Wednesday May 23, 2007
Avandia's controversy

This week The New England Journal of Medicine has early published an online (for paper print due on June 14, 2007), meta-analysis of 42 trials with more than 24 weeks of exposure with drug Rosiglitazone (avandia). 15,560 patients were randomly assigned to treatment regimens that included rosiglitazone, and 12,283 were assigned to comparator groups with regimens that did not include Avandia 1, 2.

Results showed that in the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 (P=0.03), and the odds ratio for death from cardiovascular causes was 1.64 (P=0.06).

But makers of Avandia GlaxoSmithKline promptly rejected the results of meta-analysis with strong references from other studies (like ADOPT 4 , DREAM 5 and RECORD 6 studies) showing no increase in cardivascular events 3.

As controversy has created so much media attention that FDA issued a statement which can be read here



Previous related pearl: Avandia associated exacerbation of CHF



References: click to get abstract/article

1. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes - Article published at www.nejm.org May 21, 2007, due to print on june 14, 2007
2. Rosiglitazone and Cardiovascular Risk - editorial, published at www.nejm.org May 21, 2007, due to print on june 14, 2007
3. response from GlaxoSmithKline at avandia.com
4. A Diabetes Outcome Progression Trial (ADOPT), Diabetes Care 25:1737-1743, 2002
5. DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators; - Lancet. 2006 Sep 23;368(9541):1096-105
6. Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol. Diabetologia. 2005 Sep;48(9):1726-35.