PHILADELPHIA, July 30 /PRNewswire-FirstCall/ -- The following
summarizes GlaxoSmithKline's [NYSE: GSK] presentation of data on Avandia(R)
(rosiglitazone maleate) to an Advisory Committee of the Food and Drug
Administration (FDA) on July 30, 2007.
The GSK presentation demonstrates the weight of scientific evidence
available to address a question of increased risk of cardiovascular
ischemic events. This question was raised by different meta-analyses
performed by GSK, the FDA and one published in the NEJM. Although a
meta-analysis can help raise scientific questions for further
investigation, such analyses can also have significant limitations. GSK
believes a full and scientific evaluation of all the data does not confirm
the safety questions originally raised.
Long-term clinical trials -- particularly those designed to test a
specific outcome in patients with the disease -- are the most robust tools
available to answer questions raised by meta-analyses. A 1997 published
review of meta-analyses revealed 33% of the conclusions of meta-analyses
are not confirmed by subsequent clinical trials.
Avandia is the most widely studied oral anti-diabetic medicine for the
treatment of type 2 diabetes. The extensive data for Avandia includes:
-- 116 clinical trials in over 52,000 patients. These include:
-- Three, long-term clinical trials in more than 14,000 patients:
ADOPT, DREAM, RECORD, with RECORD specifically studying
cardiovascular effects
-- A study in a high cardiovascular-risk population: PPAR
-- Three epidemiological studies reflecting real life use of diabetes
medicines in more than 1.3 million diabetic patients.
Additionally, four other ongoing long-term studies will increase
available data on the cardiovascular safety of Avandia: BARI-2D, ACCORD,
VADT, APPROACH.
Across the extensive dataset for Avandia, there is no consistent or
systematic evidence that Avandia increases the risk of heart attack or
cardiovascular death in comparison to other anti-diabetic medicines.
Specifically:
-- Myocardial ischemia: There was no statistically significant increase in
myocardial ischemia in ADOPT, GSK's long-term comparator study.
-- Heart attack: The number of heart attacks across all sources of data
is small, the data are inconsistent, and the totality of the evidence
does not show a difference between Avandia and the most commonly
prescribed anti-diabetic agents. In three epidemiological database
studies, the risk of heart attack was similar for Avandia compared to
other anti-diabetic agents, and in the one database study comparing
Avandia to Actos, there was no difference.
-- CV death: The long-term trials provide no evidence of increased CV
death or all cause mortality with Avandia compared to the most commonly
prescribed oral anti-diabetics.
-- Stroke: Across the data sources, fewer strokes are observed with
Avandia than with other anti-diabetic medicines, although the
differences in the long-term trials were not statistically significant.
Importantly, in the ADOPT study, Avandia has been shown to control
blood sugar for longer than the most commonly used oral anti-diabetic
medicines. Avandia is an important treatment option for physicians since
diabetes worsens over time, and half of the patients treated today are on
combination therapy. Controlling blood sugar has been shown in the UKPDS
studies to be important in reducing the risk of serious complications of
diabetes, such as blindness, renal problems, amputations and heart attack.
GSK continues to support Avandia as safe and effective when used
appropriately.
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. It may be taken alone or with other diabetes medicines. For some
people taking Avandia, possible side effects include heart failure or other
heart problems. Further information regarding potential heart-related risks
is currently under review by the FDA. Talk to your doctor as FDA has made
information on potential heart-related risks available to physicians on its
website at http://www.fda.gov . Tell your doctor if you have heart problems
or heart failure. Avandia can cause your body to keep extra fluid, which
leads to swelling and weight gain. Extra body fluid can make some heart
problems worse or lead to heart failure. If you have swelling or fluid
retention, shortness of breath or trouble breathing, an unusually rapid
increase in weight, or unusual tiredness while taking Avandia, call your
doctor right away. You should not take Avandia if you have liver problems.
Blood tests should be used to check for liver problems before starting and
while taking Avandia. Tell your doctor if you have liver disease, or if you
experience unexplained tiredness, stomach problems, dark urine or yellowing
of skin while taking Avandia. Tell your doctor about all of the medicines
you are taking. If you are taking Avandia with another diabetes medicine
that lowers blood sugar, you may be at increased risk for low blood sugar.
Ask your doctor whether you need to lower the dose of your other diabetes
medicine. Avandia may increase your risk of pregnancy. Talk to your doctor
before taking Avandia if you could become pregnant or if you are pregnant.
If you are nursing, you should not take Avandia. Talk to your doctor for
advice on how to keep your bones healthy. More fractures, usually in the
upper arm, hand, or foot, have been seen in women taking Avandia. Your
doctor should check your eyes regularly. Very rarely, some people have
experienced vision changes due to swelling in the back of the eye while
taking Avandia.
SOURCE GlaxoSmithKline
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