The Story on Avandia
Earlier this week, the New England Journal of Medicine published a Cleveland Clinic metanalysis of research on the type 2 diabetes drug rosaglitizone (Avandia) and the cardiovascular risk associated with the drug. The findings prompted the U.S. Food and Drug Administration to issue a safety warning on Avandia. GlaxoSmithKline (GSK), the drug's manufacturer, has issued a rebuttal to the study, citing their own "comprehensive and rigorous program of scientific analysis."
If you're currently taking Avandia and have concerns about the recent study, talk to your doctor.
GlaxoSmithKline Strongly Defends Its Record on Avandia
PBS: Online Newshour - Study Raises Concerns About Risk of Diabetes Drugs
New York Times: Heart Attack Risk Seen in Drug for Diabetes
The Cleveland Clinic study used data from many clinical studies done prior to the approval of Avandia, these studies were done to determine safe use of Avandia. Recent large studies ADOPT, DREAM, and The Balanced Cohort Study using Avandia as recommended rebuke Dr. Nissen's claims of heart risk associated with Avandia. Dr. Nissen's use of small patient population, short duration clinical trials used to determine who could safely use Avandia should not be used to determine the safety of Avandia in general use by diabetics in the US. It is also noted that the total deaths he based his remarks on is 39 Avandia verses 22 other and more Avandia patients were in the studies than other patients.
With millions taking Avandia, the high heart rate problems suggested by Dr. Nissen would have stood out long ago. The three studies cited above had over 40,000 patients monitored for more than 70,000 patient years. No way could a trend toward cardio problems be missed!
Chuck