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What is Pargluva?
Pargluva, which has the generic name of muraglitazar, is sponsored by Bristol-Myers Squibb and Merck, and is a member of a new class of drugs known as dual PPAR-agonists. These are non-insulin drugs designed for type 2 diabetes patients in order to control their blood sugar and improve cholesterol levels by stimulating certain receptors in cells that are responsible for regulating fat and sugar. These drugs are aimed at reducing blood sugar levels while increasing levels of so called "good" cholesterol. Type 2 diabetes affects approximately 18 million people, and is the most widespread form of diabetes.
Pargluva and FDA Approval Problems
Pargluva is only a proposed new type 2 diabetes drug and is not yet FDA approved. An advisory committee for the FDA voted 8-1 recommending approval of the diabetes drug. If approved, Pargluva would be the first of the dual PPAR-agonists class to be approved by the FDA. Recently, Pargluva received a setback in the approval process when an article appeared on the web page of the Journal of the American Medical Association that cited significant heart attack and stroke risks from the new drug. Reports show that those taking Pargluva had approximately twice the risk of heart attack, stroke, or death compared to placebo patients. In Pargluva trials, 2.11 percent of patients who were treated with Pargluva suffered cardiovascular problems ranging from heart attack and stroke to congestive heart failure. In contrast, the control group had cardiovascular problems at the rate of only 0.81 percent.
An editorial by Dr. James M. Brophy of McGill University in Montreal that was printed with the article indicated that there might also be a cancer risk associated with Pargluva. The editorial by Brophy also mentions that the data reported to the FDA "may have fostered an illusion of safety," and Dr. Brophy detailed multiple instances where the manner in which patient trials were conducted may have been slanted in favor of approval of Pargluva. Pargluva is still approvable, but the FDA has requested additional information concerning cardiovascular effects and the FDA has said that Pargluva would be approvable only after additional completed studies of the drug are reviewed.
Link To Lawyer Seek's Pargluva Content:
<a href='http://www.lawyerseek.com/Practice/Pharmaceutical-Injury-C1/Pargluva-P23/'>Pargluva: Lawyer Seek</a> |
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