giving osteocalcin to his diabetic "knock-out mice" will reverse the disease. This research shows promise for treating human diabetics as well.
Finding a substance that increases beta cell proliferation, says Karsenty, "is a holy grail for diabetes research."
Osteocalcin was also found to increase the body's sensitivity to insulin and as well as reducing its fat stores.
Hormones function as chemical messengers that allow the body to precisely coordinate metabolism, reproduction and other essential biological processes that involve multiple organs.
"The skeleton used to be thought of as just a structural support system. This opens the door to a new way of seeing the bones," said Dr. Gerard Karsenty, chairman of the department of genetics and development at Columbia University Medical Center in NYC, who headed the team that made the discovery.
Additionally, it was known that people with untreated type 2 diabetes have low osteocalcin levels, which made this hormone an appealing target for their research efforts.
To do this research, the scientists designed an elegant series of experiments using several groups of mice. The first group of experimental mice had their osteoblast gene, called Esp, genetically deactivated, or "knocked out". Esp encodes a receptor-like protein tyrosine phosphatase called OST-PTP that increases beta-cell proliferation and insulin secretion in the pancreas, which results in hypoglycemia. But these so called "knock-out mice" lacked all functional Esp genes, so their insulin secretion and sensitivity decreased causing them to become obese and then to develop Type 2 diabetes when fed a normal diet. Type 2 diabetes occurs when the body becomes resistant to insulin, the hormone that regulates sugar metabolism.
A second group of experimental mice were genetically engineered to over-produce osteocalcin. These mice showed lower-than-normal blood glucose levels and higher insulin levels than did normal mice that were fed a normal diet. Additionally, these "overproducer mice" also showed increased insulin sensitivity. This is probably the most exciting result because typically, excess blood insulin decreases tissues' sensitivity to the hormone, which makes insulin treatment difficult for diabetics. Further, the team found that treating the "knock-out mice" with osteocalcin helped regulate their blood sugar and insulin.
Additionally, the investigators reported that mice with one functional copy of Esp showed a significant reversal of their metabolic abnormalities, which provides "genetic evidence that Esp and osteocalcin lie in the same regulatory pathway and that [the] Esp-/- mice metabolic phenotype is caused by a gain-of-activity of this hormone."
Interestingly, mice that are genetically programmed to overeat and mice that were fed fatty diets were prevented from suffering both obesity and diabetes when given high levels of osteocalcin. Karsenty is now determining whether giving osteocalcin to his diabetic "knock-out mice" will reverse the disease. This research shows promise for treating human diabetics as well.
Finding a substance that increases beta cell proliferation, says Karsenty, "is a holy grail for diabetes research."
7/02/2008
Pre Diabetes Symptoms
Pre diabetes is a condition wherein no physical symptoms are seen although you are predisposed to having diabetes because of the risk factors that are present like having a history of diabetes in the family, age, sedentary lifestyle, obesity, insulin resistance, smoking, alcoholic abuse and an unhealthy lifestyle. Insulin resistance, the cause of pre-diabetes initiates a disparity between glucose and insulin levels in the blood. If it is not treated, it will eventually lead to type-2 diabetes which does not have a treatment, only management, possibly requiring daily insulin injections to maintain blood glucose in normal levels.
Pre diabetes symptoms are mainly due to obesity. Almost everyone suffering from this condition first has pre diabetes, meaning their blood glucose levels are higher than a normal individual but have not yet reached the range of type 2 diabetics. General causes of pre diabetes are resistance to insulin and being overweight, which can generally be corrected by changing to a balanced regular exercise a nutritious diet and support to encourage healthier lifestyle changes.
Being overweight is the main cause of insulin resistance which causes the development of pre diabetes. Reversing the effects of insulin resistance is important in preventing the occurrence of type 2 Diabetes and the risk of having cardiovascular problems. Insulin is the hormone produced by the pancreas that breaks down glucose to facilitate its entry into the cell and be converted into energy. Being insulin resistant means that the cells react slowly to insulin, thus lowering the rate in which glucose is utilized and in turn increasing the glucose in the blood leading to pre diabetes. The links between insulin resistance, obesity and pre diabetes are complicated. Insulin resistance leads to obesity and causes pre diabetes while obesity makes insulin resistance worse; when insulin resistance gets worse, this consequently enhances the development of pre-diabetes. Pre diabetes is the precursor of type 2 or juvenile diabetes. There is no single solution that can treat all the symptoms of insulin resistance and pre diabetes. Regular exercise increases the amount of insulin receptors on the cells thus more glucose can enter the cell and boost your energy. Muscles use up glucose for its energy, thus balancing glucose levels with insulin.
