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Pioglitazone Treatment Reduces Risk of Second Heart Attack in Diabetics: Presented at AHA

By Charlene Laino

DALLAS, TX -- November 18, 2005 -- Updated results of one of the largest clinical trials of type 2 diabetics with cardiovascular disease shows that use of the anti-diabetes drug pioglitazone results in a 28% reduction in heart attacks.

Researcher said that patients on pioglitazone also had a 37% relative risk reduction for acute corona syndrome, said Erland Erdmann, MD, Professor of Medicine, University of Koeln, and Director, Third Clinic for Internal Medicine, University of Cologne, Cologne, Germany.

"This study includes one of the largest groups of patients with type 2 diabetes and previous heart attack to be studied in a randomized, placebo-controlled trial," said Dr. Erdmann at a press briefing here on November 17^th at the American Heart Association Scientific Sessions 2005 (AHA).

The main study was released in September at European Association for the Study of Diabetes meeting. The new data presented by Dr. Erdmann is from a subanalysis of the PROspective PioglitAzone clinical Trial In MacroVascular Events (PROactive) study.

The analysis involved 2,445 patients at 321 medical centers in 19 European countries.

The overall study was prompted by observational data that suggested pioglitazone not only helped lower blood glucose, but also had positive effects on blood lipids -- reducing levels of triglycerides and low-density lipoprotein cholesterol while increasing high density lipoprotein cholesterol.

In the study, 47% of patients in the pioglitazone group had serious adverse effects, compared with 51% of patients on placebo. There were increased reports of serious heart failure among pioglitazone patients, but mortality rates in the two groups were similar -- 1.8% for pioglitazone and 1.7% for placebo.

In the primary endpoint of the subanalysis, 5.3% of the 1230 patients on pioglitazone suffered a fatal or non-fatal heart attack in the 3-year study compared to 7.2% of 1215 patients receiving placebo, representing a hazard ratio of 0.72. The difference between the groups reached statistical significance at the P = .045 level.

There was also a 19% risk reduction in the cardiac composite endpoint of non-fatal heart attacks, coronary revascularization procedures, acute coronary syndrome episodes and cardiac death. That risk reduction was also significant at the P = .034 level, Dr. Erdmann said.


[Presentation title: The Effect of Pioglitazone on Recurrent Myocardial Infarction in 2,445 Patients with Type 2 Diabetes and Preexisting Myocardial Infarction - Data from the PROactive Study. Late-Breaker abstract]

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