Sexual Dysfunction with Antipsychotics: Emerging Clues from a Disproportionality Analysis of the World Health Organization VigiBase.

IF 5.9 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2026-09-01 Epub Date: 2026-04-14 DOI:10.1007/s40264-026-01673-7

Efstathios Pavlidis, Spyridon Siafis, Elena Arzenton, Salvatore Crisafulli, Emanuel Raschi, Ugo Moretti, Andrea M Isidori, Emmanuele A Jannini, Gianluca Trifirò, Erich Seifritz, Corrado Barbui, Chiara Gastaldon, Georgios Schoretsanitis

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引用次数: 0

Abstract

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^® 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 .

查看原文本刊更多论文

抗精神病药的性功能障碍：来自世界卫生组织维格数据库的不相称性分析的新线索。

导读：抗精神病药物相关的性不良反应（adr）在临床实践中是众所周知的，尽管了解抗精神病药物和不同类型的性不良反应之间的差异的努力有限。目的：本研究的目的是评估和优先考虑每种抗精神病药在性不良反应报告方面的概况，并考虑潜在的混杂因素。方法：我们使用VigiBase®进行病例/非病例研究，使用定制的抗精神病药物相关性不良反应的临床指导搜索策略。报告优势比（ROR）和贝叶斯信息分量（IC）与相关的95%置信区间（95% ci）被用作不成比例度量来识别不成比例报告（SDRs）的信号。将抗精神病药物与所有其他药物及噻嗪类药物（阳性对照）进行比较。敏感性分析包括非严重报告，排除可能混淆的联合用药患者，排除青少年和老年患者，并包括共同报告的高泌乳素血症病例。分析按性别分层。采用定性和定量标准对抗精神病药物进行临床优先级排序。结果：我们纳入了5195例抗精神病药物相关性不良反应（43.1%为严重不良反应，中位发病时间为61天，36.1%为医师报告）。在所有抗精神病药物类别中，男性（勃起功能障碍[3487篇报道；ROR 2.49, 95% CI 2.40-2.57]；阴茎勃起[2372篇报道；ROR 15.55, 95% CI 14.82-16.32]）和女性（性欲下降[373篇报道；ROR 1.61, 95% CI 1.46-1.79]）都出现了一些特别反应，除了女性的毒虫碱拮抗剂（ROR 0.64, 95% CI 0.55-0.73; IC - 0.65, 95% CI - 0.86 - 0.45）。在两性中，报告最多的是利培酮、阿立哌唑和奥氮平。在敏感性分析中，仅包括非严重病例和合并高泌乳素血症的病例，sdr消失。所有抗精神病药物的性不良反应被归类为中等优先级，但氟吡林（低优先级）除外。结论：尽管存在局限性，包括无法推断因果关系，但这些发现提出了一种假设，即性不良反应可能是抗精神病药物的一类效应，但可能在女性和男性中都是可逆的。注册：该协议已注册到开放科学框架：https://osf.io/96eq7。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.