Cleveland Clinic Study Shows Commonly Used Diabetes Drug Increases Risk of Heart Attack and Cardiovascular Death
May 22, 2007
Digg This! | Send to Newsvine | Add to del.icio.usMay 21, 2007 (PRNewswire) -- 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%).
Posted by dlifenews at May 22, 2007 09:54 AM
Comments
This study depend on very small numbers. The difference in Myocardial Infarctions 86-72 = 14 and deaths was 39-22 = 17. Since some people have serious side effects of water retention or weight gain, the differences could easily be explained by people that should have not been kept on Avandia because of these side effects. The figures might be quite different if they only looked at people that gain less than 5 pounds per year and didn't have water retention problems. It is also odd the the average age was 56 and the average A1C was 8.2.
Other studies contridict these findings.
This study indicates the need for further studies and may indicates that some people with side effects should not be on Avandia. Since there are people that have been on Avandia for more than six years with positive results not atainable with other medications, a lot more works needs to be done before people panic!
Chuck
Posted by: Charles Keyserling at May 23, 2007 12:58 AM