Dataset Information

Treatment Persistence Between Long-Acting Injectable Versus Orally Administered Aripiprazole Among Patients with Schizophrenia in a Real-World Clinical Setting in Japan.

ABSTRACT: INTRODUCTION:Persistence with antipsychotic treatment is critical in managing patients with schizophrenia. To evaluate whether aripiprazole long-acting injection (aripiprazole once-monthly, AOM) can contribute to longer treatment persistence compared with daily orally administered aripiprazole (OA) in real-world clinical settings in Japan, treatment persistence in patients with schizophrenia was compared between patients treated with AOM and those with OA, using a claims database compiled by JMDC Inc., Tokyo, Japan. METHODS:Data of patients with schizophrenia who newly initiated AOM or OA treatment between May 2015 and November 2017 were analyzed. The Cox proportional hazard model was used to estimate the hazard ratio (HR) for treatment discontinuation of AOM vs. OA treatment, adjusted for age, sex, chlorpromazine-equivalent dose of antipsychotics, and the number of psychiatric hospitalizations. RESULTS:The analysis included 198 patients in the AOM group and 1240 patients in the OA group (mean age 38.4?±?11.9 years and 39.3?±?12.4 years, respectively). The AOM group was significantly less likely to discontinue treatment than the OA group (adjusted HR 0.54, 95% confidence interval [CI] 0.43-0.68). When using the tolerable patients extracted from the OA group (i.e., patients with at least two OA prescriptions; n?=?983) vs. the whole AOM group, AOM users were again significantly less likely to discontinue treatment (adjusted HR 0.67, 95% CI 0.53-0.86). CONCLUSION:AOM was associated with longer treatment persistence than OA in the antipsychotic treatment of patients with schizophrenia in real-world clinical settings in Japan, suggesting that the use of AOM may contribute to longer antipsychotic treatment.

SUBMITTER: Iwata N

PROVIDER: S-EPMC7314731 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Treatment Persistence Between Long-Acting Injectable Versus Orally Administered Aripiprazole Among Patients with Schizophrenia in a Real-World Clinical Setting in Japan.

Iwata Nakao N Inagaki Ataru A Sano Hiromi H Niidome Kazunari K Kojima Yoshitsugu Y Yamada Sakiko S

Advances in therapy 20200604 7

<h4>Introduction</h4>Persistence with antipsychotic treatment is critical in managing patients with schizophrenia. To evaluate whether aripiprazole long-acting injection (aripiprazole once-monthly, AOM) can contribute to longer treatment persistence compared with daily orally administered aripiprazole (OA) in real-world clinical settings in Japan, treatment persistence in patients with schizophrenia was compared between patients treated with AOM and those with OA, using a claims database compile ...[more]

PMID: 32500455

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Project description:BackgroundContinuous antipsychotic therapy is recommended as part of long-term maintenance treatment of schizophrenia, and gaps in antipsychotic treatment have been associated with increased risks of relapse and rehospitalization. Because the use of long-acting injectable (LAI) antipsychotics may reduce the likelihood of undetected medication gaps, initiating an LAI medication may affect resource utilization and costs. The LAI aripiprazole lauroxil (AL) was approved in the United States (US) in 2015 for the treatment of schizophrenia in adults.ObjectiveThe objective of this retrospective observational cohort study was to examine treatment patterns, resource utilization, and costs following initiation of AL for the treatment of schizophrenia in adults.MethodsA retrospective analysis of Medicaid claims data identified a cohort of patients (N = 485) starting AL shortly after Food and Drug Administration approval in October 2015. Treatment patterns, resource utilization, and costs were compared 6 months before and after treatment initiation. Subgroup analyses were conducted based on the type of antipsychotic (LAI, oral, or none) received before initiation of AL.ResultsOver 6 months of follow-up, patients received an average of 4.6 injections out of a maximum of six (77%). After initiating AL, all-cause inpatient admissions decreased by 22.4%; other significant reductions were observed in mental health-related admissions and emergency room (ER) visits. All-cause inpatient costs decreased by an average of US$2836 per patient (p < 0.05) in the 6-month post-AL period, whereas outpatient pharmacy costs increased by US$4121 (p < 0.05), resulting in no significant difference in overall costs between the pre- and post-AL periods. The subgroup of patients who had been prescribed an oral antipsychotic before starting AL had significant reductions in proportion of patients with inpatient and ER visits and costs, but also reported a significant increase in pharmacy costs.ConclusionsAL was associated with a significant reduction in inpatient costs and an increase in outpatient pharmacy costs, resulting in no changes in total healthcare costs over 6 months. The adherence rate and reductions in inpatient use may indicate the potential for greater clinical stability among patients initiated on AL compared with their previous treatment.

Project description:ObjectiveTo test the hypothesis that long-term maintenance with injectable risperidone long-acting therapy is superior to oral daily aripiprazole in stable patients with schizophrenia.DesignThis two-year, rater-blinded, open-label, multicenter study (NCT00299702) randomized subjects to injectable risperidone long-acting therapy (25-50mg, injected every 2 weeks) or oral aripiprazole (5-30mg/day), with study visits every two weeks. Subjects who met relapse criteria or discontinued study drug could remain in the study.SettingClinical trial.ParticipantsStable subjects with schizophrenia not adequately benefiting from current treatment who experienced two or more relapses in the past two years. If recently relapsed, subjects were stabilized (per clinician judgment) for two or more months before entry.MeasurementsPrimary endpoints: time to relapse and time in remission. Safety assessments included adverse event reporting.ResultsOf 355 subjects randomized, 349 were in the intent-to-treat analysis set. Data inspection revealed that 53 (14.9%) randomized subjects deviated from inclusion/exclusion criteria, most commonly not meeting stability requirements. At baseline, mean (standard deviation [SD]) Positive and Negative Syndrome Scale total score was 68.9 (14.6); 115 (33.0%) intent-to-treat subjects met remission criteria. Approximately 29 percent in each group discontinued the study before completing two years. No significant between-group differences were noted in time to relapse or time in remission. No new tolerability issues were identified.ConclusionRESULTS failed to demonstrate superiority with injectable risperidone long-acting therapy versus oral aripiprazole. The study design did not allow for valid conclusions of equivalence or noninferiority. Although this study attempted to mimic a real-world treatment setting for stable patients, the broad study population, the lack of patient selection for nonadherence, biweekly visits, regular assessments, and other design issues limited generalizability and interpretation relative to the study hypothesis.

Dataset Information

Treatment Persistence Between Long-Acting Injectable Versus Orally Administered Aripiprazole Among Patients with Schizophrenia in a Real-World Clinical Setting in Japan.

Publications

Treatment Persistence Between Long-Acting Injectable Versus Orally Administered Aripiprazole Among Patients with Schizophrenia in a Real-World Clinical Setting in Japan.

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