A diet with low carbohydrate is effective in losing weight and controls insulin production in the pancreas. Keeping a low GI, the less likely it is to increase blood glucose levels after meals. Cortisol is also increased, with a change in blood sugar and thus increasing insulin.
Other conditions and symptoms like high blood pressure and high cholesterol levels that may arise because of pre diabetes should be consulted with a doctor or your health care provider. They should be treated with medications until weight is controlled and lowered to normal levels. As soon as the diet affects insulin production into normal, cholesterol and blood pressure will also normalize.
Pre diabetes symptoms are mainly due to obesity. Almost everyone suffering from this condition first has pre diabetes, meaning their blood glucose levels are higher than a normal individual but have not yet reached the range of type 2 diabetics. General causes of pre diabetes are resistance to insulin and being overweight, which can generally be corrected by changing to a balanced regular exercise a nutritious diet and support to encourage healthier lifestyle changes.
Being overweight is the main cause of insulin resistance which causes the development of pre diabetes. Reversing the effects of insulin resistance is important in preventing the occurrence of type 2 Diabetes and the risk of having cardiovascular problems. Insulin is the hormone produced by the pancreas that breaks down glucose to facilitate its entry into the cell and be converted into energy. Being insulin resistant means that the cells react slowly to insulin, thus lowering the rate in which glucose is utilized and in turn increasing the glucose in the blood leading to pre diabetes. The links between insulin resistance, obesity and pre diabetes are complicated. Insulin resistance leads to obesity and causes pre diabetes while obesity makes insulin resistance worse; when insulin resistance gets worse, this consequently enhances the development of pre-diabetes. Pre diabetes is the precursor of type 2 or juvenile diabetes. There is no single solution that can treat all the symptoms of insulin resistance and pre diabetes. Regular exercise increases the amount of insulin receptors on the cells thus more glucose can enter the cell and boost your energy. Muscles use up glucose for its energy, thus balancing glucose levels with insulin.
A diet with low carbohydrate is effective in losing weight and controls insulin production in the pancreas. Keeping a low GI, the less likely it is to increase blood glucose levels after meals. Cortisol is also increased, with a change in blood sugar and thus increasing insulin.
Other conditions and symptoms like high blood pressure and high cholesterol levels that may arise because of pre diabetes should be consulted with a doctor or your health care provider. They should be treated with medications until weight is controlled and lowered to normal levels. As soon as the diet affects insulin production into normal, cholesterol and blood pressure will also normalize.
Diabetes Glucose Test
To determine if a patient has onset or even a high risk for diabetes, a doctor will typically order and perform a diabetes diagnostic test. A diabetes glucose test is one of many tests and considerations a medical team will examine to determine if you are at risk for the symptoms of diabetes. There are a number of different methods to apply a diabetes glucose test, the most common being a fasting plasma glucose test (FPG) or an oral glucose tolerance test (OGTT).
Usually, a diabetes diagnostic test follows eight hours of fasting, as with fasting plasma glucose (FPG) test or an oral glucose tolerance test (OGTT). The FPG test is the preferred diabetes diagnostic test, and if it returns a positive result, should be followed in a few days with another FPG test to confirm the condition of pre-diabetes or onset diabetes.
The OGTT is a more sensitive test and therefore often considered a better diabetes diagnostic test to identify the existence of a pre-diabetes condition. The OGTT is a diabetes diagnostic test that involves eight hours of fasting with a glucose level check before and up to two hours following the drinking of a liquid containing a specific amount of glucose dissolved in water. An OGTT is also used as a specific diabetes diagnostic test to help identify gestational diabetes, and as with the FPG test, specific results in an OGTT must be repeated in a later test to confirm a diagnosis.
If any indication of diabetes or pre-diabetes is reached during these tests, your doctor may request that you more closely monitor your blood glucose levels with a daily or repeated diabetes glucose test performed at home, ensuring no sudden changes in your blood glucose levels. Though a diabetes glucose test is considered by most experts to be an accurate evaluation of any existing or emerging condition, other factors are also considered before making a clear diagnosis. Your medical history, presence or absence of symptoms, and even any recent illnesses are taken into account with the diabetes glucose test to make sure that your levels are not transient or fluctuating due to specific situations.
