麻豆传媒

PHILADELPHIA -- In postmenopausal women, treatment with the controversial drug flibanserin (Addyi) was effective for the treatment of hypoactive sexual desire disorder (HSDD), researchers reported here from a manufacturer-sponsored study.

The post-hoc analysis of the trial found a total score improvement in the Female Sexual Function Index (FSFI) with flibanserin treatment versus placebo of 1.5 points (SE 0.5, P=0.01), according to lead author Sheryl A. Kingsberg, PhD, of Case Western Reserve University in Cleveland, and colleagues.

Presented at the annual meeting of , five of the six domains measured in the FSFI improved, marked by significant changes in least-squares mean differences after 24-weeks of treatment compared to placebo:

• Desire: 0.3 (SE 0.1), P<0.0001
• Arousal: 0.3 (SE 0.1), P=0.003
• Lubrication: 0.2 (SE 0.1), P=0.044
• Orgasm: 0.2 (SE 0.1), P=0.044
• Satisfaction: 0.3 (SE 0.1), P=0.004

Only pain did not significantly improve from baseline among the flibanserin group.

Flibanserin, a mixed 5-HT1A agonist/5-HT2A antagonist, is currently FDA approved for the treatment of premenopausal women with acquired, generalized HSDD, marked by a combination of reduced sexual desire and subsequent personal distress. Whether the agent has any beneficial effect in postmenopausal women has been less certain. (Indeed, its effectiveness in the premenopausal population has been questioned, despite the FDA approval.)

HSDD is the most prevalent sexual dysfunction among all ages of women, with about 1 in 10 women being afflicted, Kingsberg told 麻豆传媒.

Scores on the self-reported Female Sexual Function Index (FSFI) range from 2-36, with a 26 or higher indicating sexual dysfunction.

This analysis included a total of 895 individuals – 432 on 100 mg flibanserin at bedtime daily and 463 on placebo. All participants were diagnosed with HSDD at least 6 months prior to the study, according to the DSM-IV-TR criteria, and those not meeting this criteria were excluded.

The ideal candidate for a pharmacologic option like flibanserin is someone with a recognized drop in sexual desire from a previously satisfactory level, and they miss it, Kingsberg explained.

"I think it's very important that clinicians who are not familiar with sexual medicine recognize that women very much want to talk about their sexual concerns, and that it is critically important to their health and quality of life," she highlighted, adding that not all women know recognize this to be a medical condition for which there is treatment for.

"So it is up to the clinician to ask, and I promise it will not take up their entire 15-minute office visit," she suggested. "If they use something like the [Decreased Sexual Desire Screener], if they ask an open-ended question, 'what sexual concerns do you have' -- most of my patients have some -- they can do that effectively and efficiently within 2 minutes, and it improves adherence to whatever treatment you come up with and patient satisfaction with the visit."

Kingsberg added that she has hopes for this pharmacologic treatment in postmenopausal women. "Unfortunately there's nothing that is FDA approved for postmenopausal women, yet," she said.

Comment