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.
RCT Entities:
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.
Authors: R V Seimon; D Espinoza; L Ivers; V Gebski; N Finer; U F Legler; A M Sharma; W P T James; W Coutinho; I D Caterson Journal: Int J Obes (Lond) Date: 2014-01-10 Impact factor: 5.095
Authors: Peter Weeke; Charlotte Andersson; Emil L Fosbøl; Bente Brendorp; Lars Køber; Arya M Sharma; Nick Finer; Philip T James; Ian D Caterson; Richard A Rode; Christian Torp-Pedersen Journal: BMC Endocr Disord Date: 2010-02-26 Impact factor: 2.763
Authors: L Busetto; M Mazza; S Salvalaio; F De Stefano; M Marangon; E Calò; S Sampietro; G Enzi Journal: Eat Weight Disord Date: 2009 Jun-Sep Impact factor: 4.652
Authors: Charlotte Andersson; Peter Weeke; Bente Brendorp; Lars Køber; Emil L Fosbøl; Arya M Sharma; Nick Finer; Ian D Caterson; Richard A Rode; Philip T James; Christian Torp-Pedersen Journal: Nutr Metab (Lond) Date: 2009-10-14 Impact factor: 4.169