Early Response to Sibutramine in Patients Not Meeting Current Label Criteria: Preliminary Analysis of SCOUT Lead‐in Period |
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| Authors: | Ian Caterson Walmir Coutinho Nick Finer Luc Van Gaal Aldo Maggioni Christian Torp‐Pedersen Arya M Sharma Hong Ge Donatella Santoro Gillian Shepherd Philip James SCOUT Investigators |
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| Institution: | 1. Institute of Obesity, Nutrition and Exercise, University of Sydney, Sydney, New South Wales, Australia;2. Endocrinology, Obesity and Eating Disorders Research Group, Catholic University of Rio de Janeiro, Rio de Janeiro, Brazil;3. Division of Bariatric Medicine and Surgery, University College London, London, UK;4. Department of Diabetology, Metabolism and Clinical Nutrition, University Hospital of Antwerp, Antwerp, Belgium;5. ANMCO Research Center, Florence, Italy;6. Department of Cardiology, Bispebjerg University Hospital Copenhagen, Copenhagen, Denmark;7. Department of Cardiovascular Obesity Research and Management, University of Alberta, Edmonton, Alberta, Canada;8. Abbott Laboratories, Abbott Park, Illinois, USA;9. London School of Hygiene and Tropical Medicine, London, UK |
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| 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 >145/90 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. |
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