Kane John M, Zhao Cathy, Johnson Brian R, Baker Ross A, Eramo Anna, McQuade Robert D, Duca Anna R, Sanchez Raymond, Peters-Strickland Timothy
The Zucker Hillside Hospital, Glen Oaks, and the Hofstra North Shore-LIJ School of Medicine , Hempstead, NY , USA.
J Med Econ. 2015 Feb;18(2):145-54. doi: 10.3111/13696998.2014.979936. Epub 2014 Nov 10.
To compare hospitalization rates in patients with schizophrenia treated prospectively with aripiprazole once-monthly 400 mg (AOM 400; an extended-release injectable suspension) vs the same patients' retrospective rates with their prior oral anti-psychotic therapy.
Multi-center, open-label, mirror-image, naturalistic study in a community setting in North America. Patients who required a change in treatment and/or would benefit from long-acting injectable anti-psychotic therapy were treated prospectively for 6 months with AOM 400. Retrospective data on hospitalization rates were obtained.
ClinicalTrials.gov: NCT01432444.
The proportion of patients with ≥ 1 psychiatric inpatient hospitalization with oral anti-psychotic therapy examined retrospectively (months -4 to -1 before oral conversion) and after switching to AOM 400 (months 4-6 after initiating AOM 400).
Psychiatric hospitalization rates were significantly lower when patients were treated with AOM 400 compared with oral anti-psychotic therapy both in the 3-month primary efficacy sample (2.7% [n = 9/336] vs 27.1% [n = 91/336], respectively; p < 0.0001) and in the total sample (6-month prospective rate: 8.8% [n = 38/433] vs 6-month retrospective rate: 38.1% [n = 165/433]; p < 0.0001). Discontinuations due to adverse events (AEs) during cross-titration were lower in patients cross-titrated on oral aripiprazole for >1 and <4 weeks (2.9% [n = 7/239]) compared with patients cross-titrated for ≤ 1 week (10.4% [n = 5/48]). The most common treatment-emergent AEs during the prospective treatment phase were insomnia (6.7% [n = 29/431]) and akathisia (6.5% [n = 28/431]). Patient-rated injection-site pain decreased from the first injection to the last visit.
In a community setting, patients with schizophrenia demonstrated significantly lower psychiatric hospitalization rates after switching from their prior oral anti-psychotic therapy to AOM 400. Patients served as their own control, and thus an active control group was not included in this study. Confounding factors, such as insurance coverage and availability of hospital beds, were not examined here and deserve further consideration.
比较接受每月一次400mg阿立哌唑（AOM 400；一种缓释注射用混悬液）前瞻性治疗的精神分裂症患者的住院率与这些患者先前口服抗精神病药物治疗时的回顾性住院率。
在北美的社区环境中进行的多中心、开放标签、镜像、自然主义研究。需要改变治疗和/或将从长效注射用抗精神病药物治疗中获益的患者接受AOM 400前瞻性治疗6个月。获取关于住院率的回顾性数据。
ClinicalTrials.gov：NCT01432444。
回顾性检查口服抗精神病药物治疗期间（口服转换前-4至-1个月）以及转换为AOM 400后（开始AOM 400治疗后4至6个月）≥1次精神科住院治疗的患者比例。
在3个月的主要疗效样本中（分别为2.7%[n = 9/336]对27.1%[n = 91/336]；p < 0.0001）以及在总样本中（6个月前瞻性发生率：8.8%[n = 38/433]对6个月回顾性发生率：38.1%[n = 165/433]；p < 0.0001），与口服抗精神病药物治疗相比，患者接受AOM 400治疗时的精神科住院率显著更低。在口服阿立哌唑交叉滴定>1周且<4周的患者中，因不良事件（AE）导致的停药率（2.9%[n = 7/239]）低于交叉滴定≤1周的患者（10.4%[n = 5/48]）。前瞻性治疗阶段最常见的治疗中出现的AE为失眠（6.7%[n = 29/431]）和静坐不能（6.5%[n = 28/431]）。患者报告的注射部位疼痛从首次注射到最后一次就诊时有所减轻。
在社区环境中，精神分裂症患者从先前的口服抗精神病药物治疗转换为AOM 400治疗后，精神科住院率显著降低。患者自身作为对照，因此本研究未纳入活性对照组。诸如保险覆盖范围和医院床位可用性等混杂因素在此未进行检查，值得进一步考虑。
