Brexpiprazole for agitation in alzheimer's disease: A systematic review and meta-analysis of randomized controlled trials.

IF 2 4区医学 Q3 PSYCHIATRY

Indian Journal of Psychiatry Pub Date : 2025-09-01 Epub Date: 2025-09-16 DOI:10.4103/indianjpsychiatry_197_25

João Vitor Andrade Fernandes, João Victor de Oliveira Ramos, Laís Araújo Dos Santos Vilar, Maurus Marques de Almeida Holanda

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引用次数: 0

Abstract

Background: Agitation in Alzheimer's disease (AD) severely affects patients and caregivers. Brexpiprazole, a serotonin-dopamine modulator, is the potential treatment; however, recent trials and variations in dosing have raised questions about its optimal efficacy and safety.

Aim: To evaluate the efficacy and safety of brexpiprazole in the treatment of agitation associated with AD, with a focus on dose-specific outcomes.

Methods: A systematic search was conducted in PubMed, Embase, and the Cochrane Library for Randomized Controlled Trials (RCT) comparing brexpiprazole with placebo in AD-related agitation. Primary efficacy outcomes included changes in the Cohen-Mansfield Agitation Inventory (CMAI) and Clinical Global Impression-Severity (CGI-S) scores. Safety outcomes encompassed treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and mortality. Meta-analyses were performed using a random-effects model, with mean differences (MD) and odds ratios (OR) reported with 95% confidence intervals (CI).

Results: Four RCTs with 1,710 participants were included. Brexpiprazole 2 mg significantly reduced CMAI scores (MD: -5.618; 95% CI: -7.884, -3.351; P < 0.001) and CGI-S scores (MD: -0.513; 95% CI: -0.890, -0.135; P = 0.008) compared to placebo. Lower doses (0.5-1 mg) demonstrated limited efficacy. TEAEs were more frequent with brexpiprazole 2 mg (OR: 1.554; 95% CI: 1.045, 2.312; P = 0.030), while SAEs (OR: 1.389; P = 0.384) and mortality (OR: 2.189; P = 0.301) did not significantly differ from placebo.

Conclusion: Brexpiprazole 2 mg is effective in reducing agitation symptoms in AD with an acceptable safety profile.

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布雷哌唑治疗阿尔茨海默病的躁动：随机对照试验的系统回顾和荟萃分析。

背景：阿尔茨海默病（AD）的躁动严重影响患者和护理人员。Brexpiprazole是一种血清素-多巴胺调节剂，是一种潜在的治疗方法；然而，最近的试验和剂量的变化对其最佳疗效和安全性提出了质疑。目的：评价brexpiprazole治疗AD相关躁动的疗效和安全性，重点关注剂量特异性结局。方法：在PubMed、Embase和Cochrane随机对照试验库（RCT）中进行系统检索，比较brexpiprazole和placebo在ad相关躁动中的作用。主要疗效指标包括Cohen-Mansfield躁动量表（CMAI）和临床总体印象严重程度（CGI-S）评分的变化。安全性指标包括治疗中出现的不良事件（teae）、严重不良事件（sae）和死亡率。采用随机效应模型进行meta分析，平均差异（MD）和优势比（OR）报告，95%置信区间（CI）。结果：纳入4项随机对照试验，共1710名受试者。与安慰剂相比，Brexpiprazole 2mg显著降低CMAI评分（MD: -5.618; 95% CI: -7.884, -3.351; P < 0.001）和CGI-S评分（MD: -0.513; 95% CI: -0.890, -0.135; P = 0.008）。较低剂量（0.5-1 mg）的效果有限。brexpiprazole 2mg组的teae发生率更高（OR: 1.554; 95% CI: 1.045, 2.312; P = 0.030），而SAEs （OR: 1.389; P = 0.384）和死亡率（OR: 2.189; P = 0.301）与安慰剂组无显著差异。结论：布雷吡拉唑2mg可有效减轻AD患者的躁动症状，且安全性可接受。

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

Indian Journal of Psychiatry Medicine-Psychiatry and Mental Health

CiteScore

4.40

自引率

3.20%

发文量

130

审稿时长

34 weeks

期刊介绍： The Indian Journal of Psychiatry (ISSN 0019-5545), is an official publication of the Indian Psychiatric Society. It is published Bimonthly with one additional supplement (total 5 issues). The IJP publishes original work in all the fields of psychiatry. All papers are peer-reviewed before publication. The issues are published Bimonthly. An additional supplement is also published annually. Articles can be submitted online from www.journalonweb.com . The journal provides immediate free access to all the published articles. The journal does not charge the authors for submission, processing or publication of the articles.