Age and Sex Differences in Adverse Events Associated With Antipsychotics: An Analysis of the FDA Adverse Events Database

IF 2.8 3区医学 Q2 GERIATRICS & GERONTOLOGY

International Journal of Geriatric Psychiatry Pub Date : 2025-08-15 DOI:10.1002/gps.70142

Tabea Ramin, Jens-Uwe Peter, Michael Schneider, Volker Dahling, Oliver Zolk

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引用次数: 0

Abstract

Objectives

While the risks of antipsychotics in older adults are well recognized, clinical trials often exclude frail older patients, have short follow-up periods, and provide limited comparative data on specific drugs. This study aimed to explore age-related differences in the adverse effects of six commonly prescribed antipsychotics using a pharmacovigilance database, with additional analysis of sex-based variations.

Methods

We analyzed adverse event (AE) reports associated with aripiprazole, clozapine, olanzapine, quetiapine, risperidone, and haloperidol from the FDA Adverse Event Reporting System (FAERS) database between Q4 2003 and Q2 2024. We utilized Standardized MedDRA Queries (SMQs) and self-defined queries to categorize 18 groups of AEs. Adjusted logistic regression was employed to calculate adjusted reporting odds ratios (aRORs) with 95% confidence intervals (CIs).

Results

Our analysis revealed substance-specific differences in AE profiles. Risperidone had the highest aROR for hyperprolactinemia (aROR 212, 95% CI 203–221), haloperidol for dystonia (aROR 46, 95% CI 41–51), and aripiprazole for akathisia (aROR 45, 95% CI 42–49). Patients aged 65 and older generally demonstrated a higher likelihood of experiencing cardiac, extrapyramidal motor, and sedative AEs compared to those under 65, with few exceptions across the drugs investigated. In contrast, younger patients showed higher odds for metabolic AEs, including dyslipidemia and hyperglycemia (associated with olanzapine and quetiapine), as well as weight gain (with olanzapine, quetiapine, risperidone, and haloperidol). With few exceptions, women generally showed higher reporting odds of adverse events. Sex-related differences were especially pronounced for hyperprolactinemia, with 4.7–8.0 times higher reporting odds in women for aripiprazole, olanzapine, quetiapine, and haloperidol—except for risperidone, where a post-2014 rise in male reports led to higher odds in men. Risperidone was also associated with increased reporting odds of weight gain in men. Additionally, aripiprazole and olanzapine showed 3 to 6 times higher reporting odds for anticholinergic syndrome in men compared to women.

Conclusions

It is essential to consider both age and sex in treatment decisions to optimize the efficacy and tolerability of antipsychotic therapy.

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抗精神病药物相关不良事件的年龄和性别差异：FDA不良事件数据库分析

虽然抗精神病药物对老年人的风险已得到充分认识，但临床试验往往排除体弱的老年患者，随访时间短，并且提供的特定药物的比较数据有限。本研究旨在利用药物警戒数据库探索六种常用抗精神病药物不良反应的年龄相关差异，并对基于性别的差异进行额外分析。方法分析2003年第四季度至2024年第二季度FDA不良事件报告系统（FAERS）数据库中与阿立哌唑、氯氮平、奥氮平、喹硫平、利培酮和氟哌啶醇相关的不良事件（AE）报告。我们使用标准化MedDRA查询（SMQs）和自定义查询对18组ae进行了分类。采用校正逻辑回归计算具有95%置信区间（ci）的校正报告优势比（aRORs）。结果我们的分析揭示了声发射谱的物质特异性差异。利培酮治疗高泌乳素血症的aROR最高（aROR 212, 95% CI 203-221），氟哌啶醇治疗肌张力障碍的aROR最高（aROR 46, 95% CI 41-51），阿立哌唑治疗静坐症的aROR最高（aROR 45, 95% CI 42-49）。与65岁以下的患者相比，65岁及以上的患者普遍表现出发生心脏、锥体外系运动和镇静剂ae的可能性更高，在所调查的药物中几乎没有例外。相反，年轻患者出现代谢性不良反应的几率更高，包括血脂异常和高血糖（与奥氮平和喹硫平相关），以及体重增加（与奥氮平、喹硫平、利培酮和氟哌啶醇相关）。除了少数例外，女性通常表现出较高的不良事件报告几率。高泌乳素血症的性别相关差异尤其明显，女性服用阿立哌唑、奥氮平、喹硫平和氟哌啶醇的报告几率是男性的4.7-8.0倍，但利培酮除外，2014年后男性报告的比例上升导致男性的风险更高。利培酮还与男性体重增加的报告几率增加有关。此外，阿立哌唑和奥氮平在男性患抗胆碱能综合征的几率比女性高3 - 6倍。结论在决定治疗方案时应同时考虑年龄和性别因素，以优化抗精神病药物的疗效和耐受性。

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

International Journal of Geriatric Psychiatry 医学-精神病学

CiteScore

6.10

自引率

2.50%

发文量

168

审稿时长

4-8 weeks

期刊介绍： The rapidly increasing world population of aged people has led to a growing need to focus attention on the problems of mental disorder in late life. The aim of the Journal is to communicate the results of original research in the causes, treatment and care of all forms of mental disorder which affect the elderly. The Journal is of interest to psychiatrists, psychologists, social scientists, nurses and others engaged in therapeutic professions, together with general neurobiological researchers. The Journal provides an international perspective on the important issue of geriatric psychiatry, and contributions are published from countries throughout the world. Topics covered include epidemiology of mental disorders in old age, clinical aetiological research, post-mortem pathological and neurochemical studies, treatment trials and evaluation of geriatric psychiatry services.