European Heart Journal Advance Access originally published online on April 15, 2008
European Heart Journal 2008 29(14):1761-1771; doi:10.1093/eurheartj/ehn076
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Long-term effect of CB1 blockade with rimonabant on cardiometabolic risk factors: two year results from the RIO-Europe Study
1 Department of Diabetology, Metabolism, and Clinical Nutrition, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem-Antwerp, Belgium
2 Division of Diabetes, Nutrition, and Metabolic Disorders, Academic Hospital, University of Liège, Liège, Belgium
3 Obesity Research Unit, Helsinki University Central Hospital, Helsinki, Finland
4 Obesity Unit, Karolinska University Hospital, Huddinge, Sweden
5 sanofi-aventis, Paris, France
6 Service de Diabétologie, Maladies Métaboliques, Maladies de la Nutrition Hôpital, Jeanne d’Arc, CHU de Nancy, Toul, France
Received 16 July 2007; revised 28 December 2007; accepted 1 February 2008; online publish-ahead-of-print 15 April 2008.
* Corresponding author. Tel: +32 3 821 32 66/75, Fax: +32 3 825 49 80. Email: luc.van.gaal{at}uza.be
See page 1709 for the editorial comment on this article (doi:10.1093/eurheartj/ehn255)
Aims: Rimonabant, the first selective cannabinoid type 1 receptor blocker, has been shown to produce weight loss and improvements in several cardiometabolic risk factors over 1 year. We report the 2 year efficacy and tolerability data of rimonabant.
Methods and results: Patients with a body mass index 
30 or >27 kg/m2 with treated/untreated hypertension, dyslipidaemia, or both, were randomized to double-blind treatment with placebo, rimonabant 5 or 20 mg once daily plus a calorie-restricted diet for 2 years. Weight loss from baseline to 2 years in the intention-to-treat population was significantly greater with rimonabant 20 mg (mean ± SD: –5.5 ± 7.7 kg; P < 0.001) and 5 mg (–2.9 ± 6.5 kg; P = 0.002) than placebo (–1.2 ± 6.8 kg). Rimonabant 20 mg produced significantly greater improvements than placebo in waist circumference, high-density lipoprotein cholesterol, triglycerides, fasting glucose and insulin levels, insulin resistance, and metabolic syndrome prevalence. Rimonabant 20 mg produced clinically meaningful improvements in all Impact of Weight on Quality of Life-Lite questionnaire domain scores at 2 years. Rimonabant was generally well tolerated and rates of adverse events, including depressed mood disorders and disturbances were similar to placebo during year 2. Proportions of patients with clinically significant depression (Hospital Anxiety and Depression Scale score >11) were similar in all treatment groups.
Conclusion: Rimonabant 20 mg over 2 years promoted clinically relevant and durable weight loss and improvements in cardiometabolic risk factors.
Key Words: CB1 receptor • Cardiovascular risk factors • Endocannabinoid system • Overweight • Obesity • Rimonabant
Clinical Trial Registration No. NCT00386061
[ClinicalTrials.gov]
http://www.clinicaltrials.gov/ct/show/NCT00386061?order=1.
Members are listed in the appendix.
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Related articles in EHJ:
- The cardiometabolic drug rimonabant: after 2 years of RIO-Europe and STRADIVARIUS
- Ulrich Kintscher
EHJ 2008 10.1093/eurheartj/ehn255.[Extract] [Full Text]
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  U. Kintscher The cardiometabolic drug rimonabant: after 2 years of RIO-Europe and STRADIVARIUS Eur. Heart J., July 2, 2008; 29(14): 1709 - 1710. [Full Text] [PDF]
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