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Early response to sibutramine in patients not meeting current label criteria: preliminary analysis of SCOUT lead-in period.

Author(s): Caterson I, Coutinho W, Finer N, Van Gaal L, Maggioni A, Torp-Pedersen C, Sharma AM, Ge H, Santoro D, Shepherd G, James P, SCOUT Investigators

Affiliation(s): Institute of Obesity, Nutrition and Exercise, University of Sydney, Sydney, New South Wales, Australia. Ian.Caterson@usyd.edu.au

Publication date & source: 2010-05, Obesity (Silver Spring)., 18(5):987-94. Epub 2009 Oct 8.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

The Sibutramine Cardiovascular Outcomes (SCOUT) trial protocol defines a patient population predominantly outside current European Union label criteria. This article explores responses to sibutramine during the 6-week, single-blind, lead-in period between patients who conformed to the label requirements ("conformers") and those who did not ("nonconformers"). SCOUT is an ongoing, randomized, double-blind, placebo-controlled outcome trial in overweight/obese patients at high risk of a cardiovascular event. In total, 10,742 patients received sibutramine and weight management during the lead-in period. Initial responses were assessed post hoc in label conformers and nonconformers. Of that 8.1% patients met label criteria; 91.9%, the majority with cardiovascular disease and/or blood pressure >145/90 mm Hg, were nonconformers. Conformers and nonconformers had similar reductions in body weight (median change -2.2 kg) and waist circumference (women: -2.0 cm for both groups; men: -1.5 cm vs. -2.0 cm for conformers and nonconformers, respectively) over the 6-week period. Greater blood pressure falls were evident in nonconformers (median change -3.5/-1.0 vs. -1.0/0.0 mm Hg). Both groups had small pulse rate increases; median 1.5 bpm (nonconformers) vs. 3.0 bpm (conformers). There was a low incidence of serious adverse events (conformers: 1.0%; nonconformers: 2.8%) and ~93% of patients in both groups completed the 6-week period. The SCOUT lead-in period evaluating weight management with sibutramine confirms its good tolerability and efficacy in patients who meet current label criteria. Preliminary data from high-risk patients for whom sibutramine is currently contraindicated suggest a low discontinuation rate and few serious adverse events but confirmation from the SCOUT outcome data is needed.

Page last updated: 2010-10-05

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