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Clinical Studies and Practice

Changes in body weight and pulse: outcome events in overweight and obese subjects with cardiovascular disease in the SCOUT trial

International Journal of Obesity volume 39, pages 849–857 (2015)Cite this article

Subjects

Abstract

Background/Objectives:

The Sibutramine Cardiovascular OUTcomes (SCOUT) trial showed a significantly increased relative risk of nonfatal cardiovascular events, but not mortality, in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise. We examined the relationship between early changes (both increases and decreases) in pulse rate, and the impact of these changes on subsequent cardiovascular outcome events in both the placebo and sibutramine groups.

Subjects/Methods:

9804 males and females, aged ⩾55 years, with a body mass index of 27–45 kg m−2 were included in this current subanalysis of the SCOUT trial. Subjects were required to have a history of cardiovascular disease and/or type 2 diabetes mellitus with at least one cardiovascular risk factor, to assess cardiovascular outcomes. The primary outcome event (POE) was a composite of nonfatal myocardial infarction, nonfatal stroke, resuscitated cardiac arrest or cardiovascular death. Time-to-event analyses of the POE were performed using Cox regression models.

Results:

During the initial 6-week sibutramine treatment period, the induced pulse rate increase was related to weight change (1.9±7.7 beats per minute (bpm) with weight increase; 1.4±7.3 bpm, 0–5 kg weight loss; 0.6±7.4 bpm, ⩾5 kg weight loss). Throughout the subsequent treatment period, those continuing on sibutramine showed a consistently higher mean pulse rate than the placebo group. There was no difference in POE rates with either an increase or decrease in pulse rate over the lead-in period, or during lead-in baseline to 12 months post randomization. There was also no relationship between pulse rate at lead-in baseline and subsequent cardiovascular events in subjects with or without a cardiac arrhythmia.

Conclusion:

Baseline pulse rate and changes in pulse rate may not be an important modifier nor a clinically useful predictor of outcome in an individual elderly cardiovascular obese subject exposed to weight management.

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Acknowledgements

The original trial was supported and funded by Abbott Laboratories (Abbott Park, IL, USA). The Executive Steering Committee designed the study in cooperation with the sponsor. RVS was supported by a National Health and Medical Research Council of Australia Early Career Research Fellowship (no 1072771). We are also grateful to the Endocrine Society of Australia for a Postdoctoral Award to RVS.

Disclaimer

The authors have full access to all data, determined the analyses, are solely responsible for its interpretation and this manuscript without reference to the original sponsor and took the final decision to submit the manuscript for publication.

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Authors and Affiliations

  1. The Boden Institute of Obesity, Nutrition Exercise & Eating Disorders, University of Sydney, Sydney, New South Wales, Australia

    R V Seimon, A Sweeting & I D Caterson

  2. National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia

    D Espinoza & V Gebski

  3. National Centre for Cardiovascular Prevention and Outcomes, University College London, Institute for Cardiovascular Science, London, UK

    N Finer

  4. London School of Hygiene and Tropical Medicine, London, UK

    W P T James

  5. Special Vocational College for Handicapped Persons, Mainz, Germany

    U F Legler

  6. Catholic University of Rio de Janeiro and State Institute of Diabetes and Endocrinology, Rio de Janeiro, Brazil

    W Coutinho

  7. Department of Medicine, University of Alberta, Edmonton, Alberta, Canada,

    A M Sharma

  8. Department of Diabetology, Metabolism and Clinical Nutrition, Antwerp University Hospital, Antwerp, Belgium

    L Van Gaal

  9. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy

    A P Maggioni

  10. Department of Cardiology, Gentofte University Hospital, Hellerup, Denmark

    C Torp-Pedersen

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  1. R V Seimon
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Corresponding author

Correspondence to R V Seimon.

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Competing interests

NF: member of SCOUT Executive Steering Committee (ESC) received payments from Abbott, as advisor for Novo Nordisk, Merck, sanofi-aventis, GlaxoSmithKline and Shionogi, consultant for Ajinomoto, and provided expert testimony for sanofi-aventis, Vivus, Arena and received a grant from GlaxoSmithKline. WPTJ: Chair of the SCOUT ESC received payment from Abbott; the International Association for the Study of Obesity when he was the President also received a grant from Novo Nordisk. UFL: was an employee of Abbott with equity interest in the Company. WC: member of the SCOUT ESC received payments from Abbott Laboratories, lecture fees and/or travel reimbursement from Abbott, Ache Laboratorios Farmaceuticos S/A, Roche and Novo Nordisk, as advisor for Abbott, Ache Laboratorios Farmaceuticos S/A, GSK, Novo Nordisk, Takeda and Roche, and provided expert testimony for Abbott. AMS: member of the SCOUT ESC received payment from Abbott Laboratories, and as advisor for Abbott, Merck, Arena, Novo Nordisk, sanofi-aventis, GlaxoSmithKline, Boehringer Ingelheim, and NeuroSearch, as consultant for Vivus and Allegan, provided expert testimony for GlaxoSmithKline, received grants from Abbott and Covidian. LVG: Received a research grant from National Research Funds, Belgium; served on the speaker's bureaus of Sanofi-Aventis and Abbott; served as a consultant to Amylin Pharmaceuticals, Sanofi-Aventis, Eli Lilly, and Abbott; member of SCOUT ESC receiving payment from Abbott. IDC: member of SCOUT ESC received payment from Abbott Laboratories, royalties from Wiley-Blackwell as co-editor of an obesity textbook, and the Boden Institute of Obesity, Nutrition and Exercise received grants from Novo Nordisk, sanofi-aventis, Pfizer (Australia), Weight Watchers, Allergan and the Korean Ministry of Agriculture. The remaining authors declare no conflict of interest.

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Seimon, R., Espinoza, D., Finer, N. et al. Changes in body weight and pulse: outcome events in overweight and obese subjects with cardiovascular disease in the SCOUT trial. Int J Obes 39, 849–857 (2015). https://doi.org/10.1038/ijo.2014.211

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