New diabetes pill poses deadly risk
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Posted on Fri, Oct. 21, 2005
New diabetes pill poses deadly risks, study alleges
A new study alleges that Pargluva, a diabetes pill that appeared headed for federal approval, can double the risk of death, heart attacks and strokes.
BY LINDSEY TANNER
CHICAGO - A new diabetes pill that appeared headed for federal approval can double the risk of death, heart attacks and strokes, according to an independent analysis rushed online Thursday because of public safety concerns.
The drug muraglitazar, developed by Bristol-Myers Squibb and Merck & Co. to be sold under the name Pargluva, was endorsed by a Food and Drug Administration panel last month. It is a treatment for Type 2 diabetes, the most common form of the condition that occurs most often in adults who are overweight.
Researchers with the Cleveland Clinic analyzed the data the FDA made public before the panel vote and found that patients taking Pargluva faced double the risk of death, heart attack or stroke, compared with those on dummy pills or a similar drug.
If the analysis is correct, the drug could have meant a ''public health catastrophe,'' said one of the researchers, Dr. Steven Nissen, a prominent heart specialist with Cleveland Clinic.
The analysis was published Thursday morning on the Journal of the American Medical Association's website.
The drug's makers said earlier this week that they had received an ''approvable'' letter from the FDA that also asked for more safety data on the drug's cardiovascular effects.
An FDA spokeswoman said agency officials do not comment on pending drug applications. Calls seeking comment from Merck and Bristol-Myers Squibb were not immediately returned.
The non-insulin drug is designed to lower blood sugar levels and increase levels of ''good'' cholesterol in patients with Type 2 diabetes, the most common form of the disease, which affects about 18 million Americans, many of them black or Hispanic.
The analyzed data involved 3,725 patients who were given Pargluva, a similar drug called pioglitazone, or dummy pills in a variety of studies lasting from 24 weeks to 104 weeks.
Deaths, heart attacks or strokes occurred in 35 of the 2,374 Pargluva patients versus nine of 1,351 patients in a combined group on the other drug or dummy pills, the analysis found.
Slightly higher risks for mini-strokes and heart failure also were found among Pargluva patients.