Rosiglitazone, CVD link worrisome but inconclusive, cardiologists say
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Data on the relationship between thiazolidinediones and cardiovascular risks, particularly ischemic heart disease, are inconclusive, concluded a new science advisory from the American Heart Association and the American College of Cardiology Foundation.
The advisory, which was published online Feb. 23 by Circulation, summarized existing research on the type 2 diabetes drugs, especially focusing on the medications' impact on macrovascular complications. Conventional risk-reduction measures, such as lifestyle modification, are the best proven methods of reducing macrovascular disease, and there is inconclusive evidence that rosiglitazone (but not pioglitazone) may harm rather than help.
However, there are insufficient data to recommend the use of pioglitazone over rosiglitazone, the advisory concluded. The experts recommended that thiazolidinediones not be used with an expectation of preventing ischemic heart disease events. The drugs increase the risk of heart failure and should not be used in patients with class III or IV congestive heart failure, they noted.
The advisory called for immediate additional research into the cardiovascular effects of these drugs and asked the FDA to require such trials as a part of approval of new glucose-lowering agents. The FDA also issued a statement on rosiglitazone and cardiovascular safety last week, noting that data from the RECORD trial are still being reviewed. No new conclusions or recommendations are being issued at this time and the agency's full review will be presented in July 2010, according to an FDA communication.