Three multicentre, randomized, placebo-controlled trials in non-diabetic and diabetic overweight and obese patients demonstrated that rimonabant effectively reduced body weight and abdominal obesity and improved glucose and lipid metabolism after 1 (RIO-Europe, RIO-Lipids, and RIO-Diabetes) and 2 years (RIO-North America) of treatment. In this paper, Van Gaal et al. report the 2-year efficacy and tolerability data of rimonabant from the RIO-Europe trial. Patients were randomized to double-blind treatment with placebo, rimonabant 5 or 20 mg once daily plus a calorie-restricted diet for 2 years. The major finding was the clinically meaningful weight loss and improvements in serum lipid, glucose, and insulin levels with rimonabant 20 mg. The improvements were maintained over 2 years with favourable safety and tolerability in patients without a history of severe depressive disorder or severe anxiety. Moreover, rimonabant treatment (20 mg) for 2 years improved health-related quality of life (HRQoL) assessed using the obesity-specific Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire. Therefore, this report demonstrated the long-term efficacy and safety of rimonabant 20 mg for improving cardiometabolic risk factors in overweight and obese patients. The paper was accompanied by an editorial by Ulrich Kintscher, which acknowledged the substantial contributions of the 2-year RIO-Europe trial as well as the STRADIVARIUS trial to our understanding of the actions of rimonabant. However, the author underlined that some questions remain regarding the cardiovascular risk reduction and safety of rimonabant and that we will have to see results from ongoing outcome trials such as CRESCENDO to assess the relevance of this pharmacological approach to preventing hard cardiovascular outcomes.
Documentation centre