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Cardiovascular responses to weight management and sibutramine in high-risk subjects: an analysis from the SCOUT trial

Christian Torp-Pedersen, Ian Caterson, Walmir Coutinho, Nick Finer, Luc Van Gaal, Aldo Maggioni, Arya Sharma, Wygenia Brisco, Roger Deaton, Gillian Shepherd, Philip James
DOI: http://dx.doi.org/10.1093/eurheartj/ehm217 2915-2923 First published online: 26 June 2007

Abstract

Aims The Sibutramine Cardiovascular OUTcomes (SCOUT) trial is a randomized, double-blind comparison of sibutramine vs. placebo, in addition to standard care for weight management, in overweight/obese subjects with an increased risk of cardiovascular disease. The study had an initial single-blind, 6-week lead-in period with sibutramine plus weight management. We report the cardiovascular responses and weight loss during this period.

Methods and results A total of 10 742 subjects received treatment in the lead-in period; 97% had cardiovascular disease, 88% hypertension and 84% type 2 diabetes. Body weight decreased (median 2.2 kg [5th, 95th percentile changes −6.2, 0.5]); waist circumference was reduced by 2.0 cm (men: −8.5, 2.9; women: −9.0, 3.0), systolic blood pressure fell by 3.0 mmHg (−23.5, 12.5) and diastolic by 1.0 mmHg (−13.5, 10.0). Pulse rate increased by 1.5 b.p.m. (−11.0, 13.5). All changes were statistically significant (P < 0.001). Two consecutive increases in blood pressure or pulse rate of >10 mmHg/b.p.m. were observed in 4.7 and 3.5% of subjects, respectively. Fifteen subjects (0.1%) died; 10 deaths were attributed to a cardiovascular cause, equivalent to 1.2 and 0.8 deaths per 100 years of exposure, respectively.

Conclusion Six-week treatment with sibutramine appears to be efficacious, tolerable and safe in this high-risk population for whom sibutramine is usually contraindicated.

Keywords
  • Sibutramine
  • Randomized trial
  • Cardiovascular outcomes
  • Weight loss
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