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