A. Michael Lincoff, M.D., and colleagues at the Cleveland Clinic, conducted a meta-analysis of research to evaluate the effect of pioglitazone on the incidence of ischemic cardiovascular complications for patients with type 2 diabetes. Previous evidence had been insufficient to evaluate this effect. This analysis included 19 randomized trials and 16,390 patients. Duration of pioglitazone use ranged from 4 months to 3.5 years.

The researchers found that heart attack, stroke or death occurred in 375 (4.4 percent) of 8,554 patients receiving pioglitazone and 450 (5.7 percent) of 7,836 patients treated with control therapy, an 18 percent relative reduction. These outcomes were all reduced by a similar magnitude with pioglitazone treatment. Serious heart failure was reported in 200 (2.3 percent) of pioglitazone-treated patients and 139 (1.8 percent) of control patients.

These findings suggest that the net clinical cardiovascular benefit with pioglitazone therapy is favorable, with an important reduction in irreversible ischemic events that is not attenuated by the risk of more frequent heart failure complications, the authors write.

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Based on the analysis, the researchers estimate that for every 220 diabetic patients treated with Avandia for one year, one will have a heart attack linked to the drug. And, there would be one case of heart failure for every 30 people taking the drug for one year.

There is no need for physicians, health plans or patients to wait for regulatory action, said Curt Furberg, M.D., Ph.D., a co-author of the report. On the contrary, they should take prompt action and restrict the use of Avandia, especially since safer alternatives are available.

Avandia received regulatory approval in 1999 and at that time no serious adverse events were recognized. However, since approval, Avandia has been linked to heart failure, vision loss, heart attacks and fractures in women.

The current analysis looked at potential links between the drug and heart attacks, death from cardiovascular causes, and heart failure, which is the inability of the heart to meet the body's demands.

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