Muraglitazar May Be Riskier Than Thought
Diabetes drug OK'd by FDA Panel, but re-analysis suggests it may have greater mortality risk
FRIDAY, Oct. 21 (HealthDay News) -- The type 2 diabetes drug muraglitazar (Pargluva) is awaiting approval by the U.S. Food and Drug Administration, but an early-release study in the Journal of the American Medical Association suggests the drug has more than double the risk of a combined endpoint of death, myocardial infarction and stroke than other drugs.
Steven E. Nissen, M.D., of the Cleveland Clinical Foundation, and colleagues re-analyzed data submitted to the FDA that was used in September by an advisory panel to recommend the drug be approved. The data from five clinical trials included 2,374 patients who took muraglitazar and 1,351 patients who took either pioglitazone or a placebo.
The researchers found a 2.23 relative risk of a composite endpoint of death, myocardial infarction and stroke in muraglitazar-treated patients compared with patients treated with the other drug or placebo (1.47% versus 0.67%).
"Although muraglitazar may yet prove to be a valuable addition to the clinical armamentarium, the meticulous examination of the current evidence by Nissen and colleagues should focus serious attention on the potential cardiovascular risks of this drug," according to an editorial by James M. Brophy, M.D., Ph.D., of McGill University Health Center, in Montreal.
Bristol-Myers Squibb and Merck are collaborating on production of the drug.