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NICE has published a Final Appraisal Determination (FAD) for rimonabant▼ for the treatment of overweight and obese patients.
In the Appraisal Consultation Document, published in December 2007, the Appraisal Committee stated that it was minded not to recommend rimonabant for the treatment of obese and overweight adults. Further evidence on its cost effectiveness and effect on health outcomes (including cardiovascular risk factors) was requested from the manufacturer. This was highlighted in a previous blog. However, after receiving further information from the manufacturer and considering feedback from the consultation process, the Appraisal Committee recommended rimonabant for adults who have had an inadequate response to, are unable to tolerate, or have a contraindication to orlistat and sibutramine.
Subject to any appeal (period for appeal closes on 9th April 2008), the FAD may be used as the basis for the Institute’s guidance on rimonabant.
The FAD recommends rimonabant as follows:
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Rimonabant, within its licensed indications, is recommended as an adjunct to diet and exercise for adults who are obese or overweight and who have had an inadequate response to, are intolerant* of, or are contraindicated to orlistat and sibutramine.
*‘steatorrhoea’ as a consequence of not adhering to dietary advice should not be considered as intolerance to orlistat.
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Rimonabant treatment should be continued beyond 6 months only if the person has lost at least 5% of their initial body weight since starting rimonabant treatment.
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Rimonabant treatment should be discontinued if a person returns to their original weight while on rimonabant treatment.
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Rimonabant treatment should not be continued for longer than 2 years without a formal clinical assessment and discussion of the individual risks and benefits with the person receiving treatment.
The Appraisal Committee discussed the adverse effects of rimonabant, especially those linked to alterations in mood and psychiatric symptoms. The potential rimonabant has for adversely affecting people’s mood was a significant concern, especially given the known association between obesity and depression. They noted that rimonabant should not be prescribed to people with uncontrolled psychiatric illnesses and that treatment should be stopped if the person develops depression. The Committee agreed with specialists that people should be assessed for such conditions before treatment with rimonabant is started, and that people should be monitored during treatment for the emergence of signs of depression or other mood disorders.
The psychiatric side effects of rimonabant have been discussed in more detail in a previous blog and the March edition of MeReC Extra, No 32. A meta-analysis of four randomised controlled trials of rimonabant versus placebo (12 to 24 months duration) found that the number needed to harm (NNH) for withdrawals due to depression was 49, and for anxiety this was 166 [1].
Action
The recommendations in the Final Appraisal Determination on rimonabant do not yet constitute final NICE guidance, and this should be referred to once available. NICE clinical guideline 43 on obesity should also be taken into account. We would advise caution, careful counseling of patients and full recording of that discussion in the patient’s notes before prescribing a medicine that increases depression sufficient for one patient in every 49 patients to stop taking rimonobant. Prescribers should be alert to the increased risk of psychiatric side effects, and rimonabant must not be used by patients with major depression or those being treated with antidepressants. As rimonabant▼ is a “black triangle drug”, any incidences of suspected adverse reactions should be reported to the MHRA through the Yellow Card Scheme.
Reference
1. Christensen R, Kristensen PK, Bartels EM, et al. Efficacy and safety of the weight-loss drug rimonabant: a meta-analysis of randomised trials. Lancet 2007;370:1706–13 Accessed from www.thelancet.com/journals/lancet/article/PIIS0140673607617218/abstract on 27/03/08
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