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

Ian Caterson; Walmir Coutinho; Nick Finer; Luc Van Gaal; Aldo Maggioni; Christian Torp-Pedersen; Arya M Sharma; Hongyou Ge; Donatella Santoro; Gillian Shepherd; Philip James Douglass; SCOUT Investigators

doi:10.1038/oby.2009.327

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

Ian Caterson, Walmir Coutinho, Nick Finer, Luc Van Gaal, Aldo Maggioni, Christian Torp-Pedersen, Arya M Sharma, Hongyou Ge, Donatella Santoro, Gillian Shepherd, Philip James Douglass, SCOUT Investigators

15 Citations (Scopus)

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.

Original language	English
Journal	Obesity
Volume	18
Issue number	5
Pages (from-to)	987-94
Number of pages	8
ISSN	1930-7381
DOIs	https://doi.org/10.1038/oby.2009.327
Publication status	Published - 1 May 2010

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title = "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 >145/90 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.",

author = "Ian Caterson and Walmir Coutinho and Nick Finer and {Van Gaal}, Luc and Aldo Maggioni and Christian Torp-Pedersen and Sharma, {Arya M} and Hongyou Ge and Donatella Santoro and Gillian Shepherd and Douglass, {Philip James} and Torp-Pedersen, {Christian Tobias}",

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doi = "10.1038/oby.2009.327",

language = "English",

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T1 - Early response to sibutramine in patients not meeting current label criteria: preliminary analysis of SCOUT lead-in period

AU - Caterson, Ian

AU - Coutinho, Walmir

AU - Finer, Nick

AU - Van Gaal, Luc

AU - Maggioni, Aldo

AU - Torp-Pedersen, Christian

AU - Sharma, Arya M

AU - Ge, Hongyou

AU - Santoro, Donatella

AU - Shepherd, Gillian

AU - Douglass, Philip James

AU - SCOUT Investigators

PY - 2010/5/1

Y1 - 2010/5/1

N2 - 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.

AB - 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.

U2 - 10.1038/oby.2009.327

DO - 10.1038/oby.2009.327

M3 - Journal article

SN - 1930-7381

VL - 18

SP - 987

EP - 994

JO - Obesity

JF - Obesity

IS - 5

ER -

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

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