| Diabetes Drug Pargluva, A Booster for Cardiac Diseases |
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Chicago(24x7 Updates) -- The Journal of American Medical Association rushed online on Thursday an analysis which shows the new diabetes pill "Pargluva" significantly increases the risk of heart attack and strokes.
The drug which belongs to the class of drugs called dual peroxisome proliferator-activated receptors (PPARs), which affect both cholesterol levels and blood sugar levels in diabetic patients, more than doubles the risk of life-threatening cardiovascular complications, the researchers concluded after analyzing the same studies the drug’s maker presented to the FDA. They said the agency should not approve the drug until additional research is conducted.
Dr. Steven Nissen, one of the researchers who was instrumental in publicizing a similar risk posed by painkiller, Vioxx said same data that led a U.S. Food and Drug Administration advisory panel last month to suggest Pargluva be approved was analyzed for these findings.
The 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.
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.
Dr. Nissen said, however, that the analysis is limited because he and his colleagues only had access to data included in the FDA filing rather than data from the original clinical trial databases.
In an editorial that accompanied the study, James M. Brophy, M.D., Ph.D., wrote that the analysis by Dr. Nissen and colleagues was meticulous and it "should focus serious attention on the cardiovascular risks of this drug." He added that also unanswered are "residual safety concerns surrounding carcinogenicity also have not been completely resolved."
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