Authors' objectives:

This review aims to assess systematically the clinical effectiveness and cost-effectiveness of sibutramine in the management of obesity.

Authors' results and conclusions: Most of the individual placebo-controlled trials and pooled estimates suggested that sibutramine produced statistically significant greater weight loss than placebo at all observed endpoints (weighted mean difference for weight change at 8 weeks: -3.4 kg; mean difference range for weight change at 6 months: -4.0 to -9.1 kg; and at 1 year: -4.1 to -4.8 kg). The most frequent dosing regimen was 10-20 mg daily. Findings suggested a dose-effect relationship in terms of weight loss. Sibutramine was also associated with better weight maintenance relative to placebo (statistically significant difference). Results from mainly small trials showed that sibutramine produced more favourable outcomes in terms of loss of fat mass, reduction in body mass index and loss of at least 5% and 10% of initial body weight. Between-group differences for waist circumference, hip circumference and waisthip ratio did not reach statistical significance in most trials. Similar results for weight loss were found in trials recruiting solely patients with type-2 diabetes; between-group differences for changes in indicators of glycaemic control were not usually statistically significant. Sibutramine use was associated with small, statistically significant increases in pulse rate, heart rate and blood pressure. The cost per QALY was estimated as 10,500 GBP.

Authors' recommendations: Although many trials demonstrated statistically significant differences between groups in terms of weight loss in favour of sibutramine versus placebo, the differences may not always be of clinical significance. The clinical significance of between-group differences for secondary outcomes may also be debatable. Possible adverse effects should be taken into account when prescribing sibutramine.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.hta.ac.uk/1297

Year Published: 2002

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

Copyright: 2009 Queen's Printer and Controller of HMSO