Second-Generation Antipsychotic-Associated Serious Adverse Events in Women: An Analysis of a National Pharmacoepidemiologic Database.

IF 2.9 3区医学 Q2 PHARMACOLOGY & PHARMACY

Journal of Clinical Psychopharmacology Pub Date : 2025-03-01 DOI:10.1097/JCP.0000000000001962

Kenneth L McCall, Emily E Leppien, Brian J Piper, Bridgette M Falco, Kara K Fleck, Jacob C Govel, Gianna N Nasta, Steven R Zheng

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引用次数: 0

Abstract

Purpose: Women have historically been underrepresented in second-generation antipsychotic (SGA) clinical trials, accounting for less than 35% of participants, which raises concerns about the generalizability of the safety profile for these medications.

Methods: The US adverse event reporting system was queried for the dates January 1, 2019, to July 8, 2024, to examine the following 6 SGAs: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, and ziprasidone. Reports were excluded if patients were under 18 years old, contained an unknown age or gender, or were duplicated. Five adverse events were examined: Torsades de pointes (TdP), neuroleptic malignant syndrome (NMS), tardive dyskinesia (TD), agranulocytosis (AG), and cerebrovascular adverse events (CVAE). Counts of these events were noted, and reporting odds ratios (ROR) were calculated.

Results: The total study cohort was 87,356 reports, consisting of aripiprazole (n = 10,715, 12.2%), clozapine (n = 25,096, 28.7%), olanzapine (n = 11,587, 13.3%), quetiapine (n = 28,746, 32.9%), risperidone (n = 10,467, 12%), and ziprasidone (n = 745, 0.9%). The cohort's mean age was 48.6 ± 18.5 years and comprised 42,584 females (48.7%). Most cases were reported by healthcare professionals (74,836, 85.7%). A total of 3,754 reports contained at least 1 of the 5 adverse events. The RORs among females compared to males for TdP (5.55, 95% confidence interval [CI] = 3.78-8.47), NMS (0.59, 95% CI = 0.53-0.65), TD (0.88, 95% CI = 0.76-1.02), AG (0.59, 95% CI = 0.51-0.70), and CVAE (1.12, 95% CI = 0.89-1.41) were observed. Females had a significantly higher odds of hospitalization or death with TdP compared to males (ROR = 3.09, 95% CI = 1.36-7.01).

Conclusions: Our findings suggest higher odds of TdP and worse TdP-associated outcomes among females exposed to SGAs compared to males. Further studies are needed to confirm these preliminary findings.

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女性第二代抗精神病药物相关严重不良事件：国家药物流行病学数据库分析。

目的：女性在第二代抗精神病药（SGA）临床试验中的代表性不足，占参与者的比例不到35%，这引起了对这些药物安全性概况的普遍性的担忧。方法：查询2019年1月1日至2024年7月8日美国不良事件报告系统，检查以下6种SGAs：阿立哌唑、氯氮平、奥氮平、喹硫平、利培酮和齐拉西酮。如果患者年龄在18岁以下，包含未知年龄或性别，或重复的报告被排除。研究了5种不良事件：关节畸形（TdP）、抗精神病药恶性综合征（NMS）、迟发性运动障碍（TD）、粒细胞缺乏症（AG）和脑血管不良事件（CVAE）。记录这些事件的计数，并计算报告的优势比（ROR）。结果：总研究队列87,356份报告，包括阿立哌唑（n = 10,715, 12.2%）、氯氮平（n = 25,096, 28.7%）、奥氮平（n = 11,587, 13.3%）、喹硫平（n = 28,746, 32.9%）、利培酮（n = 10,467, 12%）和齐拉西酮（n = 745, 0.9%）。该队列的平均年龄为48.6±18.5岁，包括42584名女性（48.7%）。大多数病例由卫生保健专业人员报告（74,836例，85.7%）。总共3754份报告至少包含5种不良事件中的1种。观察女性与男性在TdP（5.55, 95%可信区间[CI] = 3.78 ~ 8.47）、NMS （0.59, 95% CI = 0.53 ~ 0.65）、TD （0.88, 95% CI = 0.76 ~ 1.02）、AG （0.59, 95% CI = 0.51 ~ 0.70）和CVAE （1.12, 95% CI = 0.89 ~ 1.41）方面的相对误差（RORs）。与男性相比，女性因TdP住院或死亡的几率明显更高（ROR = 3.09, 95% CI = 1.36-7.01）。结论：我们的研究结果表明，与男性相比，暴露于SGAs的女性发生TdP的几率更高，TdP相关结果更差。需要进一步的研究来证实这些初步发现。

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

Journal of Clinical Psychopharmacology 医学-精神病学

CiteScore

4.00

自引率

3.40%

发文量

231

审稿时长

4-8 weeks

期刊介绍： Journal of Clinical Psychopharmacology, a leading publication in psychopharmacology, offers a wide range of articles reporting on clinical trials and studies, side effects, drug interactions, overdose management, pharmacogenetics, pharmacokinetics, and psychiatric effects of non-psychiatric drugs. The journal keeps clinician-scientists and trainees up-to-date on the latest clinical developments in psychopharmacologic agents, presenting the extensive coverage needed to keep up with every development in this fast-growing field.