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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.

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 …