A drug commonly used to treat patients with type 2 diabetes mellitus, raises patients' risk of heart attack and cardiovascular death, according to an analysis completed by the Chairman of Cardiovascular Medicine at Cleveland Clinic. In an analysis of 42 trials, Steven Nissen, M.D., found that use of the drug rosiglitazone (Avandia(TM)) raises patients' risk of heart attack and cardiovascular death by 43% and 64%, respectively, in comparison to the use of a placebo or other anti-diabetic therapies. The findings represent a particular public health concern because more than 65% of the deaths amongst diabetic patients are attributed to heart disease. Dr. Nissen's manuscript was posted on-line by the New England Journal of Medicine at 5 pm today and will subsequently appear in the print version of the journal. His co-author is Cleveland Clinic statistician Kathy Wolski. "The results of this analysis raise serious concerns about the cardiovascular safety of rosiglitazone," Dr. Nissen said. "While our study was limited by lack of access to original source data, which would have enabled time-to-event analysis, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes." Rosiglitazone was approved for use by the Food and Drug Administration in 1999, based on the drug's ability to lower blood glucose and reduce glycohemoglobin levels. Since then, approximately 60 million prescriptions have been issued and several million patients currently take the drug. Rosiglitazone is one of the primary therapies used to lower blood sugar in patients with type 2 diabetes. "However, the objective of lowering blood sugar is the reduction of the complications of diabetes," Dr. Nissen explains. "The effect of anti-diabetic therapy on cardiovascular outcomes is of critical importance because cardiovascular disease represents the overwhelming source of diabetic mortality. Unfortunately, rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes, heart disease." In the 42 studies comprising the analysis, 15,560 patients were randomized to regimens including rosiglitazone and 12,283 were assigned to comparator groups that did not. Patients were relatively young, averaging less than 57 years of age for both treatment groups and there was a moderate male predominance (53-61%). 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 2005, there were 2.9 million outpatient visits to Cleveland Clinic. Patients came for treatment from every state and from more than 80 countries. There were nearly 54,000 hospital admissions to Cleveland Clinic in 2005. Cleveland Clinic's Web site address is