Results from an updated meta-analysis published in the Archives of Internal Medicine indicate that rosiglitazone therapy is associated with an increased risk for myocardial infarction (MI), but not cardiovascular (CV) mortality.

The results add weight to recent suggestions by some researchers that rosiglitazone should be withdrawn from the market or placed under severe restrictions, as reported by MedWire News.

Steven Nissen and Kathy Wolski from the Cleveland Clinic in Ohio, USA, included all randomized controlled trials of rosiglitazone with a duration of at least 24 weeks and similar treatment periods for rosiglitazone and the control drug.

In total, 56 trials were included with a combined cohort of 35,531 patients: 19,509 who received rosiglitazone and 16,022 who received control therapy (any drug other than rosiglitazone including placebo).

They found that rosiglitazone therapy was associated with a 28% increased relative risk for MI versus control therapy.

However, CV mortality was not significantly increased in rosiglitazone treated patients compared with those treated with control therapy.

“The results of the current meta-analysis suggest an unfavorable benefit to risk ratio for rosiglitazone use,” write the authors.

They add that the implication of these results warrant further discussion as “even a modest increase in the risk of MI in a diabetic population would have serious consequences.”

A US Food and Drug Administration (FDA) advisory committee recently voted to keep rosiglitazone on the market, at least until results from the ongoing Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) trial are released. A similar review is currently being carried out by the European Medicines Agency.

The FDA committee also voted for the addition of increased safety warnings to the rosiglitazone drug label, but exact changes have yet to be finalized.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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