Switching to paliperidone extended release in patients with schizophrenia dissatisfied with previous olanzapine treatment: Post hoc analysis of an open-label, prospective study

• Published in: Medicine (Baltimore) Vol. 98; no. 3; p. e13688
• Main Authors: Si, Tian Mei, Cai, Shang Li, Zhuo, Jian Min, Zhang, Li Li
• Format: Journal Article
• Language: English
• Published: United States Wolters Kluwer Health 01.01.2019
• Subjects: Adult; Akathisia, Drug-Induced - epidemiology; Antipsychotic Agents - administration & dosage; Antipsychotic Agents - adverse effects; Antipsychotic Agents - therapeutic use; China - epidemiology; Clinical Trial/Experimental Study; Drug Substitution - methods; Female; Humans; Male; Olanzapine - adverse effects; Paliperidone Palmitate - administration & dosage; Paliperidone Palmitate - adverse effects; Paliperidone Palmitate - therapeutic use; Patient Satisfaction - statistics & numerical data; Prevalence; Prospective Studies; Schizophrenia - drug therapy; Schizophrenia - epidemiology; Sleep Initiation and Maintenance Disorders - chemically induced; Treatment Outcome; China
• ISSN: 0025-7974; 1536-5964
• DOI: 10.1097/MD.0000000000013688

This post hoc analysis of an open-label, single-arm, multicenter study was designed to assess the efficacy, safety, and tolerability of paliperidone extended release (ER) in Chinese patients with non-acute schizophrenia, after switching from olanzapine. Patients with schizophrenia who were dissatisfied with prior olanzapine treatment switched to flexible paliperidone ER (3-12 mg/day) based on clinical judgment. Change from baseline to week 12 in Positive and Negative Syndrome Scale (PANSS) total scores (primary endpoint), PANSS subscale scores, response rate, Clinical Global Impression-Severity (CGI-S) score, personal and social performance (PSP) scores, patient satisfaction with treatment score, change in sleep quality, level of daytime sleepiness and safety were evaluated. Out of 118 enrolled patients, 95 (81%) completed the study. Mean duration of study was 76.9 (23.85) days. The primary endpoint, mean (SD) PANSS total score changed significantly from baseline to endpoint (-19.6 [18.71], P <.0001). Secondary endpoints including PANSS subscale score, PSP, patient satisfaction and daytime drowsiness also significantly improved (P <.001). Most commonly reported (≥1%) treatment-emergent adverse events were akathisia (n = 14 [12%]) and insomnia (n = 9 [8%]). Switching to flexible-dosed paliperidone ER in patients dissatisfied with prior olanzapine treatment achieved good efficacy and tolerability consistently over 12 weeks.