European Heart Journal Advance Access published online on June 26, 2007
European Heart Journal, doi:10.1093/eurheartj/ehm217
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Cardiovascular responses to weight management and sibutramine in high-risk subjects: an analysis from the SCOUT trial
1 Department of Cardiology, Bispebjerg University Hospital, Bispebjerg Bakke 23, Copenhagen 2400 NV, Denmark
2 University of Sydney, Sydney, Australia
3 Catholic University of Rio de Janeiro, Rio de Janeiro, Brazil
4 Wellcome Trust Clinical Research Facility, Cambridge University, Cambridge, UK
5 University Hospital of Antwerp, Antwerp, Belgium
6 ANMCO Research Center, Florence, Italy
7 McMaster University Hospital, Hamilton, Ontario, Canada
8 Abbott Laboratories, Abbott Park, IL, USA
9 London School of Hygiene and Tropical Medicine, London, UK
Received 30 November 2006; revised 6 March 2007; accepted 3 May 2007; online publish-ahead-of-print .
* Corresponding author. Tel: +45 356 316 161; fax: +45 3976 0107. E-mail address: ctp{at}heart.dk
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.
Key Words: Sibutramine • Randomized trial • Cardiovascular outcomes • Weight loss
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  S. von Haehling, M. Lainscak, and S. D. Anker Sibutramine in cardiovascular disease: is SCOUT the new STORM on the horizon? Eur. Heart J., December 1, 2007; 28(23): 2830 - 2831. [Full Text] [PDF]
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