Global Clinical Development (CNS), Otsuka Pharmaceutical Development & Commercialization, Inc. , Princeton, NJ, USA.
CNS Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc. , Princeton, NJ, USA.
NPJ Schizophr. 2015 Nov 4;1:15039. doi: 10.1038/npjschz.2015.39. eCollection 2015.
Long-term maintenance treatment with an antipsychotic is often required to prevent relapse and mitigate functional deterioration in patients with schizophrenia.
This study assessed the long-term safety, tolerability, and maintenance of the therapeutic effect of aripiprazole once-monthly 400 mg (AOM 400) in patients with schizophrenia.
This 52-week, open-label study included patients previously enrolled in 1 of 2 AOM 400 randomized controlled trials (RCTs) and de novo patients. Safety endpoints included adverse events (AEs), suicidality, extrapyramidal symptoms, injection-site pain, and clinically relevant changes in clinical and laboratory values. The primary efficacy endpoint was the percentage of stable patients at baseline who remained stable at the last visit of the AOM 400 maintenance phase. All endpoints were assessed with descriptive statistics; there were no formal planned statistical analyses.
Of 1,247 patients screened, 1,178 enrolled in the study (194 de novo and 984 patients from the RCTs) and 1,081 received maintenance treatment with AOM 400. The maintenance phase completion rate was 79.4% at 52 weeks. Treatment-emergent AEs in ⩾5% of patients during open-label AOM 400 treatment were headache (7.6%), nasopharyngitis (7.0%), anxiety (6.8%), and insomnia (6.6%). There were no clinically relevant changes in safety parameters of interest. Ninety-five percent of stable patients at baseline remained stable at their last visit during the AOM 400 maintenance phase.
The long-term safety and tolerability profile of AOM 400 was comparable to the RCTs, and the long-term therapeutic effect was maintained.
长期使用抗精神病药物维持治疗，通常可预防精神分裂症患者复发和功能恶化。
本研究评估了阿立哌唑每月 400mg 长效针剂（AOM 400）在精神分裂症患者中的长期安全性、耐受性和疗效维持情况。
这是一项为期 52 周、开放性标签的研究，纳入了先前参加过两项 AOM 400 随机对照试验（RCT）之一的患者和新诊断患者。安全性终点包括不良事件（AE）、自杀意念、锥体外系症状、注射部位疼痛以及临床相关的实验室值变化。主要疗效终点是基线时稳定的患者中，在 AOM 400 维持阶段最后一次就诊时仍保持稳定的比例。所有终点均采用描述性统计方法进行评估；未进行正式的计划统计分析。
在 1247 名筛选患者中，1178 名入组研究（194 名新诊断患者和 984 名来自 RCT 的患者），1081 名患者接受 AOM 400 的维持治疗。在 52 周时，维持阶段的完成率为 79.4%。在开放性 AOM 400 治疗期间，发生率 ⩾5%的治疗期间出现的 AE 为头痛（7.6%）、鼻咽炎（7.0%）、焦虑（6.8%）和失眠（6.6%）。无安全性参数发生有临床意义的变化。在 AOM 400 维持阶段的最后一次就诊时，95%的基线时稳定的患者保持稳定。
AOM 400 的长期安全性和耐受性与 RCT 相似，长期疗效得到维持。
