Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects

W Philip T James; Ian D Caterson; Walmir Coutinho; Nick Finer; Luc F Van Gaal; Aldo P Maggioni; Christian Torp-Pedersen; Arya M Sharma; Gillian M Shepherd; Richard A Rode; Cheryl L Renz; SCOUT Investigators; Maria Helena Dominguez Vall-Lamora; Hans Jørgen Duckert Perrild

doi:10.1056/NEJMoa1003114

Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects

W Philip T James, Ian D Caterson, Walmir Coutinho, Nick Finer, Luc F Van Gaal, Aldo P Maggioni, Christian Torp-Pedersen, Arya M Sharma, Gillian M Shepherd, Richard A Rode, Cheryl L Renz, SCOUT Investigators, Maria Helena Dominguez Vall-Lamora, Hans Jørgen Duckert Perrild

609 Citationer (Scopus)

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.)

Originalsprog	Engelsk
Tidsskrift	New England Journal of Medicine
Vol/bind	363
Udgave nummer	10
Sider (fra-til)	905-17
Antal sider	13
ISSN	0028-4793
DOI	https://doi.org/10.1056/NEJMoa1003114 https://doi.org/10.1056/NEJMoa1003114
Status	Udgivet - 2 sep. 2010

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James, W. P. T., Caterson, I. D., Coutinho, W., Finer, N., Van Gaal, L. F., Maggioni, A. P., Torp-Pedersen, C., Sharma, A. M., Shepherd, G. M., Rode, R. A., Renz, C. L., SCOUT Investigators, Dominguez Vall-Lamora, M. H., & Perrild, H. J. D. (2010). Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. New England Journal of Medicine, 363(10), 905-17. https://doi.org/10.1056/NEJMoa1003114, https://doi.org/10.1056/NEJMoa1003114

James, WPT, Caterson, ID, Coutinho, W, Finer, N, Van Gaal, LF, Maggioni, AP, Torp-Pedersen, C, Sharma, AM, Shepherd, GM, Rode, RA, Renz, CL, SCOUT Investigators, Dominguez Vall-Lamora, MH & Perrild, HJD 2010, 'Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects', New England Journal of Medicine, bind 363, nr. 10, s. 905-17. https://doi.org/10.1056/NEJMoa1003114, https://doi.org/10.1056/NEJMoa1003114

@article{bb31fceda54247b7bb8595ea4459c47a,

title = "Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects",

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.)",

keywords = "Aged, Appetite Depressants, Blood Pressure, Cardiovascular Diseases, Cyclobutanes, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction, Obesity, Overweight, Stroke",

author = "James, {W Philip T} and Caterson, {Ian D} and Walmir Coutinho and Nick Finer and {Van Gaal}, {Luc F} and Maggioni, {Aldo P} and Christian Torp-Pedersen and Sharma, {Arya M} and Shepherd, {Gillian M} and Rode, {Richard A} and Renz, {Cheryl L} and Torp-Pedersen, {Christian Tobias} and {Dominguez Vall-Lamora}, {Maria Helena} and Perrild, {Hans J{\o}rgen Duckert}",

year = "2010",

month = sep,

day = "2",

doi = "10.1056/NEJMoa1003114",

language = "English",

volume = "363",

pages = "905--17",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "10",

}

TY - JOUR

T1 - Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects

AU - James, W Philip T

AU - Caterson, Ian D

AU - Coutinho, Walmir

AU - Finer, Nick

AU - Van Gaal, Luc F

AU - Maggioni, Aldo P

AU - Torp-Pedersen, Christian

AU - Sharma, Arya M

AU - Shepherd, Gillian M

AU - Rode, Richard A

AU - Renz, Cheryl L

AU - SCOUT Investigators

AU - Dominguez Vall-Lamora, Maria Helena

AU - Perrild, Hans Jørgen Duckert

PY - 2010/9/2

Y1 - 2010/9/2

N2 - 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.)

AB - 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.)

KW - Aged

KW - Appetite Depressants

KW - Blood Pressure

KW - Cardiovascular Diseases

KW - Cyclobutanes

KW - Diabetes Mellitus, Type 2

KW - Double-Blind Method

KW - Female

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Myocardial Infarction

KW - Obesity

KW - Overweight

KW - Stroke

U2 - 10.1056/NEJMoa1003114

DO - 10.1056/NEJMoa1003114

M3 - Journal article

C2 - 20818901

SN - 0028-4793

VL - 363

SP - 905

EP - 917

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 10

ER -

Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects

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