{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,20]],"date-time":"2025-10-20T18:02:17Z","timestamp":1760983337182},"reference-count":19,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2012,9,6]],"date-time":"2012-09-06T00:00:00Z","timestamp":1346889600000},"content-version":"vor","delay-in-days":859,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Obesity"],"published-print":{"date-parts":[[2010,5]]},"abstract":"<jats:p>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\u2010week, single\u2010blind, lead\u2010in period between patients who conformed to the label requirements (\u201cconformers\u201d) and those who did not (\u201cnonconformers\u201d). SCOUT is an ongoing, randomized, double\u2010blind, placebo\u2010controlled 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\u2010in 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 &gt;145\/90 mm Hg, were nonconformers. Conformers and nonconformers had similar reductions in body weight (median change \u22122.2 kg) and waist circumference (women: \u22122.0 cm for both groups; men: \u22121.5 cm vs. \u22122.0 cm for conformers and nonconformers, respectively) over the 6\u2010week period. Greater blood pressure falls were evident in nonconformers (median change \u22123.5\/\u22121.0 vs. \u22121.0\/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 \u223c93% of patients in both groups completed the 6\u2010week period. The SCOUT lead\u2010in period evaluating weight management with sibutramine confirms its good tolerability and efficacy in patients who meet current label criteria. Preliminary data from high\u2010risk 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.<\/jats:p>","DOI":"10.1038\/oby.2009.327","type":"journal-article","created":{"date-parts":[[2009,10,8]],"date-time":"2009-10-08T10:31:44Z","timestamp":1254997904000},"page":"987-994","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Early Response to Sibutramine in Patients Not Meeting Current Label Criteria: Preliminary Analysis of SCOUT Lead\u2010in Period"],"prefix":"10.1002","volume":"18","author":[{"given":"Ian","family":"Caterson","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Walmir","family":"Coutinho","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nick","family":"Finer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luc","family":"Van Gaal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aldo","family":"Maggioni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Torp\u2010Pedersen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arya M.","family":"Sharma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hong","family":"Ge","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donatella","family":"Santoro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gillian","family":"Shepherd","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philip","family":"James","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"SCOUT Investigators","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,9,6]]},"reference":[{"key":"e_1_2_7_2_2","unstructured":"World Health Organization.Obesity in Europe<http:www.euro.who.intobesity> (2007)."},{"key":"e_1_2_7_3_2","unstructured":"Centers for Disease Control and Prevention.US Obesity Trends 1985\u20132007<http:www.cdc.govnccdphpdnpaobesitytrendmapsindex.htm> (2008)."},{"key":"e_1_2_7_4_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.295.13.1549"},{"issue":"2","key":"e_1_2_7_5_2","first-page":"51S","article-title":"National Institutes of Health","volume":"6","author":"Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults\u2014The Evidence Report","year":"1998","journal-title":"Obes Res"},{"key":"e_1_2_7_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)03491-7"},{"key":"e_1_2_7_7_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa050156"},{"key":"e_1_2_7_8_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1463-1326.2000.00071.x"},{"key":"e_1_2_7_9_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1467-789X.2007.00425.x"},{"key":"e_1_2_7_10_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehm217"},{"key":"e_1_2_7_11_2","doi-asserted-by":"publisher","DOI":"10.1097\/FJC.0b013e31818713d6"},{"key":"e_1_2_7_12_2","first-page":"505","article-title":"Sibutramine Clinical Study 1047 Team. 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