The online publication May 21 by the New England Journal of Medicine of a meta-analysis that found use of rosiglitazone by patients with Type 2 diabetes is associated with significantly increased risk for myocardial infarction and with a borderline increase in risk for death from cardiovascular causes resulted in a response statement by medical associations including the American Heart Association.

The Association statement, released on the day of online publication, said “Today the New England Journal of Medicine published an article entitled, "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes." The conclusions of this analysis of previous studies of rosiglitazone (brand name, Avandia) suggest that this oral agent used to treat type 2 diabetes may be associated with increased risk of heart attack and death from cardiovascular causes.”

The statement said that the study deserves serious thought and follow-up, but that physicians should note the overall level of risk associated with rosiglitazone appears to be small. The statement suggests patients talk with their prescribing physicians about their particular risk factors and health history so they can devise the best individual plan while further research is carried out to provide conclusive evidence on the risks and benefits of the drug in this population.

In the meta-analysis, Steven E. Nissen, MD, of the Cleveland Clinic, Cleveland, Ohio, USA, examined data from 42 trials longer than 24 weeks in duration (mean age of patients, 56 years; mean baseline hemoglobin A1c, 8.2%).

The odds ratio for myocardial infarction was 1.43 (P=0.03), whereas the odds ratio for death from cardiovascular causes was 1.64 (P=0.06).