Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects

James, W. Philip T., Caterson, Ian D., Coutinho, Walmir, Finer, Nick, Van Gaal, Luc F., Maggioni, Aldo P., Torp-Pedersen, Christian, Sharma, Arya M., Shepherd, Gillian M., Rode, Richard A., Renz, Cheryl L., SCOUT Investigators and Colquhoun, David (2010) Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. New England Journal of Medicine, 363 10: 905-917. doi:10.1056/NEJMoa1003114

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Author James, W. Philip T.
Caterson, Ian D.
Coutinho, Walmir
Finer, Nick
Van Gaal, Luc F.
Maggioni, Aldo P.
Torp-Pedersen, Christian
Sharma, Arya M.
Shepherd, Gillian M.
Rode, Richard A.
Renz, Cheryl L.
SCOUT Investigators
Colquhoun, David
Title Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
Publication date 2010-09-02
Year available 2010
Sub-type Article (original research)
DOI 10.1056/NEJMoa1003114
Open Access Status File (Publisher version)
Volume 363
Issue 10
Start page 905
End page 917
Total pages 13
Place of publication Waltham, MA, United States
Publisher Massachusetts Medical Society
Language eng
Subject 2700 Medicine
Abstract Background: The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established. Methods: We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death). Results: The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.31; P = 0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P = 0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P = 0.03). The rates of cardiovascular death and death from any cause were not increased. Conclusions: Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; ClinicalTrials.gov number, NCT00234832.) Copyright
Keyword Medicine, General & Internal
General & Internal Medicine
Q-Index Code CX
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
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