Could Avandia be the next Vioxx? The NEJM with some smoke. Will fire be far behind?
Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance. Our study was limited by a lack of access to original source data, which would have enabled time-to-event analysis. Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes.
The author of the study, Dr. Steven Nissen backs away from suggesting what to do:
Is there a case for prescribing Avandia? Are there some patients for whom the benefits outweigh the risks? Again, I don’t think I want to go there. It’s important for me as a physician-scientist to put the data out there in a very neutral fashion, and not cast judgment about what people ought to do. We’re going to let everybody read our paper and make up their own minds.
I’ll be expecting a lot of patient calls tomorrow.
Update 2 -
MedPage Today with the best perspective thus far, comparing the findings to PremPro and Vioxx:
A meta-analysis of data from 42 clinical trials found a 43% increase in relative risk of myocardial infarction among type 2 diabetics treated with rosiglitazone (Avandia).
The odds ratio for MI was 1.43 (95% confidence interval 1.03-1.98, P=0.03), said Steven E. Nissen, M.D., of the Cleveland Clinic, lead author of the meta-analysis, which was released online today by the New England Journal of Medicine . . .
. . . To put those data in perspective, the Women’s Health Initiative (WHI), which used patient-level data, found that use of Prempro was associated with a 29% increase in relative risk in the combined endpoint of non-fatal MI and death from coronary heart disease. A 2001 study co-authored by Dr. Nissen (JAMA 2001; 286:954-959) reported that rofecoxib (Vioxx) was associated with a 2.38 OR for thromboembolic events (95% CI, 1.49-4.00 P=0.002).
Update 3 -
This smaller study touting the ulcerative colitis benefits of Avandia picked a bad day to be released.
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