Early response to sibutramine in patients not meeting current label criteria: preliminary analysis of SCOUT lead-in period.
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.
Caterson
Ian
I
Institute of Obesity, Nutrition and Exercise, University of Sydney, Sydney, New South Wales, Australia. Ian.Caterson@usyd.edu.au
Coutinho
Walmir
W
Finer
Nick
N
Van Gaal
Luc
L
Maggioni
Aldo
A
Torp-Pedersen
Christian
C
Sharma
Arya M
AM
Ge
Hong
H
Santoro
Donatella
D
Shepherd
Gillian
G
James
Philip
P
D000368:Aged; D001067:Appetite Depressants / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D003503:Cyclobutanes / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D018579:Patient Selection; D018570:Risk Assessment; D012307:Risk Factors; D016037:Single-Blind Method; D016896:Treatment Outcome
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine