Avandia Questions

The authors of the article examined data from a pooled analysis (meta-analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes, and concluded that "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."

Apparently the NEJM article was released a few hours earlier than had been originally planned, and the stock market picked it up, and the share price of the manufacturer (GlaxoSmithKline) fell – leading to a media frenzy breathlessly exaggerating the results of the study on the evening news. The FDA promptly issued a Safety Alert with their take on the safety of Avandia. (I’ve reproduced it at the end of this SharePost.) And, of course, GSK issued a rebuttal press release. But as the media buzz increased, inevitably patients taking Avandia became more worried.

Today, I’ve seen several questions from patients concerned about this issue, and I thought I’d use this forum to answer those questions.

Q) I'm currently using Actos [the other TZD], should I discuss with my doctor about stopping it?

A) Avandia and Actos are both in the same class of medications, and thus there is a possibility that any side effect seen with one might occur with the other. That said, the NEJM article was specifically about Avandia, and the authors stated that Actos was different: "The question as to whether the observed risks of rosiglitazone represent a "class effect" of thiazolidinediones must also be considered. Pioglitazone is a related agent also widely used to treat type 2 diabetes mellitus. However, unlike rosiglitazone, pioglitazone has been studied in a prospective, randomized trial of cardiovascular outcomes, called Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROACTIVE). The primary end point, a broad composite that included coronary and peripheral vascular events, showed a trend toward benefit from pioglitazone (hazard ratio, 0.90; P=0.095). A secondary end point consisting of myocardial infarction, stroke, and death from any cause showed a significant effect favoring pioglitazone (hazard ratio, 0.84; P=0.027). Notably, pioglitazone appears to have more favorable effects on lipids, particularly triglycerides, than does rosiglitazone."