Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.
H. Lundbeck A/S, Valby, Copenhagen, Denmark.
J Psychopharmacol. 2020 Aug;34(8):829-838. doi: 10.1177/0269881120936485. Epub 2020 Jul 10.
The treatment of patients with severe schizophrenia symptoms can be complicated and expensive.
The purpose of this study was to evaluate the short- and long-term effects of brexpiprazole in patients with schizophrenia presenting with severe symptoms.
Data were pooled from three six-week, randomized, double-blind, placebo-controlled studies and two 52-week, open-label extension studies. In the short-term studies, 1405 patients received placebo or brexpiprazole 2-4 mg/day; 412 brexpiprazole-treated patients rolled over into the long-term studies and received brexpiprazole 1-4 mg/day. More severe symptoms were defined as a Positive and Negative Syndrome Scale Total score >95 (median score at baseline). Outcomes included change in Positive and Negative Syndrome Scale Total and Personal and Social Performance scale scores.
Brexpiprazole improved Positive and Negative Syndrome Scale Total score over 6 weeks among more severely ill patients, with a least squares mean difference versus placebo of -6.76 (95% confidence limits: -9.80, -3.72; <0.0001; Cohen's : 0.43). Brexpiprazole also improved Personal and Social Performance scale score over 6 weeks in more severely ill patients (least squares mean difference: 4.38; limits: 2.14, 6.62; =0.0001; Cohen's : 0.38). Improvement of functioning was greatest in the 'Self-care' domain, followed by 'Personal and social relationships'. Among less severely ill patients, brexpiprazole was superior to placebo on Positive and Negative Syndrome Scale Total and Personal and Social Performance scale at Week 6. Improvements were maintained over 58 weeks. No new safety or tolerability concerns were observed.
Brexpiprazole is an efficacious and well-tolerated treatment for schizophrenia in patients with more severe, and less severe, symptoms.
治疗伴有严重症状的重度精神分裂症患者可能较为复杂且费用较高。
本研究旨在评估布瑞哌唑治疗伴有严重症状的精神分裂症患者的短期和长期疗效。
本研究数据来自三项为期 6 周的随机、双盲、安慰剂对照研究和两项为期 52 周的开放标签扩展研究。在短期研究中，1405 例患者接受安慰剂或布瑞哌唑 2-4mg/天治疗；412 例布瑞哌唑治疗患者进入长期研究并接受布瑞哌唑 1-4mg/天治疗。更严重的症状定义为阳性和阴性症状量表总分＞95 分（基线时的中位数评分）。主要结局指标包括阳性和阴性症状量表总分和个人和社会表现量表评分的变化。
在更严重的患者中，布瑞哌唑治疗 6 周后可改善阳性和阴性症状量表总分，与安慰剂相比，其最小二乘均数差值为-6.76（95%置信区间：-9.80，-3.72；＜0.0001；Cohen's d：0.43）。在更严重的患者中，布瑞哌唑还可改善个人和社会表现量表评分（最小二乘均数差值：4.38；范围：2.14，6.62；=0.0001；Cohen's d：0.38）。在更严重的患者中，“自我护理”领域的功能改善最大，其次是“个人和社会关系”。在症状较轻的患者中，布瑞哌唑在第 6 周时在阳性和阴性症状量表总分和个人和社会表现量表上优于安慰剂。这些改善在 58 周内得以维持。未观察到新的安全性或耐受性问题。
布瑞哌唑治疗伴有严重和较轻症状的精神分裂症患者安全有效。
