39 Onset of Flibanserin Treatment Effect in Postmenopausal Women Assessed by Subdomain Scores of the Female Sexual Function Index (FSFI)
Notice bibliographique
Résumé
ABSTRACT Introduction Flibanserin, a treatment for acquired, generalized hypoactive sexual desire disorder (HSDD), is approved in the US for use in certain premenopausal women and in Canada for use in both premenopausal and naturally postmenopausal women ≤60 years of age. Improvement in symptoms following initiation of flibanserin may take several weeks to emerge and it is important to set realistic expectations of treatment onset. Objective The primary objective of this analysis was to evaluate the onset of flibanserin's treatment effect in naturally postmenopausal women with HSDD across the 6 subdomains of the FSFI. Methods A post-hoc analysis was conducted using FSFI data from a randomized, controlled, double-blind trial of flibanserin in naturally postmenopausal women with HSDD that included 895 postmenopausal women (flibanserin, n=432; placebo, n=463) who had at least one on-treatment efficacy assessment. The FSFI is a validated, 19-item self-report questionnaire comprising 6 subdomains of sexual functioning: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each subdomain has a maximum score of 6 and higher scores indicate better sexual functioning. For each subdomain, change from baseline at each assessment visit (4, 8, 16, and 24 weeks) was calculated as the least squares mean difference. Comparisons between flibanserin and placebo groups were performed using analysis of covariance. Results Postmenopausal patients treated with flibanserin had significantly greater sexual desire and arousal scores than those treated with placebo at Week 4 and at every assessment timepoint thereafter (see figure). By Week 8, patients in the flibanserin group had significantly higher scores for all FSFI subdomains compared to the placebo group. This treatment effect was maintained at Week 24 for all subdomains except for pain. Conclusions Results from this post-hoc analysis indicates that postmenopausal women treated with flibanserin experienced improved sexual function compared to those treated with placebo with regard to sexual desire, arousal, lubrication, orgasm and satisfaction. This improvement was maintained over the entire course of treatment. These findings are consistent with those from a previous FSFI post-hoc analysis of clinical trial data from premenopausal women and suggest that flibanserin treatment of postmenopausal women was associated with improvement of multiple aspects of sexual function in addition to sexual desire. Disclosure Yes, this is sponsored by industry/sponsor: Sprout Pharmaceuticals, Inc. Clarification Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Sprout Pharmaceuticals, Inc.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».