Brexpiprazole为精神分裂症和重度抑郁症的兼职:系统回顾这个新批准的疗效和安全性的抗精神病药物,治疗所需的数量,数量需要伤害和可能性是帮助还是伤害?

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Citrome L

Int中国Pract。2015年9月,69 (9):978 - 97。doi: 10.1111 / ijcp.12714。Epub 2015年8月6日。

PubMed ID

26250067 (在PubMed

]

文摘

目的:描述疗效、耐受性和安全性brexpiprazole治疗精神分裂症和重度抑郁症(MDD)的兼职。数据来源:关键登记试验是通过查询访问http://www.ncbi.nlm.nih.gov/pubmed/和http://www.clinicaltrials.gov,为搜索条件“brexpiprazole”或“opc - 34712”,也通过查询EMBASE(爱思唯尔)临床海报摘要商业数据库,并要求制造商海报在大会的副本。产品标签提供额外的信息。研究选择:所有可用的临床研究发现的报告。数据提取:主要结果的描述和计算所需的数量来治疗(例数十分)和数量需要伤害(NNH)相关二分结果提取可用的研究报告和其他的信息来源。数据合成:Brexpiprazole是一个新的多巴胺D2受体部分激动剂获得批准用于治疗精神分裂症和用于辅助治疗MDD的基于临床试验的发展计划,包括两个关键的第三阶段试验Brexpiprazole单一疗法在急性精神分裂症,和两个关键的第三阶段试验辅助Brexpiprazole患者在急性MDD证明标准抗抑郁治疗反应不足。此外,结果从52周复发预防/维护随机安慰剂对照研究精神分裂症患者可用撤军。在这些试验中,brexpiprazole每日服用一次,目标剂量滴定。治疗精神分裂症的推荐剂量是2 - 4毫克/天,MDD, 2毫克/天。收集到的所有可用的数据建议目标剂量的brexpiprazole急性精神分裂症从上面的研究,为安慰剂反应者的比例是45.5%比31.0%,收益率例数十分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.

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药物: Brexpiprazole