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The Philippine office of GlaxoSmithKline said that the multinational drug firm strongly disagrees with the findings of an article published in the New England Journal of Medicine (NEJM) that says their widely used and highly effective treatment for type 2 diabetes, Avandia (rosiglitazone maleate), exposed one to significant risk of heart attacks and death from cardiovascular causes.

GSK said the NEJM article on Avandia was based on an analysis of summary information that combines a number of studies, or a meta-analysis, which they said was not the most rigorous way to reach definite conclusions about adverse events.

“Each study is designed differently and looks at unique questions. For example, individual studies vary in size and length, in the type of patients who participated, and in the outcomes they investigate. The data compiled from these varied studies are complex and can be conflicting,” GSK said in a press statement.

GSK explained that the most scientifically rigorous way to examine the safety and benefits of a medicine is to conduct large-scale, long-term clinical trials in patients with the disease.

“Several trials of this type have been ongoing for many years. To date, concerns regarding patient safety have not been identified by the independent Safety Monitoring Boards for these trials. Several trials have completed and the results published,” GSK said.

GSK cited the example of their long-term, landmark study ADOPT (A Diabetes Outcome Progression Trial), said to be one of the longest clinical trials in people with type 2 diabetes to date, which directly compared both the safety and effectiveness of Avandia with other oral anti-diabetic medicines in over 4,300 patients studied for up to six years.

Data from ADOPT showed that the overall risk of serious, cardiovascular events (CV death, myocardial infarction, and stroke, or MACE endpoint) for patients on Avandia was comparable to metformin and sulfonylurea (glyburide), two of the most commonly used medicines to treat type 2 diabetes.

ADOPT showed comparable rates of cardiovascular deaths: Avandia (five reports out of 1,456 patients, or 0.34 percent), Metformin, four out of 1,454 or 0.28 percent), and Glyburide (eight out of 1,441 or 0.56 percent).

The ADOPT clinical trial did show a small increase in reports of myocardial infarction among the Avandia-treated group (Avandia: 24 out of 1,456 or 1.65 percent) as against those taking Metformin (20 out of 1,454 or 1.38 percent) or Glyburide (14 out of 1,441 or 0.97 percent).

However, the number of events is too small to reach a reliable conclusion about the role any of the medicines may have played in this finding.