Rimonabant and the FDA

Rimonabant, the long-awaited weight-loss and smoking-cessation drug that is available in most Western countries except the U.S., took another blow this week at the American College of Cardiology Scientific Sessions in Chicago, where the results of the STRADIVARIUS trial were presented.

In this trial, obese patients randomized to receive rimonabant lost significantly more weight and more inches from their waists than patients on placebo, and in addition they had significantly improved HDL, triglyceride, and CRP levels. But unfortunately, the volume of their atherosclerotic plaques (the primary endpoint of the study) was not significantly improved over the placebo group. Furthermore, patients on rimonabant had a significantly higher incidence of psychiatric effects, mainly depression and suicidal ideation.

This study may prove to be the final nail in the coffin for rimonabant in the U.S. American doctors and patients who have been anxious for the approval of rimonabant, and who may wonder why the FDA would refrain from approving a drug that significantly improves weight loss, smoking cessation, and lipid and inflammation profiles, should read this article on rimonabant and the FDA.