Journal Article

Effect of rimonabant on carotid intima–media thickness (CIMT) progression in patients with abdominal obesity and metabolic syndrome: the AUDITOR Trial

Job, Bernard, O'Leary, Daniel H, Després, Jean-Pierre, Zhou, Rong, Zabbatino, Salvatore M, Brown, Michael W, Nissen, Steven E, Visseren, Frank L J, Reuwer, Anne Q, Deanfield, John E, Kastelein, John J P

2011

Overview

ObjectiveThe aim of this trial was to determine whether obese patients benefit from treatment with rimonabant in terms of progression of carotid atherosclerosis. Rimonabant, a selective cannabinoid-1 receptor blocker, reduces body weight and improves cardiometabolic risk factors in patients who are obese.Design, setting, patients, interventions and resultsA prospective, double-blind, placebo-controlled trial (Atherosclerosis Underlying Development assessed by Intima–media Thickness in patients On Rimonabant (AUDITOR)) randomised 661 patients with abdominal obesity and metabolic syndrome to rimonabant or placebo for 30 months of treatment. The absolute change in the average value for six segments of far wall carotid intima–media thickness from baseline to month 30 was 0.010±0.095 mm in the rimonabant group and 0.012±0.091 mm in the placebo group (p=0.67). The annualised change was an increase of 0.005±0.042 mm for the rimonabant-treated group and 0.007±0.043 mm for the placebo-treated group (p=0.45).ConclusionsThere was no difference in atherosclerosis progression between patients receiving rimonabant for 30 months and those receiving placebo for the primary efficacy measure (absolute change in carotid intima–media thickness). These findings are consistent with a similar study using coronary intravascular ultrasound and another study evaluating the occurrence of cardiovascular events. Our findings suggest that a 5% loss of body weight over a 30-month period with rimonabant is insufficient to modify atherosclerosis progression in the carotid artery in obese patients with metabolic syndrome.Clinical trial registration informationclinicaltrials.gov Identifier: NCT00228176.

• Publisher: BMJ Publishing Group Ltd and British Cardiovascular Society,BMJ Publishing Group,BMJ Publishing Group LTD
• Subject: Anti-Obesity Agents - adverse effects / Anti-Obesity Agents - therapeutic use / Atherosclerosis / Biological and medical sciences / Canada / Cardiology. Vascular system / Carotid Arteries - diagnostic imaging / Carotid Arteries - drug effects / Carotid Arteries - metabolism / Carotid Artery Diseases - diagnostic imaging / Carotid Artery Diseases - drug therapy / Carotid Artery Diseases - metabolism / Chi-Square Distribution / Disease Progression / Double-Blind Method / drugs / Europe / Female / Humans / imaging-obesity / Insulin resistance / Kaplan-Meier Estimate / Low density lipoprotein / Male / Medical sciences / Metabolic diseases / Metabolic syndrome / Metabolic Syndrome - drug therapy / Metabolic Syndrome - metabolism / Miscellaneous / Obesity / Obesity, Abdominal - drug therapy / Obesity, Abdominal - metabolism / Obesity, Abdominal - physiopathology / Other metabolic disorders / Piperidines - adverse effects / Piperidines - therapeutic use / Placebo Effect / Prospective Studies / Pyrazoles - adverse effects / Pyrazoles - therapeutic use / Receptor, Cannabinoid, CB1 - antagonists & inhibitors / Receptor, Cannabinoid, CB1 - metabolism / statistics / Time Factors / Treatment Outcome / Tunica Intima - diagnostic imaging / Tunica Intima - drug effects / Tunica Intima - metabolism / Tunica Media - diagnostic imaging / Tunica Media - drug effects / Tunica Media - metabolism / Ultrasonography / United States / Waist Circumference - drug effects / Weight Loss - drug effects