Pargluva Drug for Diabetes found to be Dangerous

October 22nd 2005

A new treatment for type-2 diabetes may double the risk of death according to researchers at the Cleveland Clinic.  If the analysis is correct Pargluva (muraglitazar is the generic name), a drug developed by Bristol-Myers Squibb and Merck & Company, could cause a “public health catastrophe”. 

The research was published by the Journal of the American Medical Association.  Muraglitazar is a new drug used to treat both high glucose levels and improve blood lipids.  The drug was approved on October 18^th by the Food and Drug Administration (FDA). 

The Journal reports that “in a review of data from Phase 2 and 3 trials conducted by the drug manufacturer and provided to the FDA, Nissen and colleagues found that muraglitazar was associated with an excess incidence of the composite endpoint of death, major adverse cardiovascular events, and congestive heart failure.”

These new findings could prevent a disaster since 18 million Americans suffer from diabetes.  Dr. Steven Nissen told reporters that “this is a Vioxx that isn’t going to happen”.  The FDA has not made a comment about the new findings yet.

Bristol-Myers Squibb and Merck said in a statement that Pargluva "was extensively studied, and all available data were reported to the FDA."  It was hoped that Pargluva would be the first diabetes drug designed to lower blood sugar, reduce fatty triglycerides and increase levels of "good" cholesterol, according to Nissen.

According to an editorial author Dr. James Brophy at the McGill University “Company-provided data might have fostered an "illusion of safety" because of numerous omissions, such as excluding patients most likely to face cardiovascular risks, including elderly diabetics” the Indianapolis Star reported

Dr. Nissen also said "I expected the advisory panel to turn the drug down."  Of the 18 million diabetics roughly 80% will die from the disease.  If the drug is used it should be scrutinized and high risk patients should not take it.

By Dan Wilson
Best Syndication Staff Writer

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