Just as the FDA decides the fate of the controversial Avandia diabetes pill, a new study finds the drug has the same cardiovascular risk as the rival Actos medication. In the latest analysis, about 4 percent of patients taking either pill suffered a heart attack, heart failure, both or died over a 33-month period. The study was publish in Circulation: Cardiovascular Quality and Outcomes (see abstract).

How these results may sway the FDA is unclear. Previous studies - such as this study in the Journal of the American Medical Association - have indicated that cardiovascular risk was greater with GlaxoSmithKline’s Avandia than Takeda’s Actos. You may recall that an FDA advisory panel last month voted to allow Avandia to remain on the market, but recommended restrictions. The agency is in the process of making a final decision.

The study evaluated 28,938 diabetes patients in a database provided by Wellpoint, the big insurer, and found 602 of those on Avandia and 599 taking Actos suffered either a heart attack, heart failure, both, or died. The average patient age was 54, and 58 percent were male. Death records from the National Death Index, a central database administered by the National Center for Health Statistics.
Here’s the breakdown:

•Heart attack – 96 patients on Avandia and 121 patients on Actos;
•Heart failure – 265 patients taking Avandia and 243 taking Actos;
•Heart attack and heart failure – 24 patients on Avandia and 18 on Actos;
•Death – 217 patients taking Avandia and 217 taking Actos.

“Besides its findings that (Avandia and Actos) have comparable risks, what distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths,” says Debra Wertz, the lead author and outcomes research manager at HealthCore, a Wellpoint subsidiary, in a statement. She also claims the study followed patients for a longer period of time than some of the earlier research.