布雷哌唑治疗精神分裂症和作为重度抑郁症的辅助药物:对这种新批准的抗精神病药的疗效和安全性的系统回顾——需要治疗的数量是多少，需要伤害的数量是多少，帮助或伤害的可能性是多少?

文章的细节

引用 复制到剪贴板

Citrome L

中国临床实用杂志，2015 9月;69(9):978-97。doi: 10.1111 / ijcp.12714。Epub 2015年8月6日

PubMed ID

26250067 (PubMed视图

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摘要

目的:描述布雷哌唑治疗精神分裂症及辅助治疗重度抑郁症(MDD)的疗效、耐受性和安全性。数据来源:关键注册试验通过查询http://www.ncbi.nlm.nih.gov/pubmed/和http://www.clinicaltrials.gov，搜索关键词“brexpiprazole”或“OPC-34712”，查询EMBASE (Elsevier)商业数据库，获取临床海报摘要，并向制必威国际app造商要求在大会上展示的海报副本。产品标签提供了额外的信息。研究选择:确定了所有可用的临床研究报告。数据提取:从现有的研究报告和其他信息来源中提取主要结果的描述以及相关二分结果的治疗所需数量(NNT)和伤害所需数量(NNH)的计算。数据综合:Brexpiprazole是一种新的多巴胺D2受体部分激动剂，基于临床试验开发计划，已获批用于治疗精神分裂症和辅助治疗MDD，该临床试验开发计划包括两项关键的Brexpiprazole单药治疗急性精神分裂症的III期试验，以及两项关键的Brexpiprazole辅助治疗对标准抗抑郁治疗反应不充分的急性MDD患者的III期试验。此外，一项针对精神分裂症患者的52周复发预防/维持随机安慰剂对照戒断研究的结果是可用的。在这些试验中，布雷哌唑每天给药一次，并滴定至目标剂量。治疗精神分裂症的推荐剂量为2-4毫克/天，重度抑郁症的推荐剂量为2毫克/天。综合上述研究中关于布雷哌唑治疗急性精神分裂症的推荐目标剂量的所有可用数据，反应率为45.5%，安慰剂为31.0%，NNT为7 (95% CI 5-12)。 In the relapse prevention/maintenance trial, significantly fewer patients relapsed in the brexpiprazole group compared with placebo (13.5% vs. 38.5%), resulting in a NNT of 4 (95% CI 3-8). When the results for brexpiprazole 1, 2 and 3 mg from the two Phase III MDD trials are pooled together, 23.2% of the patients receiving brexpiprazole were responders, vs. 14.5% for placebo, yielding a NNT of 12 (95% CI 8-26). Brexpiprazole was well tolerated - for schizophrenia, discontinuation rates because of an adverse event (AE) were overall lower for patients receiving brexpiprazole vs. placebo, and for MDD a total of 3% of brexpiprazole-treated patients and 1% of placebo-treated patients discontinued because of AEs, resulting in a NNH of 53 (95% CI 30-235). Although the most commonly encountered AE noted in product labelling was akathisia (5.5% in the acute schizophrenia trials and 8.6% in the MDD trials), differences from placebo were small, generating a non-significant NNH of 112 for patients with schizophrenia and a modest NNH of 15 (95% CI 11-23) for patients with MDD. Short-term weight gain appears modest; however, more outliers with an increase of >/= 7% of body weight were evident in open-label 52-week safety studies. Effects on glucose and lipids were small. Minimal effects on prolactin were observed, and no clinically relevant effects on the ECG QT interval were evident. CONCLUSIONS: Clinical trials of brexpiprazole support its efficacy at the recommended target dose of 2-4 mg/day for the treatment of schizophrenia, and at the recommended target dose of 2 mg/day as adjunct to antidepressant medication for the treatment of MDD. Head-to-head comparisons with other available agents among patients with schizophrenia and MDD in the 'real world' are needed.

引用本文的药物库数据

药物: Brexpiprazole