ObjectiveEvaluate safety and tolerability of an aripiprazole lauroxil (AL) 2-month regimen using 1-day initiation in patients hospitalized for acute exacerbation of schizophrenia and transitioned to outpatient care.MethodsIn the 25-week, double-blind ALPINE study, adults hospitalized for an acute exacerbation of schizophrenia were randomized to AL (AL NanoCrystal Dispersion + oral aripiprazole 30 mg day 1; AL 1064 mg day 8 and q8wk) or the active control paliperidone palmitate (PP 234 mg day 1; PP 156 mg day 8 and q4wk), discharged after 2 weeks if clinically stable, and followed through the end of the study. Adverse events, including adverse events of special interest (AESIs; extrapyramidal symptoms [identified by non-mutually exclusive standardized MedDRA queries], sedation, hypotension, injection site reactions [ISRs], suicidal ideation and behavior) were monitored throughout the study.ResultsIn total, 200 patients were randomized (AL, n=99; PP, n=101); 99 patients (AL, n= 56; PP, n=43) completed the study. Rates of AESIs in AL-treated patients were akathisia, 10%; Parkinson-like events, 2%; dyskinesia, 3%; dystonia, 9%; sedation, 7%; hypotension, 6%; ISRs, 18 % (including placebo); and suicidal ideation and behavior, 2 %. In PP-treated patients, AESI rates were akathisia, 12%; Parkinson-like events, 4%; dyskinesia, 5%; dystonia, 11%; sedation, 7%; hypotension, 4%; ISRs, 27% (including placebo); and suicidal ideation and behavior, 3%.Conclusion(s)No unexpected safety and tolerability findings were identified in patients treated with AL or PP who were hospitalized for acute schizophrenia exacerbation and transitioned to outpatient care in ALPINE. AESI profiles were consistent with each treatment’s respective known safety profile.FundingAlkermes, Inc.DisclosuresAll authors are employees of Alkermes, Inc., and may own stock/options in the company.

中文翻译：

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在 ALPINE 研究中，阿立哌唑月桂醇 2 个月制剂和 1 天开始治疗精神分裂症的安全性和耐受性

目的评估阿立哌唑月桂醇 (AL) 2 个月方案在因精神分裂症急性加重住院并转为门诊治疗的患者中的安全性和耐受性。方法在为期 25 周的双盲 ALPINE 研究中，成人住院治疗精神分裂症的急性发作被随机分配到 AL（AL NanoCrystal Dispersion + 口服阿立哌唑 30 mg 第 1 天；AL 1064 mg 第 8 天和 q8wk）或活性对照帕利哌酮棕榈酸酯（PP 234 mg 第 1 天；PP 156 mg 第 8 天和 q4wk），如果临床稳定，则在 2 周后出院，并随访至研究结束。不良事件，包括特别感兴趣的不良事件（AESIs；锥体外系症状 [通过非互斥标准化 MedDRA 查询识别]、镇静、低血压、注射部位反应 [ISR]、在整个研究过程中监测自杀意念和行为。结果总共有 200 名患者被随机分组​​（AL，n=99；PP，n=101）；99 名患者（AL，n=56；PP，n=43）完成了研究。AL 治疗患者的 AESIs 发生率为 10%；帕金森样事件，2%；运动障碍，3%；肌张力障碍，9%；镇静剂，7%；低血压，6%；ISR，18%（包括安慰剂）；和自杀意念和行为，2%。在 PP 治疗的患者中，AESI 发生率为 12%；帕金森样事件，4%；运动障碍，5%；肌张力障碍，11%；镇静剂，7%；低血压，4%；ISR，27%（包括安慰剂）；和自杀意念和行为，3%。结论 在因急性精神分裂症恶化住院并转至 ALPINE 门诊治疗的 AL 或 PP 治疗的患者中，未发现意外的安全性和耐受性发现。