The Rosiglitazone ( Avandia ) Debate (Medical Horizons)

Aly A. Misha'l


On May 21st, 2007 the New England Journal of Medicine (NJEM) posted a very disturbing report on its website, written by Dr. Nissen, head of Cardiovascular Medicine at the Cleveland Clinic, which revealed that Rosiglitazone was associated with a significantly increased risk of myocardial infarctions and possible death from cardiovascular causes. These findings were subsequently published in June 2007 in the same journal, and stirred a furor among physicians and patients all over the world.

The authors admitted that their study suffered from limitations because of their lack of access to original source data, which would have provided more meaningful time – to – event analysis.

This study was a meta-analysis of 42 studies, which, according to the authors, fulfilled their inclusion criteria, out of 116 studies.

Rosiglitazone (Avandia) is a well-known anti-diabetes medication manufactured by GlaxoSmithKline (GSK) company. In 2006 alone, 11 million patients used it in USA alone, with profit to GSK exceeding 3 billion dollars.
Many physicians were satisfied with this drug which is used as a long acting pill form and results in significant improvement of glycemic control, despite a number of risks described in its label, which include fluid retension, weight gain and macular edema. Last year, GSK quietly added another risk: potential heart attacks.

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