Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study

André J. Scheen, Nick Finer, Priscilla Hollander, Michael Dennis Jensen, Luc F. Van Gaal

Research output: Contribution to journalArticle

631 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1660-1672
Number of pages13
JournalLancet
Volume368
Issue number9548
DOIs
StatePublished - Nov 11 2006

Fingerprint

rimonabant
Type 2 Diabetes Mellitus
Placebos
Metformin
Hemoglobins
Cannabinoid Receptor Antagonists
Exercise
Diet
Dizziness
Mood Disorders

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes : a randomised controlled study. / Scheen, André J.; Finer, Nick; Hollander, Priscilla; Jensen, Michael Dennis; Van Gaal, Luc F.

In: Lancet, Vol. 368, No. 9548, 11.11.2006, p. 1660-1672.

Research output: Contribution to journalArticle

Scheen, André J. ; Finer, Nick ; Hollander, Priscilla ; Jensen, Michael Dennis ; Van Gaal, Luc F. / Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes : a randomised controlled study. In: Lancet. 2006 ; Vol. 368, No. 9548. pp. 1660-1672.
@article{b7e9970230874938a5cbac211caa3908,
title = "Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study",
abstract = "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.",
author = "Scheen, {Andr{\'e} J.} and Nick Finer and Priscilla Hollander and Jensen, {Michael Dennis} and {Van Gaal}, {Luc F.}",
year = "2006",
month = "11",
day = "11",
doi = "10.1016/S0140-6736(06)69571-8",
language = "English (US)",
volume = "368",
pages = "1660--1672",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "9548",

}

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 Dennis

AU - Van Gaal, Luc F.

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.

UR - http://www.scopus.com/inward/record.url?scp=33751001942&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33751001942&partnerID=8YFLogxK

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 -