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Avandia Linked with Increased Risk of Death, Heart Attacks

Nov 25, 2008 | Parker Waichman LLP

According to a study published in a recent issue of the Archives of Internal Medicine, the diabetes drug rosiglitazone maleate—also known as Avandia—may increase the risk of certain cardiovascular events.

The study, which was conducted by Dr. Wolfgang Winkelmayer of Brigham and Women's Hospital in Boston and colleagues,  involved patients aged 65 and older who had taken either Avandia or Actos (pioglitazone hydrochloride) for one year. Both Avandia and Actos belong to the same class of diabetes drugs.  Both now contain warning labels about using the medications in patients with existing heart failure.

According to CBCNews.Ca, medical claims data for 28,361 patients were reviewed by the research team—14,260 took Actos; 14,101 took Avandia.  Avandia patients experienced an increased likelihood of death at a rate of 15 percent and a 13 percent increased risk of heart failure, versus those taking Actos.  According to CBCNews.Ca, the Avandia group experienced 1,869 deaths, while only 885 died in the Actos group.  Avandia is made by GlaxoSmithKline and Actos is made by Takeda Pharmaceuticals North America In

 In May 2007, a New England Journal of Medicine study concluded that Avandia increased the risk of cardiovascular problems in those who took it.  U.S. News and World Report noted that the increased risk was at 42 percent and that, based on the study, Avandia might be riskier than Actos.

Both drugs are part of a class of drugs called thiazolidinediones, which are used to lower blood sugar in patients with type 2 diabetes.  According to U.S. News and World Report, the U.S. Food and Drug Administration said that GlaxoSmithKline had agreed to add to the existing "black box" an additional warning about the potential increased risk for heart attacks when taking Avandia.

Winkelmayer says that both Actos and Avandia should be used with caution, with extra caution exercised for heart patients, and that neither drug should be prescribed as initial treatment, according to U.S. News and World Report.  Dr. Eric J. Topol, director of the Scripps Translational Science Institute and chief academic officer at Scripps Health in La Jolla, California, agrees, “The study reinforces the heart failure risk of rosiglitazone versus pioglitazone," Topol told U.S. News and World Report.

Winkelmayer's  study was supported by the American Heart Association and  Satellite Healthcare Inc.  The researchers also received grants from the pharmaceutical companies Amgen, Fresenius Medical Care, and GlaxoSmithKline/

CBCNews.Ca noted that the American Diabetes Association and a European counterpart dropped Avandia from a list of recommended treatments for people with Type 2 diabetes last month.


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