(036) Characterizing flibanserin’s safety profile among postmenopausal women with HSDD: An Exploratory Analysis
Notice bibliographique
Résumé
Abstract Introduction Flibanserin is approved in the United States (US) for premenopausal women and in Canada for pre and naturally postmenopausal women, ≤60 years of age, to treat acquired, generalized hypoactive sexual desire disorder (HSDD). Clinical trials suggest that flibanserin's safety profile is similar among pre-and postmenopausal women. During a Phase 3 postmenopausal study, the most frequently reported adverse events (AEs) were dizziness (10%), somnolence (9%), nausea (8%), and headache (6%). This study explores postmarketing AEs received from postmenopausal women and their clinicians during flibanserin treatment. Objective The primary objective of this safety study is to further characterize flibanserin's safety profile among postmenopausal women with HSDD treated in a clinical setting. Methods This study is a retrospective exploratory analysis of AEs captured in a global safety database (August 15, 2015, to May 12, 2022). The database was queried for US reports of AEs in postmenopausal women using the Medical Dictionary for Regulatory Activities Search Strategy Version 21.1. Preferred Term (PT) “Product use in unapproved indication.” This PT was selected as postmenopausal use is an unapproved indication in the US. Reports were filtered to identify and exclude non-postmenopausal unapproved usages, such as use in males and premenopausal women with non-HSDD conditions. All reports stating postmenopausal use are included in this analysis. If reproductive status was not specified, age was used as an indicator. If age was unknown, the report was excluded. The age range used in this study was 51-75 years. Adverse events were categorized using PTs, and descriptive statistics were used to summarize the results. Dispensing data from a sample of 30,000 scripts filled over the past year at one pharmacy were used to estimate the percentage of flibanserin prescriptions filled by women ages >50 years. No incidence data were calculated as AE reporting is voluntary and true exposure is unknown. Results We identified 195 unique reports of postmenopausal use with at least one AE during the study period. There were 656 reported AEs, 16 (2.4%) were serious, and no fatalities. Adverse events occurring in ≥5 postmenopausal women excluding events not related to a body system are summarized in the Figure. Approximately 18% of scripts filled over the past year at one pharmacy were for women ages >50 years. It is important to acknowledge that this pharmacy’s findings may not represent all pharmacies. Conclusions The postmarketing safety profile of flibanserin among postmenopausal women is similar to that observed with premenopausal women and during clinical trials. Excluding PTs not related to a body system such as unapproved use and drug ineffective, the most frequently reported postmarketing AEs included dizziness, nausea, and insomnia. No safety signals specific to postmenopausal women have been identified to date. Although informative, the lack of information on medical history, concomitant medications, and other potential interacting products limit the ability to make inferences on causality in most reported cases. 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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,001 | 0,002 |
| 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) | 0,001 | 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 tête enseignante, 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 ».