1 / 1 Efficacy and safety of flibanserin to treat women with ‘hypoactive sexual desire disorder’; a meta- analysis Nr 5 | 2016 (50) | Page 60-61 | New | 21-05-2016 The authors of the meta-analysis discussed here conclude that treating women with ‘hypoactive sexual desire disorder’ (HSDD) with flibanserin results in an average of half an additional satisfactory sexual experience a month. The drug has to be taken daily and therefore has daily side-effects. Flibanserin was statistically significantly more effective than placebo, but its clinical relevance was small (1 additional point on a scale of 84; 6 additional satisfactory sexual experiences a year). The differences in side-effects were also statistically significant and were also clinically relevant. Sexual dysfunction often has multifactorial causes, and medical interventions should be evaluated with this in mind. Unduly high expectations of using a ‘pill’, whether blue or red, are unjustified. FDA staff have defended their decision to authorise flibanserin by saying that women can try for themselves whether improvements to their sexual experiences caused by the drug outweigh the risks of side-effects. 3 Nevertheless, not only the efficacy of flibanserin but also its safety appear to have so far been insufficiently established, as studies have been of doubtful methodological quality and involved a selected healthy population. The present meta-analysis confirms that its effect in terms of increasing sexual desire is minimal. References* 1. Diagnostic and Statistical Manual of mental disorders. DSM-IV. Washington DC: American Psychiatric Association, 1994. 2. American Psychiatric Association. Handboek voor de classificatie van psychische stoornissen DSM-5. Amsterdam: Boom, 2014. 3. Borsini F, et al. Pharmacology of flibanserine. CNS Drug Rev 2002; 8: 117-142. 4. Joffe HV, et al. FDA approval of flibanserin-treating hypoactive sexual desire disorder. N Engl J Med 2016; 374: 101-104. 5. Jaspers L, et al. Efficacy and safety of flibanserin for the treatment of hyposexual desire disorder in women: a systematic review and meta-analysis. JAMA Intern Med 2016; doi: 10.1001/jamainternmed.2015.8565. 6. Woloshin S, et al. US FDA approval of fibranserin: even the score does not add up [editorial]. JAMA Intern Med 2016; doi: 10.1001/jamainternmed.2016.0073. *The literature refers to the Dutch text Copyright © 2022 Ge-Bu. Alle rechten voorbehouden. | https://www.ge-bu.nl

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Page 1: Efficacy and safety of flibanserin to treat women with

1 / 1

Efficacy and safety of flibanserin to treat womenwith ‘hypoactive sexual desire disorder’; a meta-analysisNr 5 | 2016 (50) | Page 60-61 | New | 21-05-2016

The authors of the meta-analysis discussed here conclude that treating women with ‘hypoactive sexual desire disorder’(HSDD) with flibanserin results in an average of half an additional satisfactory sexual experience a month. The drug hasto be taken daily and therefore has daily side-effects. Flibanserin was statistically significantly more effective thanplacebo, but its clinical relevance was small (1 additional point on a scale of 84; 6 additional satisfactory sexualexperiences a year). The differences in side-effects were also statistically significant and were also clinically relevant.Sexual dysfunction often has multifactorial causes, and medical interventions should be evaluated with this in mind.Unduly high expectations of using a ‘pill’, whether blue or red, are unjustified. FDA staff have defended their decision toauthorise flibanserin by saying that women can try for themselves whether improvements to their sexual experiencescaused by the drug outweigh the risks of side-effects.3 Nevertheless, not only the efficacy of flibanserin but also itssafety appear to have so far been insufficiently established, as studies have been of doubtful methodological quality andinvolved a selected healthy population. The present meta-analysis confirms that its effect in terms of increasing sexualdesire is minimal.

References*

1. Diagnostic and Statistical Manual of mental disorders. DSM-IV. Washington DC: American Psychiatric Association,1994.

2. American Psychiatric Association. Handboek voor de classificatie van psychische stoornissen DSM-5. Amsterdam:Boom, 2014.

3. Borsini F, et al. Pharmacology of flibanserine. CNS Drug Rev 2002; 8: 117-142.4. Joffe HV, et al. FDA approval of flibanserin-treating hypoactive sexual desire disorder. N Engl J Med 2016; 374:

101-104.5. Jaspers L, et al. Efficacy and safety of flibanserin for the treatment of hyposexual desire disorder in women: a

systematic review and meta-analysis. JAMA Intern Med 2016; doi: 10.1001/jamainternmed.2015.8565.6. Woloshin S, et al. US FDA approval of fibranserin: even the score does not add up [editorial]. JAMA Intern Med

2016; doi: 10.1001/jamainternmed.2016.0073.

*The literature refers to the Dutch text