Sunday, December 16, 2007

Avast the Avandia

I give up, no more Avandia. The future is not rosy for rosiglitazone. This diabetic medication has been under fire for some time now as studies link it to increased risk of heart attack, congestive heart failure, and death.

The latest damning evidence comes from a study just published in the Journal of the American Medical Association. Previous negative statistics came from clinical trials, looking at studies studying the efficacy of this drug in controlling diabetes. On average, such research on diabetic drugs is conducted on patients younger than 65. This latest research looked at a 'real-world population,' the over-65 set that has the highest prevalence of diabetes of any age group.

Nearly 160,000 such oldsters were followed for nearly 4 years. As expected in this kind of group, a fair number--around 8%--were hospitalized for congestive heart failure (CHF), and a similar number experienced heart attacks (MI). 19% pitched over dead. Matching the unfortunates on Avandia compared with those on other classes of diabetic drugs, the Avandiful were at 1.6 times greater risk for CHF, 1.4 times higher for MI, and 1.29 times moreso for death.

Given that diabetics, particularly older diabetics, are a high risk group for heart-related troubles, these numbers are strong arguments against the use of Avandia. GlaxoSmithKline, the maker of Avandia, had this to say:

These conclusions are inconsistent with a more robust body of evidence from large, long-term, prospective, well-designed clinical studies, including A Diabetes Outcome Progression Trial (ADOPT) and the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD). These long-term trials in diabetic patients comparing rosiglitazone with other oral antidiabetic medicines show no increased risk for cardiovascular events compared with other commonly used medications, other than the well-known risk of congestive heart failure with thiazolidinediones.

Dr. Steve Nissen of the Cleveland Clinic, a long-time critic of Avandia, countered that it is: impossible to ignore the evidence of increased risk of MI with rosiglitazone, which has been shown in four meta-analyses and now in this independent observational study. The conclusion that rosiglitazone increases the risk of MI is simply inescapable. The contrary 'evidence' cited by GlaxoSmithKline is not credible.

I'm going with Steve on this one. We have good alternatives for diabetic treatment.


Fat Doctor said...

I liked Avandia, never had any adverse effects in the couple of years I used it. Now I'm stuck with patients who are elderly, don't do well with sulfonylureas and can't/won't tolerate GI side effects of metformin even with ramping them up SLOWLY. Still, I'm not starting anybody on Avandia now... Argh.

Femail doc said...

FD: I've had great luck with Januvia. Too bad it's so expensive. Actos apparently not implicated in high risk cardiovascular events, but always some worry that this is a class-wide problem.