TY - JOUR
T1 - Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes
T2 - a randomised controlled study
AU - Scheen, André J.
AU - Finer, Nick
AU - Hollander, Priscilla
AU - Jensen, Michael D.
AU - Van Gaal, Luc F.
N1 - Funding Information:
RIO-Diabetes was sponsored by Sanofi Synthelabo Research, a division of Sanofi Synthelabo Inc, a member of the sanofi-aventis group. Editorial support for this article was provided by Sanofi Synthelabo Research.
Funding Information:
A J Scheen is a consultant for sanofi-aventis, AstraZeneca, GlaxoSmithKline, and Merck-Santé, and has received lecture fees from sanofi-aventis. N Finer is a consultant for Novartis, Shionogi, Merck, Abbott, sanofi-aventis, Ajinomoto, and GlaxoSmithKline, and has received lecture fees from Abbott, sanofi-aventis, Roche, and Novo-Nordisk. He has also received grant support from Merck, Novartis, Roche, the EU Framework 6 ‘Diabesity’ grant, Alizyme, Abbott Laboratories, and sanofi-aventis. P Hollander is a consultant for, and has received lecture fees from, sanofi-aventis and Pfizer. M D Jensen is a consultant for sanofi-aventis, Metabolic Pharmaceuticals, Novartis, MetaCure, Shionogi USA, and Merck, and has also received grant support from the US National Institutes of Health. L F Van Gaal is a member of advisory boards for sanofi-aventis, Abbott Pharma, and E Lilly and Co. He has received lecture fees from sanofi-aventis and Abbott Pharma, and has grant support from Fonds voor Wetenschappelijk Onderzoek (Scientific Research Council, Flanders, Belgium).
PY - 2006/11/11
Y1 - 2006/11/11
N2 - Background: Rimonabant, a selective cannabinoid type 1 receptor blocker, reduces bodyweight and improves cardiovascular and metabolic risk factors in non-diabetic overweight or obese patients. The aim of the RIO-Diabetes trial was to assess the efficacy and safety of rimonabant in overweight or obese patients with type 2 diabetes that was inadequately controlled by metformin or sulphonylureas. Methods: 1047 overweight or obese type 2 diabetes patients (body-mass index 27-40 kg/m2) with a haemoglobin A1c (HbA1c) concentration of 6·5-10·0% (mean 7·3% [SD 0·9] at baseline) already on metformin or sulphonylurea monotherapy were given a mild hypocaloric diet and advice for increased physical activity, and randomly assigned placebo (n=348), 5 mg/day rimonabant (360) or 20 mg/day rimonabant (339) for 1 year. Two individuals in the 5 mg/day group did not receive double-blind treatment and were thus not included in the final analysis. The primary endpoint was weight change from baseline after 1 year of treatment. Analyses were done on an intention-to-treat basis. This trial is registered at ClinicalTrials.gov, number NCT00029848. Findings: 692 patients completed the 1 year follow-up; numbers in each group after 1 year were much the same. Weight loss was significantly greater after 1 year in both rimonabant groups than in the placebo group (placebo: -1·4 kg [SD 3·6]; 5 mg/day: -2·3 kg [4·2], p=0·01 vs placebo; 20 mg/day: -5·3 kg [5·2], p<0·0001 vs placebo). Rimonabant was generally well tolerated. The incidence of adverse events that led to discontinuation was slightly greater in the 20 mg/day rimonabant group, mainly due to depressed mood disorders, nausea, and dizziness. Interpretation: These data indicate that 20 mg/day rimonabant, in combination with diet and exercise, can produce a clinically meaningful reduction in bodyweight and improve HbA1c and a number of cardiovascular and metabolic risk factors in overweight or obese patients with type 2 diabetes inadequately controlled by metformin or sulphonylureas.
AB - Background: Rimonabant, a selective cannabinoid type 1 receptor blocker, reduces bodyweight and improves cardiovascular and metabolic risk factors in non-diabetic overweight or obese patients. The aim of the RIO-Diabetes trial was to assess the efficacy and safety of rimonabant in overweight or obese patients with type 2 diabetes that was inadequately controlled by metformin or sulphonylureas. Methods: 1047 overweight or obese type 2 diabetes patients (body-mass index 27-40 kg/m2) with a haemoglobin A1c (HbA1c) concentration of 6·5-10·0% (mean 7·3% [SD 0·9] at baseline) already on metformin or sulphonylurea monotherapy were given a mild hypocaloric diet and advice for increased physical activity, and randomly assigned placebo (n=348), 5 mg/day rimonabant (360) or 20 mg/day rimonabant (339) for 1 year. Two individuals in the 5 mg/day group did not receive double-blind treatment and were thus not included in the final analysis. The primary endpoint was weight change from baseline after 1 year of treatment. Analyses were done on an intention-to-treat basis. This trial is registered at ClinicalTrials.gov, number NCT00029848. Findings: 692 patients completed the 1 year follow-up; numbers in each group after 1 year were much the same. Weight loss was significantly greater after 1 year in both rimonabant groups than in the placebo group (placebo: -1·4 kg [SD 3·6]; 5 mg/day: -2·3 kg [4·2], p=0·01 vs placebo; 20 mg/day: -5·3 kg [5·2], p<0·0001 vs placebo). Rimonabant was generally well tolerated. The incidence of adverse events that led to discontinuation was slightly greater in the 20 mg/day rimonabant group, mainly due to depressed mood disorders, nausea, and dizziness. Interpretation: These data indicate that 20 mg/day rimonabant, in combination with diet and exercise, can produce a clinically meaningful reduction in bodyweight and improve HbA1c and a number of cardiovascular and metabolic risk factors in overweight or obese patients with type 2 diabetes inadequately controlled by metformin or sulphonylureas.
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U2 - 10.1016/S0140-6736(06)69571-8
DO - 10.1016/S0140-6736(06)69571-8
M3 - Article
C2 - 17098084
AN - SCOPUS:33751001942
VL - 368
SP - 1660
EP - 1672
JO - The Lancet
JF - The Lancet
SN - 0140-6736
IS - 9548
ER -