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Preliminary recommendations from NICE reject rimonabant
The NICE Appraisal Committee has developed preliminary recommendations on the use of rimonabant for the treatment of overweight and obese adults, which state that it is currently minded not to recommend its use.
It advised that further clarification is requested from the manufacturer of rimonabant, regarding:
- Evidence from the clinical trials on health outcomes (including cardiovascular risk factors) of adults who responded to treatment with rimonabant
- Evidence on the cost effectiveness of rimonabant compared with diet and exercise alone, and compared with orlistat and sibutramine, including assessment of:
- The application of a 5% weight loss continuation rule to treatment with rimonabant at 3, 6, 9 and 12 months
- The application of a discontinuation rule to treatment with rimonabant should an adult develop signs of depression or return to their original weight while on treatment for more than 1 year
- The impact of adverse events on health-related quality of life, particularly those relating to depressive disorders
- The costs of assessing people for depression before starting therapy with rimonabant, and monitoring people for weight loss and possible depression during treatment with rimonabant
- Alternative assumptions to reflect that treatment effects at 1 year are likely to deteriorate over time while receiving rimonabant treatment.
Action
Caution is necessary before prescribing rimonabant for the treatment of patients with obesity. As reported in a previous blog on November 19th 2007, advice from the MHRA in July 2007 warned that rimonabant must not be used by patients with major depression or those being treated with antidepressants, because of the risk of psychiatric side effects. Prescribers are reminded to observe the recommendations and contraindications for the use of rimonabant as detailed in the summary of product information (http://www.medicines.org.uk/) and to report any incidences of adverse reactions suspected to be related to its use to the MHRA through its Yellow Card scheme.
The recommendations made by the NICE Appraisal Committee in the appraisal consultation document do not constitute NICE guidance on rimonabant. They are preliminary and may change. The closing date for comments is 7th January 2008 and the second appraisal committee meeting will take place on 5th February 2008.
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