精神分裂症或双相情感障碍患者使用阿立哌唑一月一次 400mg（AOM 400）与口服抗精神病药物相比的药物依从性和停药情况：一项使用美国索赔数据的真实世界研究。
Medication Adherence and Discontinuation of Aripiprazole Once-Monthly 400 mg (AOM 400) Versus Oral Antipsychotics in Patients with Schizophrenia or Bipolar I Disorder: A Real-World Study Using US Claims Data.
机构信息
Partnership for Health Analytic Research, LLC, Beverly Hills, CA, USA.
Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
出版信息
Adv Ther. 2018 Oct;35(10):1612-1625. doi: 10.1007/s12325-018-0785-y. Epub 2018 Sep 11.
INTRODUCTION
Few studies have compared adherence between long-acting injectable antipsychotics, especially for newer agents like aripiprazole once-monthly 400 mg (AOM 400; aripiprazole monohydrate) and oral antipsychotics, in patients with schizophrenia or bipolar I disorder (BD-I) in a real-world setting.
METHODS
Two separate retrospective cohort analyses using Truven MarketScan data from January 1, 2012 to June 30, 2016 were conducted to compare medication adherence and discontinuation in patients with schizophrenia or BD-I who initiated treatment with AOM 400 vs. patients changed from one oral antipsychotic monotherapy to another. Adherence was defined as proportion of days covered (PDC) ≥ 0.80 in the year following the index date. Linear regression models examined the association between AOM 400 and oral antipsychotic cohorts and medication adherence. Kaplan-Meier curves and Cox regression estimated time to and risk of discontinuation, while adjusting for baseline covariates. A sensitivity analysis was conducted using a combination of propensity score matching and exact matching to create matched cohorts.
RESULTS
Final cohort sizes were as follows-Schizophrenia: AOM 400 n = 408, oral antipsychotic n = 3361; BD-I: AOM 400 n = 413, oral antipsychotic n = 15,534. In patients with schizophrenia, adjusted mean PDC was higher in patients in the AOM 400 cohort vs. the oral antipsychotic cohort (0.57 vs. 0.48 P < 0.001), and patients in the oral antipsychotic cohort had a higher risk of discontinuing treatment vs. the AOM 400 cohort (HR 1.45, 95% CI 1.29-1.64). For patients with BD-I, adjusted mean PDC was higher for the AOM 400 cohort (0.59 vs. 0.44, P < 0.001), and patients in the oral antipsychotic cohort had a higher risk of discontinuation (HR 1.71, 95% CI 1.53-1.92).
CONCLUSIONS
In a real-word setting, AOM 400 resulted in a significantly higher percentage of patients with a PDC ≥ 0.80 and significantly longer time to treatment discontinuation compared to patients with schizophrenia or BD-I who received treatment with an oral antipsychotic.
FUNDING
Otsuka Pharmaceutical Development and Commercialization, Inc. and Lundbeck.
简介
在真实世界环境中，很少有研究比较长效注射抗精神病药物之间的依从性，尤其是对于新型药物，如阿立哌唑每月 400mg 长效针剂（AOM 400；阿立哌唑一水合物）和口服抗精神病药，在精神分裂症或双相 I 型障碍（BD-I）患者中的比较。
方法
使用 Truven MarketScan 数据进行了两项独立的回顾性队列分析，数据来自 2012 年 1 月 1 日至 2016 年 6 月 30 日，比较了起始治疗时使用 AOM 400 的精神分裂症或 BD-I 患者与从一种口服抗精神病药单药治疗转为另一种口服抗精神病药单药治疗的患者的药物依从性和停药情况。依从性定义为索引日期后一年的比例达标天数（PDC）≥0.80。线性回归模型检查了 AOM 400 与口服抗精神病药队列之间的关联与药物依从性。Kaplan-Meier 曲线和 Cox 回归估计了停药时间和停药风险，并在调整了基线协变量后进行了分析。使用倾向评分匹配和精确匹配的组合进行了敏感性分析，以创建匹配队列。
结果
最终队列规模如下：精神分裂症：AOM 400 n=408，口服抗精神病药 n=3361；BD-I：AOM 400 n=413，口服抗精神病药 n=15534。在精神分裂症患者中，与口服抗精神病药队列相比，AOM 400 队列的调整后平均 PDC 更高（0.57 对 0.48，P<0.001），且口服抗精神病药队列的停药风险更高（HR 1.45，95%CI 1.29-1.64）。对于 BD-I 患者，AOM 400 队列的调整后平均 PDC 更高（0.59 对 0.44，P<0.001），且口服抗精神病药队列的停药风险更高（HR 1.71，95%CI 1.53-1.92）。
结论
在真实世界环境中，与接受口服抗精神病药治疗的精神分裂症或 BD-I 患者相比，AOM 400 治疗可使 PDC≥0.80的患者比例显著提高，且治疗停药时间显著延长。
资金来源
大冢制药研发与商业化公司和灵北公司。
Zotero 插件