PD20-08 INVESTIGATION OF SEXUAL DYSFUNCTION LINKED TO FINASTERIDE USE: A PHARMACOVIGILANCE ANALYSIS

Abstract

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy I (PD20)1 Sep 2021PD20-08 INVESTIGATION OF SEXUAL DYSFUNCTION LINKED TO FINASTERIDE USE: A PHARMACOVIGILANCE ANALYSIS David-Dan Nguyen, Peter Herzog, Eugene B Cone, Logan Briggs, Khalid Alkhatib, Shehzad Basaria, Dean S Elterman, Quoc-Dien Trinh, and Naeem Bhojani David-Dan NguyenDavid-Dan Nguyen More articles by this author , Peter HerzogPeter Herzog More articles by this author , Eugene B ConeEugene B Cone More articles by this author , Logan BriggsLogan Briggs More articles by this author , Khalid AlkhatibKhalid Alkhatib More articles by this author , Shehzad BasariaShehzad Basaria More articles by this author , Dean S EltermanDean S Elterman More articles by this author , Quoc-Dien TrinhQuoc-Dien Trinh More articles by this author , and Naeem BhojaniNaeem Bhojani More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002009.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Finasteride, a 5α-reductase inhibitor, is used in the management of alopecia and benign prostatic hyperplasia (BPH). Previous reports suggest that some men taking finasteride experience a constellation of adverse events, including sexual dysfunction. We investigated the association of sexual dysfunction with finasteride use METHODS: We conducted a pharmacovigilance study using VigiBase, the World Health Organization's global database of individual case safety reports. We used the reporting odds ratio (ROR), a surrogate measure of association used in disproportionality analysis, with 95% confidence intervals (CI). Extensive sensitivity analyses included stratifying by indication (BPH and alopecia) and age (<45 and ≥45); comparing finasteride signals to those of drugs with different mechanisms but similar indications (minoxidil for alopecia and tamsulosin for BPH); comparing finasteride to a drug with a similar mechanism of action (dutasteride); and comparing reports of sexual dysfunction before and after 2012. RESULTS: We identified 7700 reports of sexual dysfunction in finasteride users. There was a significant disproportionality signal for sexual dysfunction (ROR 50.30, 95% CI 49.03-51.60) linked to finasteride use. All sensitivity analyses met the threshold of signal significance (Table 1). Patients under the age of 45 (ROR 65.73, 95% CI 61.83-69.88) and alopecia patients (ROR 33.62, 95% CI 25.22-44.82) had larger signals than older patients (ROR 30.43, 95% CI 27.12-34.15) and those with BPH (ROR 1.74, 95% CI 1.47-2.07). A signal was detected for minoxidil (ROR 1.92, 95% CI 1.54-2.38). CONCLUSIONS: We detected disproportional signals of sexual dysfunction linked with finasteride use. Despite sexual dysfunction being more prevalent in older BPH patients, we detected larger signals of sexual dysfunction in young alopecia patients. Sensitivity analyses suggest that reports of sexual dysfunction linked with finasteride use may be confounded by indication (young alopecia patients may be more likely to experience sexual dysfunction) and by stimulated reporting. However, confounding alone does not account for the totality of the signal observed in young patients with alopecia considering the large difference in signal size between finasteride and minoxidil. Source of Funding: none © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e370-e370 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information David-Dan Nguyen More articles by this author Peter Herzog More articles by this author Eugene B Cone More articles by this author Logan Briggs More articles by this author Khalid Alkhatib More articles by this author Shehzad Basaria More articles by this author Dean S Elterman More articles by this author Quoc-Dien Trinh More articles by this author Naeem Bhojani More articles by this author Expand All Advertisement Loading ...