Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies.

C. Correll, Ying He, F. Therrien, Erin M Mackenzie, S. Meehan, C. Weiss, N. Hefting, M. Hobart
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引用次数: 3

Abstract

Objective: To evaluate the short- and long-term effects of brexpiprazole on patient functioning in schizophrenia. Methods: Data were included from three 6-week, randomized, double-blind, placebo-controlled studies (hospitalized patients); a 52-week, randomized, double-blind, placebo-controlled maintenance treatment study (terminated early by the study sponsor based on the positive result of an interim analysis); and two 52-week, open-label extension studies-all in patients with schizophrenia (DSM-IV-TR criteria) and conducted from July 2011-February 2016. Patients allocated to oral brexpiprazole received 2-4 mg/d (short-term studies) or 1-4 mg/d (long-term studies). Functioning was measured using the Personal and Social Performance (PSP) and Global Assessment of Functioning (GAF) scales, with response defined as a PSP/GAF increase of ≥ 10 points and remission as PSP score ≥ 71 or GAF score ≥ 61. Results: Patients receiving brexpiprazole (n = 831) showed greater improvement than those receiving placebo (n = 490) from baseline to week 6 in PSP score (least squares mean difference, 3.20; 95% confidence interval, 1.82-4.58; P < .0001; Cohen d = 0.31) and in all 4 PSP domains. At week 52 of the maintenance study (which had a low completion rate primarily due to the early termination), GAF functional remission was achieved by 65.3% (62/95) of stabilized patients randomized to brexpiprazole and 47.1% (48/102) of stabilized patients randomized to placebo, with a number needed to treat of 6 (95% confidence interval, 4-22; P = .0076). At week 52 of the open-label studies (n = 177), PSP functional response and remission were achieved by 84.2% and 41.8% of patients receiving brexpiprazole, respectively. Conclusions: Although limited by the lack of an active comparator, analyses of this large dataset demonstrate that brexpiprazole treatment is associated with clinically relevant improvement in functioning among patients with schizophrenia, in the short term and long term. Trial Registration: Data used in this post hoc analysis were from studies with ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380, NCT01668797, NCT01397786, and NCT01810783.
Brexpiprazole对精神分裂症患者功能的影响:短期和长期研究的事后分析
目的:评价布雷吡拉唑对精神分裂症患者功能的短期和长期影响。方法:数据来自3项为期6周的随机、双盲、安慰剂对照研究(住院患者);一项为期52周、随机、双盲、安慰剂对照的维持治疗研究(根据中期分析的阳性结果,研究发起人提前终止);以及2011年7月至2016年2月进行的两项为期52周的开放标签扩展研究,均为精神分裂症患者(DSM-IV-TR标准)。分配给口服brexpiprazole的患者接受2-4 mg/d(短期研究)或1-4 mg/d(长期研究)。使用个人和社会表现(PSP)和整体功能评估(GAF)量表来测量功能,反应定义为PSP/GAF增加≥10分,缓解定义为PSP评分≥71或GAF评分≥61。结果:从基线到第6周,接受brexpiprazole治疗的患者(n = 831)比接受安慰剂治疗的患者(n = 490)在PSP评分上有更大的改善(最小二乘平均差为3.20;95%置信区间为1.82-4.58;p < 0.0001;Cohen d = 0.31)和所有4个PSP域。在维持研究的第52周(主要是由于早期终止,其完成率较低),随机分配到brexpiprazole组的稳定患者中65.3%(62/95)实现了GAF功能缓解,随机分配到安慰剂组的稳定患者中47.1%(48/102)实现了GAF功能缓解,需要治疗的人数为6人(95%置信区间,4-22;p = .0076)。在开放标签研究的第52周(n = 177),接受brexpiprazole治疗的患者分别有84.2%和41.8%的PSP功能缓解和缓解。结论:尽管缺乏有效的比较物,但对这一大型数据集的分析表明,brexpiprazole治疗与精神分裂症患者的短期和长期临床相关功能改善有关。试验注册:本事后分析使用的数据来自ClinicalTrials.gov识别码:NCT01396421、NCT01393613、NCT01810380、NCT01668797、NCT01397786和NCT01810783的研究。
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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