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GlaxoSmithKline Responds to JAMA Articles

PHILADELPHIA, Sept. 11 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) believes that conclusions drawn from the most recent meta-analyses published by Drs. Nissen et. al. and Furberg et. al. in the Journal of the American Medical Association (JAMA) do not confirm a difference in the safety profile of Avandia(R) (rosiglitazone) and Actos(R) (pioglitazone). These analyses reflect limitations that are common to all meta-analyses, by the authors' own admission. These analyses do not yield data robust enough to guide doctors in selecting appropriate diabetes treatments for their patients. Comparisons between different meta-analyses with different endpoints and patient populations are even more unreliable.

The Actos meta-analysis is based on a small number of studies (19) provided directly by Takeda, and is heavily biased by data from the PROactive study (5,238 patients) which contributed 80 percent of the endpoint data. The patient population in the PROactive study was at high risk of cardiovascular disease.

-- PROactive compared diabetic patients on Actos to those on placebo.

Patients taking Actos to control blood sugar might be expected to have

fewer cardiovascular events than those who were not controlled on

medication, consistent with the primary results of PROactive (Hazard

Ratio 0.90 p=0.095). However, as described by FDA in the recent

Advisory Committee, at six months PROactive actually showed an

increased risk of heart attack (HR 1.2).

-- Applying the endpoint of CV death, myocardial infarction and stroke to

the data on Avandia across long-term clinical trials to enable a closer

like-for-like comparison with the Actos meta-analysis shows no

statistical difference between Avandia and comparators (a hazard ratio

of 1.03). In RECORD, a study specifically designed to look at

cardiovascular events, no real difference was seen between Avandia and

comparators (HR 0.96). In all of these analyses, the Avandia and the

Actos hazard ratios (HR 0.82 for Actos in Nissen meta-analysis) do not

suggest an increased risk versus the comparators.

-- No long-term, head-to-head clinical trial data specifically evaluates

cardiovascular risk between Avandia and Actos; however, the

head-to-head data that does exist, and the overwhelming majority of

comparative observational data, show no significant differences in CV


The JAMA article on Avandia is yet another iteration of previously analyzed data, and offers no new information on the safety of Avandia. The suggested increase in heart attack cited comes from a selective re-analyses of previously published and highly selective data from only four of 116 available studies, and reflects a difference of only 11 events in 14,291 patients between Avandia and control. In this limited meta-analysis, in the context of all the other evidence, we believe it is inappropriate for the author to advise doctors to disregard the FDA's advice which is to keep patients who are effectively controlling their diabetes on Avandia. These data have been presented to an expert advisory panel of the FDA, which voted to keep Avandia available to patients -- a vote that reflects the role of this medicine as an important treatment option to help diabetes patients control their blood sugar.

The conclusions of these meta-analyses conflict with the wealth of accumulated data on Avandia -- including 116 clinical trials in more than 52,000 patients and epidemiological studies of databases in over 1 million patients. Analyzed studies show no difference in the ischemic cardiovascular effects of Avandia versus other oral anti-diabetic medicines, including Actos.

1. Across this extensive data set, the number of heart attacks is small,

and Avandia is shown to have a comparable cardiovascular profile to the

two most prescribed oral anti-diabetic medicines -- metformin and

sulfonylurea -- apart from the well characterized fluid-related events

common to both Avandia and Actos.

2. In three epidemiological studies of databases with more than one

million diabetic patients, the risk of heart attack was similar for

Avandia compared to other anti-diabetic agents. A database study

comparing Avandia to Actos showed no difference between the two.

3. Two large epidemiology studies presented to the FDA Advisory Committee

and conducted independently of GSK by WellPoint and by the Department

of Defense/Tricare also showed no increased rates of heart attack

between Avandia and Actos.

Importantly, only Avandia has been shown to control blood sugar for up to five years and to be 32 percent more effective than metformin and 63 percent more effective than sulfonylurea in maintaining blood sugar control over the long-term. We know from clinical studies that effective treatment of diabetes requires intensive, long-term, day-to-day control of blood sugar levels to reduce the risk of serious complications (e.g., blindness, kidney failure, limb amputation, nerve injury) and ultimately save lives. Avandia is the most widely studied oral medication for Type 2 Diabetes, and is an important option for physicians who often need to prescribe several different diabetes medicines in combination to help their patients maintain blood sugar control.

The FDA is engaged in a full, objective analysis of the science, and will make its independent recommendations on the appropriate use of oral anti- diabetic medicines. GSK continues to support Avandia as safe and effective when used appropriately.

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 .

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. Certain people with heart failure should not take Avandia. Tell your doctor if you have heart problems or heart failure. Avandia can cause heart failure. Avandia can also 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. For some people taking Avandia, possible side effects include 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 . 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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