Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: the STRADIVARIUS randomized controlled trial.

Description

The selective cannabinoid type 1 antagonist rimonabant is thought to be a potentially relevant strategy for the management of high-risk abdominal obesity. However, whether rimonabant can slow the progression of coronary disease is yet not known. The objective of the STRADIVARIUS randomized double-blind placebo-controlled trial was to document the effect of 20 mg/day of rimonabant on the change in percent atheroma volume (PAV) as assessed by intravascular ultrasonography (IVUS). A total of 839 patients with coronary artery disease and abdominal obesity were randomized to either placebo or rimonabant for a period of 18 months. Despite significant and greater decreases in body weight, waist circumference, triglyceride and insulin levels, increases in HDL cholesterol levels, and less increase in HbA1c with rimonabant than placebo, the study failed to show a significant effect on the primary outcome PAV. However, rimonabant improved other IVUS outcomes such as total atheroma volume and mean maximum atheroma thickness. This paper was accompanied by an editorial by Rumsfeld and Nallamothu who discussed the risks and benefits of rimonabant and other issues relating to the STRADIVARIUS trial. They mentioned the limitations of IVUS, highlighting the fact that changes in IVUS-derived parameters have not yet been linked to lower rates of mortality or myocardial infarction. Rumsfeld and Nallamothu also extensively discussed the potential side effects of rimonabant, which may include anxiety and depression, and emphasized that the relationship between obesity, weight loss, rimonabant, and psychiatric side effects should be studied further.