Treatment Effect With Paliperidone Palmitate Compared With Oral Antipsychotics in Black/African American Patients With Schizophrenia and a History of Criminal Justice System Involvement: A Post Hoc Analysis of the PRIDE Study.

Autor:	Bell Lynum KS; Janssen Scientific Affairs, LLC, Titusville, New Jersey.; Corresponding author: Karimah S. Bell Lynum, PharmD, MBA, BCPP, Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560 (klynum@ITS.JNJ.com)., Henderson DC; Department of Psychiatry, Boston University School of Medicine and Boston Medical Center, Boston, Massachusetts., Wright HJ; Department of Psychology, Temple University, Philadelphia, Pennsylvania., Gogate JP; Janssen Research and Development, LLC, Titusville, New Jersey., Kim E; Janssen Scientific Affairs, LLC, Titusville, New Jersey.; Affiliation at the time the analysis was conducted.
Jazyk:	angličtina
Zdroj:	The Journal of clinical psychiatry [J Clin Psychiatry] 2021 Feb 23; Vol. 82 (2). Date of Electronic Publication: 2021 Feb 23.
DOI:	10.4088/JCP.20m13356
Abstrakt:	Objective: To examine the efficacy and safety of paliperidone palmitate once-monthly (PP1M) versus oral antipsychotics (OAPs) in Black/African American patients with schizophrenia and a history of criminal justice system involvement. Methods: This was a post hoc analysis of a 15-month prospective, randomized, open-label, parallel-group, multicenter US study conducted from May 2010 to December 2013 that examined a subpopulation of Black/African American patients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria). The primary objective was to compare time to first treatment failure in patients treated with PP1M versus OAPs. Secondary objectives were to compare time to first institutionalization (psychiatric hospitalization or arrest/incarceration) and mean number of treatment failure events and institutionalizations over 15 months in PP1M-treated and OAP-treated patients. Results: The intention-to-treat population included 275 Black/African American patients (PP1M, n = 145; OAPs, n = 130). Median time to first treatment failure was not reached for PP1M-treated patients and was 270 days for OAP-treated patients; hazard ratio (HR) was 1.39 (95% CI, 0.97-1.99; P = .075). Median time to first institutionalization was not reached for PP1M-treated patients and was 304 days for OAP-treated patients; HR was 1.49 (95% CI, 1.01-2.19; P = .043). Mean numbers of treatment failure events and institutionalizations were lower with PP1M than OAPs. The safety profile of PP1M was consistent with that of previous PP1M studies. Conclusions: In a Black/African American subpopulation of patients with schizophrenia and prior criminal justice system involvement, PP1M reduced the number of treatment failures, thereby reducing the number of psychiatric hospitalizations and/or arrests/incarcerations compared with daily OAPs. Trial Registration: ClinicalTrials.gov identifier: NCT01157351. (© Copyright 2021 Physicians Postgraduate Press, Inc.)
Databáze:	MEDLINE
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