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Avandia — FDA to Evaluate Heart Disease Risk

07/13/2010
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At least two medical studies on the anti-diabetic drug Avandia (rosiglitazone) suggest that the drug is related to an increased risk of death or disability from heart attack or stroke. In fact, days ago an FDA physician and a leader in the FDA’s cardiovascular division, Dr. Thomas Marciniak, blasted one of GlaxoSmithKline’s trial studies as “inappropriate and biased”.

Dr. Marciniak continued to criticize GlaxoSmithKline’s trial, called RECORD, by stating that it cannot be trusted because of study design and conduct biases that leave estimates of cardiovascular risk of a lower boundary, rather than precise explanation.

In a presentation related to Dr. Marciniak’s findings, he includes a complete analysis of the RECORD study and, frankly, makes an excellent point for suspicion concerning the studies conducted or funded by GlaxoSmithKline:

Avandia is an anti-diabetic drug marketed by GlaxoSmithKline. Avandia is an “insulin sensitizer,” which means that the drug functions by binding to certain receptors in fat cells, thereby enabling the cells to be more responsive to insulin. This in turn helps Type 2 diabetics control their blood sugar.  One of the known problems suffered by diabetics is an increased risk for cardiovascular disease. So, any drug, which “might” increase that already existing risk is potentially dangerous to patients.

The drug was approved for sale in 1999 by the Food and Drug Administration (FDA).  However, earlier this year, the FDA issued a safety warning related to the drug:

Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta- analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.

The two most recent studies on Avandia will are undoubtedly destined to be a focus of a FDA special joint-meeting starting today and extending through tomorrow. This meeting will allow two FDA advisory panels to reevaluate Avandia’s safety in the diabetic drug market and decide whether the drug will remain in the market.

One of the studies, published in the Archives of Internal Medicine, was a meta-data analysis (which combines the results of several studies and evaluates the theories of each study) that found that Avandia had a 28% – 39% increased risk of heart attack when compared to other anti-diabetic drugs. Another study, published by the Journal of the American Medical Association (JAMA), was an observational study that found that the drug, when compared to other anti-diabetic drugs, was associated with an increased risk of stroke and heart failure. These two independent studies, published by credible journals and credible authors provide substantial support for pulling Avandia off the market.

However, other studies published over the past five years, find no such correlation or inherent safety issues with the drug. Thus, the conflicting conclusions found in medical literature will be reviewed by the FDA in July and dictate whether the drug will continue to be available on the market.

If the drug is pulled from the market, it is likely that further research regarding the medical consequences and adverse side effects of the drug will result. The FDA is likely to issue a final report regarding the safety of the drug in mid-July. For now, diabetics using the drug should be cautious and consult their prescribing physician regarding new information about the drug as it becomes available. Remember that no drug therapy should be discontinued or altered by patients without consultation with skilled physicians.

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