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首页> 外文期刊>The international journal of neuropsychopharmacology >A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Maintenance Treatment in Adults with Schizophrenia
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A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Maintenance Treatment in Adults with Schizophrenia

机译：一项长期，开放标签的研究，评估布雷普拉唑作为成人精神分裂症维持治疗的安全性和耐受性

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Background Brexpiprazole is a serotonin–dopamine activity modulator with efficacy in acute schizophrenia and relapse prevention. The aim of this Phase 3, multicenter study was to assess the long-term safety, tolerability, and efficacy of treatment with brexpiprazole flexible-dose 1–4 mg/d. Methods Patients rolled over into this 52-week open-label study (amended to 26 weeks towards the end) from 3 randomized, double-blind, placebo-controlled Phase 3 studies. De novo patients, not part of the previous studies, were also enrolled. The primary outcome variable was the frequency and severity of treatment-emergent adverse events. Efficacy was assessed as a secondary objective using the Positive and Negative Syndrome Scale and the Personal and Social Performance scale. Results A total of 1072 patients was enrolled (952 for 52 weeks and 120 for 26 weeks), 47.4% of whom completed the study. Among patients who took at least one dose of brexpiprazole, 14.6% discontinued due to treatment-emergent adverse events, most commonly schizophrenia (8.8%) and psychotic disorder (1.5%). Treatment-emergent adverse events with an incidence of ≥5% were schizophrenia (11.6%), insomnia (8.6%), weight increased (7.8%), headache (6.4%), and agitation (5.4%). Most treatment-emergent adverse events were mild or moderate in severity. The mean increase in body weight from baseline to week 26 was 1.3 kg and to week 52 was 2.1 kg. There were no clinically relevant findings related to prolactin, lipids, and glucose, or QT prolongation. On average, patients’ symptoms and functioning showed continual improvement. Conclusions Treatment with brexpiprazole 1–4 mg/d was generally well tolerated for up to 52 weeks in patients with schizophrenia. ClinicalTrials.gov identifier NCT01397786 ( https://clinicaltrials.gov/show/NCT01397786 ). brexpiprazole , long-term , open-label , schizophrenia Significance Statement Brexpiprazole is an antipsychotic that has shown a clinically meaningful benefit for the acute treatment of schizophrenia in 2 placebo-controlled clinical studies. A further, long-term study showed that brexpiprazole maintenance therapy reduced the risk of relapse vs placebo over the course of a year. The study described in this paper is an extension of these 3 studies, which was designed primarily to assess the long-term safety and tolerability of brexpiprazole treatment. The study also enrolled patients who had not previously been in a brexpiprazole study. For up to 1 year, patients received open-label brexpiprazole that was flexibly dosed in the range of 1–4 mg/d. No unexpected safety or tolerability issues emerged, and the safety profile was consistent with the previous brexpiprazole studies in schizophrenia. Overall, this study adds to the evidence-base demonstrating that brexpiprazole is a generally well-tolerated antipsychotic in the long-term.
机译：背景布雷哌拉唑是一种5-羟色胺-多巴胺活性调节剂，在急性精神分裂症和复发预防中具有疗效。这项3期多中心研究的目的是评估brexpiprazole柔性剂量1-4 mg / d的长期安全性，耐受性和疗效。方法患者从3项随机，双盲，安慰剂对照的3期研究进入了这项为期52周的开放标签研究（至末期修正为26周）。新入组的患者（不是先前研究的一部分）也入选了。主要结局变量是突发性治疗不良事件的发生频率和严重程度。使用阳性和阴性综合征量表以及个人和社会绩效量表将疗效评估为次要目标。结果共纳入1072例患者（952例为52周，120例为26周），其中47.4％完成了研究。在至少服用一剂brexpiprazole的患者中，有14.6％的患者因出现治疗不良反应而中断治疗，最常见的是精神分裂症（8.8％）和精神病（1.5％）。发生率≥5％的治疗紧急不良事件为精神分裂症（11.6％），失眠（8.6％），体重增加（7.8％），头痛（6.4％）和躁动（5.4％）。大多数出现治疗的不良事件是轻度或中度。从基线到第26周的平均体重增加为1.3千克，到第52周的平均体重为2.1千克。没有与催乳素，脂质和葡萄糖或QT延长相关的临床相关发现。平均而言，患者的症状和功能显示出持续改善。结论精神分裂症患者一般可耐受brexpiprazole 1-4 mg / d的治疗，长达52周。 ClinicalTrials.gov标识符NCT01397786（https://clinicaltrials.gov/show/NCT01397786）。 brexpiprazole，长期的，开放标签的，精神分裂症的重要意义声明Brexpiprazole是一种抗精神病药，在两项安慰剂对照的临床研究中显示出对急性精神分裂症的急性治疗具有临床意义。进一步的长期研究表明，与安慰剂相比，brexpiprazole维持治疗可在一年的时间内降低复发风险。本文描述的研究是这3项研究的扩展，这些研究的主要目的是评估brexpiprazole治疗的长期安全性和耐受性。该研究还招募了以前没有参加过brexpiprazole研究的患者。在长达1年的时间里，患者接受了开放标签的brexpiprazole，其剂量范围为1-4 mg / d。没有出现意料之外的安全性或耐受性问题，并且安全性与先前在精神分裂症中的brexpiprazole研究一致。总的来说，这项研究增加了证据基础，表明从长远来看，brexpiprazole通常是耐受良好的抗精神病药。

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