GlaxoSmithKline Presents Avandia Data To FDA

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PHILADELPHIA, July 30 /-/ -- 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.
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