Diabetes drug Pioglitazone reduces risk of death, heart attack and stroke, but increases risk of heart failure

A drug widely used to treat type 2 diabetes has been found to reduce the risk of death, heart attack (myocardial infarction) or stroke when used alone or in combination with other therapies for diabetes, according to a Cleveland Clinic study.

The study published in the Sept. 12 issue of the Journal of the American Medical Association reports that use of pioglitazone (Actos) is associated with a significantly lower risk of death, myocardial infarction, or stroke among a diverse population of diabetic patients.

In a meta-analysis of 19 trials comprising 16,390 patients, researchers found that 4.4% (375) of the 8,554 patients prescribed pioglitazone either died or suffered a heart attack or stroke compared 5.7% (450) of 7,836 patients in a control group who received a placebo or other anti-diabetic therapy.

The study also showed that patients receiving pioglitazone were more likely to experience fluid retention leading to serious heart failure, although this risk did not diminish the favorable effect of the drug on cardiac death or heart attack. Investigation of the cardiovascular effects of anti-diabetic therapies is critical because more than 65% of the deaths among diabetic patients are attributed to heart disease.

"The findings in this study suggest that pioglitazone provides cardiovascular benefits to diabetic patients beyond its effect on lowering blood sugar, with important reductions in the risk of death, heart attack or stroke among patients who receive this drug," said A. Michael Lincoff, M.D., Vice Chairman for Research in the Department of Cardiovascular Medicine at Cleveland Clinic. "Similarly, the results indicate that the potential for serious heart failure does not diminish the drug's overall effectiveness and benefit to patients."

To carry out the research, the drug's manufacturer, Takeda of Lincolnshire, Ill., transferred a database containing individual patient data collected during clinical trials of pioglitazone to Cleveland Clinic's Cardiovascular Coordinating Center for independent analysis. Although funding was provided, the company played no role in conducting the analysis. All the studies were randomized, double-blinded, and controlled with placebo or active comparator. The period of time in which patients received treatment ranged from four months to 3.5 years.

In addition to Dr. Lincoff, researchers involved in the study included Stephen J. Nicholls, M.B.B.S., Ph.D., a Cleveland Clinic cardiologist; Steven Nissen, M.D., Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic; and Cleveland Clinic statistician, Kathy Wolski.

The study of pioglitazone follows a meta-analysis Dr. Nissen and Ms. Wolski conducted earlier this year on the use of rosiglitazone (Avandia(TM)), another commonly used diabetes drug. In his analysis of 42 clinical trials, Dr. Nissen found that rosiglitazone raised patients' risk of heart attack and cardiovascular death by 43% and 64%, respectively in comparison to the use of a placebo or other anti-diabetes therapy.

Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Approximately 1,800 full-time salaried physicians and researchers at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2006, there were 3.1 million outpatient visits to Cleveland Clinic. Patients came for treatment from every state and from more than 80 countries. There were more than 53,000 hospital admissions to Cleveland Clinic in 2006. Cleveland Clinic's Web site address is www.clevelandclinic.org.

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