Most every diabetes glucose test is a painless procedure that is common in any endocrinologist’s office, and with an early diagnosis and proper attention to diet, exercise and medication, you will be able to live as long, happy life free from the symptoms of onset diabetes.
Usually, a diabetes diagnostic test follows eight hours of fasting, as with fasting plasma glucose (FPG) test or an oral glucose tolerance test (OGTT). The FPG test is the preferred diabetes diagnostic test, and if it returns a positive result, should be followed in a few days with another FPG test to confirm the condition of pre-diabetes or onset diabetes.
The OGTT is a more sensitive test and therefore often considered a better diabetes diagnostic test to identify the existence of a pre-diabetes condition. The OGTT is a diabetes diagnostic test that involves eight hours of fasting with a glucose level check before and up to two hours following the drinking of a liquid containing a specific amount of glucose dissolved in water. An OGTT is also used as a specific diabetes diagnostic test to help identify gestational diabetes, and as with the FPG test, specific results in an OGTT must be repeated in a later test to confirm a diagnosis.
If any indication of diabetes or pre-diabetes is reached during these tests, your doctor may request that you more closely monitor your blood glucose levels with a daily or repeated diabetes glucose test performed at home, ensuring no sudden changes in your blood glucose levels. Though a diabetes glucose test is considered by most experts to be an accurate evaluation of any existing or emerging condition, other factors are also considered before making a clear diagnosis. Your medical history, presence or absence of symptoms, and even any recent illnesses are taken into account with the diabetes glucose test to make sure that your levels are not transient or fluctuating due to specific situations.
Most every diabetes glucose test is a painless procedure that is common in any endocrinologist’s office, and with an early diagnosis and proper attention to diet, exercise and medication, you will be able to live as long, happy life free from the symptoms of onset diabetes.
Diabetic Diets And Wine
Belief in the medicinal value of wine is as old as wine itself. The deep, beautiful purple-red color of red wine is produced by a substance called anthocyanin, which is found in the skin of the grape. In addition to the color of red wine, we can thank anthocyanins for the deep red-purple-black color of black olives; and the berry-red color of strawberries, cherries, and raspberries.
The Mediterranean wine is considered very essential in meals and health. An important study of over 40,000 people showed that compared to more modern western diets, a traditional Mediterranean Diet which included 1-2 glasses of wine a day reduced the danger of death by heart disease by 30%.
Unfortunately, for people with diabetes a simple glass of wine or beer doesn't appear in most diabetic diets.
People with diabetes are agreed that the elevated levels of blood sugar is dangerous for them so diabetic diets are geared towards managing blood glucose levels. Actual studies have shown that drinking a reasonable amount of wine daily (1-2 glasses) can lower blood glucose. In a different study, women improved the insulin resistance just for adding moderate consumption of wine to her diets. We all know that high peak levels of insulin are dangerous to people with diabetes since they can lift blood fat and cholesterol increasing the risk of heart attacks and heart illness.
One of the greatest benefits of wine is its capacity to decrease the risks of heart disease, heart attacks and other heart-health issues because it increase levels of "good" HDL-cholesterol in the body. In addition, the flavonoids found in red wine help lower levels of "bad" LDL-cholesterol which are responsible for fatty buildup in the arteries. That is the beneficial part that wine have for people with diabetes and if they complement it with health diets, they can consider themselves as winners. As a complement we can say that a new study confirm that drinking 1-2 glasses of wine a day reduced the danger of coronary heart disease by 60% for people with diabetes compared to a drop of only 40% for people without diabetes.
Red wine may also reduce oxidative stress caused by increased blood glucose levels after meals, according to Antonio Ceriello, MD, and associates. In a research letter published in the December 1999 issue of Diabetes Care, Dr. Ceriello and associates presented data showing that consumption of two 5-ounce glasses of red wine with a meal by subjects with type 2 diabetes significantly reduced the compounds produced by the test meal that could cause vascular damage by the mechanism of "oxidative stress." The protective activity of white wine was only about 20 percent that of red wine.
It only takes adding 1-2 glasses a day to most diabetic diets to grow the health benefits of alcohol outlined above.
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