| アブストラクト | INTRODUCTION: Antipsychotic-associated sexual adverse drug reactions (ADRs) are well known in clinical practice, although efforts to understand differences between antipsychotics and distinct types of sexual ADRs are limited. OBJECTIVE: The aim of this study was to assess and prioritize the profile of each antipsychotic regarding sexual ADRs reporting, and to account for potential confounders. METHODS: We used VigiBase((R)) to conduct a case/non-case study using a customized clinically guided search strategy of antipsychotic-related sexual ADRs. The reporting odds ratio (ROR) and Bayesian information component (IC) with relevant 95% confidence intervals (95% CIs) were used as disproportionality measures to identify signals of disproportionate reporting (SDRs). Antipsychotics were compared with all other drugs and with thiazides (positive control). Sensitivity analyses included non-serious reports, excluding patients with potentially confounding co-medication(s), excluding adolescent and elderly patients, and including cases with co-reported hyperprolactinemia. Analyses were stratified by sex. Antipsychotics were ranked in terms of clinical priority using qualitative and quantitative criteria. RESULTS: We included 5195 cases of antipsychotic-related sexual ADRs (43.1% serious, median time to onset of 61 days, 36.1% physician-reported). Several SDRs emerged in males (erectile dysfunction [3487 reports; ROR 2.49, 95% CI 2.40-2.57]; priapism [2372 reports; ROR 15.55, 95% CI 14.82-16.32]) and females (decreased libido [373 reports; ROR 1.61, 95% CI 1.46-1.79]) for all antipsychotic classes, except for muscarinic antagonists in females (ROR 0.64, 95% CI 0.55-0.73; IC - 0.65, 95% CI - 0.86 to - 0.45). In both sexes, the highest number of reports were for risperidone, aripiprazole and olanzapine. The SDRs disappeared in the sensitivity analysis including only non-serious cases and cases with co-reported hyperprolactinemia. Sexual ADRs for all antipsychotics were classified as of moderate priority, with the exception of fluspirilene (low priority). CONCLUSIONS: Notwithstanding limitations, including inability to infer causality, these findings raise the hypothesis that sexual ADRs could be a class effect of antipsychotics, yet possibly reversible, in both women and men. REGISTRATION: The protocol is registered to the Open Science Framework: https://osf.io/96eq7 . |
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| 投稿者 | Pavlidis, Efstathios; Siafis, Spyridon; Arzenton, Elena; Crisafulli, Salvatore; Raschi, Emanuel; Moretti, Ugo; Isidori, Andrea M; Jannini, Emmanuele A; Trifiro, Gianluca; Seifritz, Erich; Barbui, Corrado; Gastaldon, Chiara; Schoretsanitis, Georgios |
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| 組織名 | Psychiatric University Hospital Zurich, Department of Psychiatry, Psychotherapy;and Psychosomatics, University of Zurich, Zurich, Switzerland.;Department of Clinical Pharmacology and Toxicology, University Hospital Zurich,;Zurich, Switzerland.;TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy,;Technical University of Munich, Munich, Germany.;Deutsches Zentrum fur Psychische Gesundheit, Munchen-Augsburg, Germany.;Section of Pharmacology, Department of Diagnostics and Public Health, University;of Verona, Verona, Italy.;Pharmacology Unit, Department of Medical and Surgical Sciences, University of;Bologna, Bologna, Italy.;Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.;Chair of Endocrinology and Medical Sexology (ENDOSEX), Department of Biomedicine;and Prevention, University of Rome Tor Vergata, Rome, Italy.;Department of Neurosciences, Biomedicine and Movement Sciences, Section of;Psychiatry, University of Verona, WHO Collaborating Centre for Research and;Training in Mental Health and Service Evaluation, Piazzale L.A. Scuro, 10, 37134,;Verona, Italy.;Institute of Social and Preventive Medicine and Graduate School for Health;Sciences, University of Bern, Bern, Switzerland.;george.schor@gmail.com.;Department of Psychiatry, The Zucker Hillside Hospital, Behavioral Health;Pavilion, Northwell Health, 75-59 263rd Street, Glen Oaks, NY, 11004, USA.;Zucker School of Medicine at Northwell/Hofstra, Hempstead, NY, USA.;Department of Psychiatry, Unit of Pharmacogenetics and Clinical;Psychopharmacology, Centre for Psychiatric Neuroscience, Lausanne University;Hospital, University of Lausanne, Prilly, 1008, Lausanne, Switzerland. |
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