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

Abstract

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 145/90mmHg, were nonconformers. Conformers and nonconformers had similar reductions in body weight (median change 2.2kg) and waist circumference (women: 2.0cm for both groups; men: 1.5cm vs. 2.0cm 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. 1.0/0.0mmHg). Both groups had small pulse rate increases; median 1.5bpm (nonconformers) vs. 3.0bpm (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. © 2010 The Obesity Society.