R V Seimon1, D Espinoza2, N Finer3, W P T James4, U F Legler5, W Coutinho6, A M Sharma7, L Van Gaal8, A P Maggioni9, A Sweeting1, C Torp-Pedersen10, V Gebski2, I D Caterson1. 1. The Boden Institute of Obesity, Nutrition Exercise & Eating Disorders, University of Sydney, Sydney, New South Wales, Australia. 2. National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia. 3. National Centre for Cardiovascular Prevention and Outcomes, University College London, Institute for Cardiovascular Science, London, UK. 4. London School of Hygiene and Tropical Medicine, London, UK. 5. Special Vocational College for Handicapped Persons, Mainz, Germany. 6. Catholic University of Rio de Janeiro and State Institute of Diabetes and Endocrinology, Rio de Janeiro, Brazil. 7. Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. 8. Department of Diabetology, Metabolism and Clinical Nutrition, Antwerp University Hospital, Antwerp, Belgium. 9. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy. 10. Department of Cardiology, Gentofte University Hospital, Hellerup, Denmark.
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.
RCT Entities:
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.
Authors: Marie Therese Cooney; Erkki Vartiainen; Tiina Laatikainen; Tinna Laakitainen; Anne Juolevi; Alexandra Dudina; Ian M Graham Journal: Am Heart J Date: 2010-04 Impact factor: 4.749
Authors: 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 Journal: N Engl J Med Date: 2010-09-02 Impact factor: 91.245
Authors: A R Dyer; V Persky; J Stamler; O Paul; R B Shekelle; D M Berkson; M Lepper; J A Schoenberger; H A Lindberg Journal: Am J Epidemiol Date: 1980-12 Impact factor: 4.897
Authors: T C Andrews; T Fenton; N Toyosaki; S P Glasser; P M Young; G MacCallum; R S Gibson; T L Shook; P H Stone Journal: Circulation Date: 1993-07 Impact factor: 29.690
Authors: Belén Picatoste; Elisa Ramírez; Alicia Caro-Vadillo; Cristian Iborra; Sara Ares-Carrasco; Jesús Egido; José Tuñón; Oscar Lorenzo Journal: PLoS One Date: 2013-10-21 Impact factor: 3.240