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Adverse Events Related to Muraglitazar Use in Diabetes
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To the Editor: The study of muraglitazar and adverse events by Dr Nissen and colleagues1 points out why physicians need hard outcomes data obtained in a blinded fashion before prescribing a new therapy for patients. The study, however, raises broader concerns beyond muraglitazar. Mortality data are needed prior to US Food and Drug Administration (FDA) approval for peroxisome proliferatoractivated receptor (PPAR) agonists, and current practices that use combined therapy for patients with diabetes who have lipid abnormalities need to be examined.
There is a relative paucity of mortality data for fibric acid derivatives compared with data on statins. One of the 3 large studies examining the use of gemfibrozil in the secondary prevention of cardiovascular disease showed a nonstatistically significant 7% increase in total mortality.2 Another study showed a nonsignificant benefit for gemfibrozil, with a 10% reduction in total mortality.3 Bezafibrate was reported to have a nonsignificant 6% higher mortality.4 . . . [Full Text of this Article]
David M. Najman, MD
heartdr@northwestern.edu Evanston Northwestern Healthcare Skokie, Ill
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