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

Abstract

IntroductionFew 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.MethodsTwo 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.ResultsFinal 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).ConclusionsIn 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.FundingOtsuka Pharmaceutical Development and Commercialization, Inc. and Lundbeck.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0785-y) contains supplementary material, which is available to authorized users.

Discontinuation rates during long‐term, second‐generation antipsychotic long‐acting injection treatment: A systematic review

“…This failed quest could be due to several reasons, the principal one being the equivocal and inconsistent results obtained from different studies . However, results presented here demonstrate relatively high and equivalent discontinuation rates in studies on SGA‐LAI conducted in patients with SCZ and those with BD …”

“…Two separate retrospective cohort analyses were conducted to compare medication adherence and discontinuation in patients with SCZ or BD‐I who started ARI‐LAI 400 mg treatment versus patients changed from one oral antipsychotic monotherapy to another. In both populations of ARI‐treated patients, the rate of premature discontinuation was higher than 60% …”

“…High discontinuation rates were also found in studies terminated early because of the positive interim analysis performed by the sponsor . The main reasons leading to premature discontinuation were withdrawal of consent and the onset of adverse events …”

“…Another seven articlesfour regarding PP and three RIS-LAI -provided further relevant details about the original research and, for this reason, were included in the tabular data, as they contributed to the overall results and thus the conclusions. (Table 1 [31][32][33][34][35] ) ARI depot is a lyophilized powder of ARI. 36 In a randomized, PLAcontrolled study involving patients diagnosed with SCZ spectrum disorders, the overall discontinuation rate (mainly due to the onset of adverse events) was two-fold higher in the PLA-group compared with that recorded in the ARI-LAI group.…”

“…In both populations of ARI-treated patients, the rate of premature discontinuation was higher than 60%. 35 ARI-LXL is a new formulation of ARI-LAI, available in the range of dosages between 441 and 882 mg. At time of writing, no long-term studies on ARI-LXL have been published. 19,37 OLA-LAI (Table 2 [38][39][40] ) OLA-LAI is the pamoate salt of OLA.…”