Jones Meghan E, Andrews Jeffrey S, Faries Douglas E, Landry John, Xu Jenny, Detke Holland C, Chhabra-Khanna Rashna, McDonnell David P
Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Eli Lilly Canada, Inc., Toronto, ON, M1N 2E8, Canada.
BMC Psychiatry. 2015 Nov 13;15:278. doi: 10.1186/s12888-015-0669-5.
Depot antipsychotics are a treatment option for medication nonadherence in patients with schizophrenia. Nonadherence can lead to increased relapse and hospitalization rates. This article reports hospitalization data before and after initiation of olanzapine long-acting injection (LAI), a depot antipsychotic.
Data were assessed from an ongoing, multinational, prospective, observational post-authorisation safety study being conducted to evaluate post-injection delirium/sedation syndrome (PDSS), an adverse reaction that can occur following injection of olanzapine LAI. Eligible patients were aged ≥18 years, diagnosed with schizophrenia, were prescribed olanzapine LAI, and lived outside the United States. Psychiatric hospitalization and medication data were collected retrospectively for the 6-month period before study entry and prospectively throughout the study. Paired t-tests and McNemar's tests were used to assess changes in hospitalization incidence and duration. Stepwise Cox proportional hazards models assessed factors associated with hospitalizations. Analyses were based on data from the first 3 years of the continuously enrolling study (N = 668).
The average duration of olanzapine LAI exposure for all patients was 0.768 years. Of the 529 patients who received at least 1 injection of olanzapine LAI and were not hospitalized at study entry, 8.1% had at least 1 subsequent psychiatric hospitalization with a mean duration of 2.0 days. Of the 288 patients who had a >6-month follow-up, 8.3% had at least 1 post-baseline psychiatric hospitalization with a mean duration of 2.3 days. The incidence of hospitalizations in the 6-month period after treatment was significantly lower than that in the 6-month period prior to treatment (8.3 vs 32.6%, respectively; P < 0.001). Furthermore, mean hospitalization duration decreased from 11.5 days in the 6-month period before treatment to 2.3 days in the 6-month period after treatment (P < 0.001). Psychiatric hospitalization in the prior 12 months (P < 0.0001) and recreational drug use within 24 h of baseline visit (P = 0.015) were identified as potential predictors of time to first psychiatric hospitalization after beginning to take olanzapine LAI. At the time of interim analysis, 5 PDSS events had occurred, which was too few for a full analysis of those events.
Results indicate a significant reduction in the incidence and days of hospitalization from the 6-month period before to the 6-month period after olanzapine LAI initiation, which suggests reduced relapse and hospitalization during treatment. Results should be interpreted with caution due to the observational nature of the study and use of retrospective baseline data.
长效抗精神病药物是治疗精神分裂症患者药物不依从性的一种选择。药物不依从会导致复发率和住院率增加。本文报告了长效抗精神病药物奥氮平长效注射剂（LAI）起始治疗前后的住院数据。
数据来自一项正在进行的多国、前瞻性、观察性上市后安全性研究，该研究旨在评估注射后谵妄/镇静综合征（PDSS），这是一种注射奥氮平LAI后可能发生的不良反应。符合条件的患者年龄≥18岁，诊断为精神分裂症，开具了奥氮平LAI处方，且居住在美国境外。回顾性收集研究入组前6个月的精神科住院和用药数据，并在整个研究过程中前瞻性收集。采用配对t检验和McNemar检验评估住院发生率和住院时间的变化。逐步Cox比例风险模型评估与住院相关的因素。分析基于连续入组研究前3年的数据（N = 668）。
所有患者奥氮平LAI的平均暴露时间为0.768年。在529例接受至少1次奥氮平LAI注射且在研究入组时未住院的患者中，8.1%随后至少有1次精神科住院，平均住院时间为2.0天。在288例随访时间>6个月的患者中，8.3%在基线后至少有1次精神科住院，平均住院时间为2.3天。治疗后6个月期间的住院发生率显著低于治疗前6个月期间（分别为8.3%和32.6%；P < 0.001）。此外，平均住院时间从治疗前6个月的11.5天降至治疗后6个月的2.3天（P < 0.001）。既往12个月内的精神科住院（P < 0.0001）和基线访视后24小时内使用消遣性药物（P = 0.015）被确定为开始服用奥氮平LAI后首次精神科住院时间的潜在预测因素。在中期分析时，发生了5例PDSS事件，数量太少无法对这些事件进行全面分析。
结果表明，从奥氮平LAI起始治疗前6个月到治疗后6个月，住院发生率和住院天数显著降低，这表明治疗期间复发率和住院率降低。由于研究的观察性性质以及回顾性基线数据的使用，结果应谨慎解释。
