More considered approach to the safety of rosiglitazone needed

May 28 2007

A calmer and more considered approach to the safety of rosiglitazone (Avandia) - the GlaxoSmithKline treatment for type 2 diabetes - is needed to avoid unnecessary panic among patients, says an Editorial published online and in an upcoming edition of The Lancet.

The Editorial discusses the sudden anxiety caused by the publication in the New England Journal of Medicine (NEJM) of a systematic review of trials using rosiglitazone. The NEJM analysis suggests that the risk of a heart attack increases by 43% for patients taking rosiglitazone compared to control groups, and the risk of death by heart attack by 64%.

The tone of the NEJM paper is one of urgency, yet GSK has responded by stating it “strongly disagrees” with its conclusions. Who is right?

Of studies to date, the two most reliable to inform decision making are DREAM (published in The Lancet) and ADOPT (published in the NEJM). DREAM, which involved over 5,000 patients, recorded small increases in cardiovascular events compared to controls, which were not statistically significant. ADOPT involved more than 4,000 patients, with the only significant relevant finding an excess of congestive heart failure episodes for rosiglitazone-treated patients compared with glyburide (22 vs 9 events).

When taken together, the Editorial concludes these results could certainly be a matter of concern; but it says that patients, physicians and the US Food and Drug Administration can reasonably await the results of RECORD – a phase III trial specifically designed to analyse cardiovascular events connected to use of rosiglitazone.

The Editorial says: “Until the results of RECORD are in, it would be premature to overinterpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses.”

It concludes: “To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed.”

http://www.thelancet.com/