Actos Still Has Many Benefits for Type 2 Diabetics, Cleveland Clinic Study Shows

Recently the FDA warned consumers that several diabetes medications, including Actos (pioglitazone), could cause heart failure. However, the Cleveland Clinic has just issued a press release that shows that, despite this increased risk of heart failure, pioglitazone reduces the risk of death, heart attack and stroke in type 2 diabetics. This new information, obviously, makes the use of pioglitazone a double-edged sword that physicians need to think about and weigh the risks with the benefits.

The Cleveland Clinic study was published in the September 12 issue of the Journal of the American Medical Association. In a meta-analysis of 19 trials comprising of 16, 390 patients, 4.4% (375) of the 8,554 patients who were taking pioglitazone died or suffered from a stroke or a heart attack. Compare these numbers with the 5.7% (450) of 7,836 patients in a control group who took a placebo or other anti-diabetic medication who suffered the same fate.

However, the bad news is that patients who took pioglitazone were more prone to have fluid retention that could end in serious heart failure. It is very important that more studies be done to find out what factors contributed to these cardiovascular problems because more than 65% of the fatalities among diabetic patients are a result of 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 in the press release. "Similarly, the results indicate that the potential for serious heart failure does not diminish the drug's overall effectiveness and benefit to patients."

The drug's manufacturer, Takeda, located in Lincolnshire, Illinois, gave the Cleveland Clinic access to their database, which contained patient data collected during the clinical trials of pioglitazone. These studies were all double-blinded and controlled with a placebo or active comparator. The patients involved in these particular studies took the medication anywhere from four months to 3.5 years. The researchers included in this study were Dr. Lincoff, 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.

Dr. Nissen and Ms. Wolski conducted a study earlier this year on rosiglitazone (Avandia). During the 42 clinical trials, Dr. Nissen discovered that rosiglitazone raised the patients' heart attack risk and cardiovascular death by 43% and 64%, respectively when compared to the placebo. Therefore, it is clear that pioglitazone is a safer choice for type 2 diabetics. Despite these new findings, it is important for individuals to seriously discuss the use of this medication with their physicians. Only they are able to know if the benefits of pioglitazone are worth the potential risks.

SOURCE:

The Cleveland Clinic News Release. URL: (http://www.clevelandclinic.org/media/release.asp?Press_Releases_No=876)