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Title
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Early response to sibutramine in patients not meeting current label criteria: preliminary analysis of SCOUT lead-in period
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Author
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Institution/Organisation
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SCOUT Investigators
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Abstract
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| 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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Language
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English
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Source (journal)
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Obesity. - Silver Spring, Md
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Publication
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Silver Spring, Md
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2010
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ISSN
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1930-7381
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DOI
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10.1038/OBY.2009.327
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Volume/pages
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18
:5
(2010)
, p. 987-994
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ISI
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000277234800023
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Full text (Publisher's DOI)
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