News: Sibutramine approved for obesity by NICE

The Pharmaceutical Journal Vol 267 No 7170 p537-541
20 October 2001

Sibutramine approved for obesity by NICE

Sibutramine (Reductil) should be available as an option for the management of obesity, the National Institute for Clinical Excellence (NICE) said in guidance issued on 15 October.

NICE recommends that sibutramine should be prescribed for two groups of people who have made previous serious attempts to lose weight: those who have a body mass index of 30kg/m² or more, and those with a BMI of 27kg/m² or more and significant co-morbidities (eg, type 2 diabetes, high cholesterol). The drug should be prescribed only as part of an overall treatment plan that should include advice, support and counselling on diet, and monitoring of weight loss and adverse effects (including blood pressure monitoring since sibutramine may increase blood pressure).

The starting dose of sibutramine recommended by NICE is 10mg a day, increased to 15mg a day after four weeks. Therapy should only be continued after four weeks if the patient has lost at least 2kg of weight, and only beyond three months if the patient has lost at least 5 per cent of their initial body weight. Sibutramine should be used for a maximum of 12 months. Over three years, NICE estimates that the approximate total costs for sibutramine (drug and monitoring costs) will be £19.2m.

NICE points out that further research into the longer-term impact of sibutramine needs to be addressed including how quickly weight is regained after sibutramine therapy is stopped and the effect of using sibutramine for longer than 12 months. A randomised controlled trial comparing sibutramine, orlistat and behavioural therapy is also needed, it adds.

Sibutramine is a noradrenaline and serotonin re-uptake inhibitor. The guidance is available on the NICE website (www.nice.org.uk).