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Study Finds Pargluva May Increase Risk of Heart Attack or Stroke

Source: The Journal of the American Medical Association

Pargluva, a proposed diabetes drug from Bristol-Myers Squibb and Merck & Company, appears to increase the risk of death, heart attack or stroke, according to a study published in a leading medical journal last week.

The study was conducted by the two Cleveland Clinic cardiologists who warned in 2001 about the cardiovascular risks associated with Vioxx, which was pulled from the market last year. They used the data, from the company-funded clinical trials, that was submitted to the Food and Drug Administration.

Their analysis found 1.47 percent of the diabetic patients who took Pargluva during clinical trials died, suffered a heart attack or stroke-more than double the rate among those taking a placebo or an already approved rival drug sold as Actos.

James Brophy of McGill University in Montreal wrote an accompanying editorial for the study that was also published in The Journal of the American Medical Association, where he questions the "methodological decisions in the sponsor's FDA application" that may foster an illusion of safety for Pargluva. He also included a list of 8 methods observed in the application that in his opinion may have contributed to an overestimate of the safety profile.

Read Full Story at The Journal of the American Medical Association

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