Type 2 diabetes is a serious and sometimes life-threatening disease. It is a leading cause of coronary heart disease , blindness, kidney failure , and limb amputation . Based on evidence that it can reduce blood glucose levels, the medication rosiglitazone (Avandia) was approved by the US Food and Drug Administration (FDA) in 1999 for the treatment of type 2 diabetes.
Now, a new study in the June 14, 2007 issue of the New England Journal of Medicine has put the safety of rosiglitazone into question. After looking at dozens of studies investigating the effects of rosiglitazone, researchers found that the medication was associated with a 43% increase in the risk of heart attack .
About the Study
Researchers from the Cleveland Clinic identified 42 studies that assigned a total of 15,560 participants to take rosiglitazone and 12,283 participants to take a comparator (ie, placebo or another antidiabetic medication). Five of the studies had been submitted to the FDA in 1999 for drug approval, 35 were studies in the GlaxoSmithKline (the manufacturer of rosiglitazone) clinical-trial registry, and the other two were large, recently published trials.
Overall, there were 86 heart attacks and 39 cardiovascular-related deaths in the rosiglitazone group, and 72 heart attacks and 22 cardiovascular deaths in the control group. Compared to the control group, the risk of heart attack was significantly increased by 43% in the rosiglitazone group. The risk of cardiovascular death was increased by 64% in the rosiglitazone group, but that finding was of borderline significance.
These findings are limited because there were a relatively small number of heart attacks and cardiovascular deaths, which could compromise the results’ accuracy.
How Does This Affect You?
This study suggests that there are potential safety issues related to rosiglitazone. Taking this medication may increase the risk of heart attack and possibly heart-related deaths. This is particularly important, since people with diabetes are already at increased risk for cardiovascular causes.
But if you are taking rosiglitazone, do not stop on your own. In some cases, the benefits of taking rosiglitazone may still outweigh its risks. Fortunately, there are a variety of effective diabetes medications that have not run into the same safety issues as rosiglitazone and other medication in its thiazolidinedione (glitazone) class. At this point, the best thing to do is to talk with your doctor about your personal risks and benefits associated with taking rosiglitazone.
- Reviewer: Richard Glickman-Simon, MD
- Review Date: 06/2007 -