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Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects
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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.)
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“Early weight loss medications, such as fenfluramine (Fen-Phen) and sibutramine, were withdrawn due to severe cardiovascular and psychiatric side effects [3,4].”
From Obesity: Clinical Impact, Pathophysiology, Complications, and Modern Innovations in Therapeutic Strategies (2025) · cites this paper as [4]
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“Despite 5–10% weight loss in trials, it was discontinued in 2010 after the SCOUT trial showed elevated cardiovascular events (e.g., stroke) in high-risk patients [4].”
From Obesity: Clinical Impact, Pathophysiology, Complications, and Modern Innovations in Therapeutic Strategies (2025) · cites this paper as [4]
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“the concept of treating obesity to reduce the risk of cardiovascular complications has been hampered by the lack of evidence from trials indicating that lifestyle or pharmacologic interventions for overweight or obesity improve cardiovascular outcomes. 11-15”
From Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (2023) · cites this paper as [13]
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“Prospective studies that evaluated the effect of nonsurgical weight loss interventions on CV event reduction have been disappointing [4, 5, 6, 7, 8].”
From Semaglutide for cardiovascular event reduction in people with overweight or obesity: SELECT study baseline characteristics (2023) · cites this paper as [5]
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“Specifically, across the obesity CVOTs, SELECT is the only study to our knowledge that only enrolled participants with established CVD, whereas in the other obesity CVOTs, 24.9% to 50.5% of participants had no prior events [5, 6, 7, 8].”
From Semaglutide for cardiovascular event reduction in people with overweight or obesity: SELECT study baseline characteristics (2023) · cites this paper as [5]
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Metadata
- Authors
- 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.
- Affiliations
- London School of Hygiene & Tropical Medicine (GB)
- The University of Sydney (AU)
- Pontifícia Universidade Católica do Rio de Janeiro (BR)
- University College London (GB)
- Associazione Nazionale Medici Cardiologi Ospedalieri (IT)
- Gentofte Hospital (DK)
- University of Alberta (CA)
- Abbott (United States) (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-09-02
- Volume
- 363
- Issue
- 10
- Pages
- 905-917
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2119779723
- Cited by
- 943
- References
- 33
- Citations by year
- 2026: 27 · 2025: 43 · 2024: 50 · 2023: 40 · 2022: 35 · 2021: 50 · 2020: 45 · 2019: 36 · 2018: 54 · 2017: 38 · 2016: 63 · 2015: 69 · 2014: 75 · 2013: 91 · 2012: 93
- FWCI
- 75.02
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- UCrea (University of Cantabria) (submittedVersion, cc-by)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- CINECA IRIS Institutial research information system (University of Pisa) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, other-oa)
- ORBi (University of Liège) (submittedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Funders
- Abbott Laboratories
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- University of Cambridge
- Eisai
- Novo Nordisk
- Shionogi
- Servier
- Allergan
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
- Keywords
- sibutramine, cardiovascular outcomes, obesity, overweight, weight management, cardiovascular risk, myocardial infarction, stroke, cardiovascular mortality, type 2 diabetes, blood pressure, weight loss, older adults, drug safety, appetite suppressants, anti-obesity drugs, cardiovascular events, cardiovascular risk reduction, cardiovascular risk stratification
- MeSH terms
- Aged, Appetite Depressants, Blood Pressure, Cardiovascular Diseases, Cyclobutanes, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Humans, Male, Middle Aged, Myocardial Infarction, Obesity, Stroke, Overweight, Kaplan-Meier Estimate
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