Authors' objectives:

To provide guidance on the use of sibutramine for the treatment of obesity in adults.

Authors' recommendations: Guidance 1.1 Sibutramine should be prescribed only as part of an overall treatment plan for management of nutritional obesity in people aged 18-65 years who meet one of the following criteria: 1.1.1 a body mass index (BMI) of 27.0 kg/m2 or more in the presence of significant co-morbidities 1.1.2 a BMI of 30.0 kg/m2 or more without associated comorbidities. 1.2 Sibutramine should be prescribed, in accordance with the Summary of Product Characteristics, only for people who have made previous serious attempts to lose weight by diet, exercise and/or other behavioural modifications. 1.3 When treatment with sibutramine is offered, arrangements should be made for appropriate health professionals to offer specific concomitant advice, support and counselling on diet, physical activity and behavioural strategies. Sibutramine should not be prescribed unless adequate arrangements for monitoring both weight loss and adverse effects can be made available. 1.4 The starting dose of sibutramine should normally be 10 mg/day. Continuation of this therapy beyond 4 weeks should be supported by evidence of a 2 kg weight loss, and beyond 3 months should be supported by evidence of a loss of at least 5% of initial body weight from the start of drug treatment. Dosage may be increased to 15 mg/day after 4 weeks in line with sibutramine's Summary of Product Characteristics, and the same treatment and monitoring regimens followed as for the 10 mg/day dose. Sibutramine therapy should be stopped if there is inadequate response, as defined above. 1.5 Since the use of sibutramine may increase blood pressure of some individuals, blood pressure must be checked regularly in all those to whom it is prescribed. If blood pressure increases, continuation of sibutramine therapy must be reconsidered taking into account the risks and benefits of the effects of treatment on cardiovascular risk profile for the individual. Treatment with sibutramine is not recommended for individuals whose blood pressure before start of therapy is above 145/90 mm Hg. Treatment should be discontinued in people whose blood pressure rises above 145/90 mm Hg or by more than 10 mm Hg (systolic or diastolic) or whose resting pulse rate rises by more than 10 beats per minute. 1.6 Treatment is not recommended beyond the licensed indication of 12 months. 1.7 There is no evidence to support the co-prescribing of sibutramine with other pharmacotherapy aimed at weight reduction.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.nice.org.uk/cat.asp?c=23003

Year Published: 2001

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: National Institute for Clinical Excellence

Contact Address: MidCity Place, 71 High Holborn, London WC1V 6NA, UK. Tel: +44 020 7067 5800; Fax: +44 020 7067 5801

Contact Name: nice@nice.nhs.uk

Contact Email: nice@nice.nhs.uk

Copyright: National Institute for Clinical Excellence (NICE)