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Clinical Trial
. 2019 Jan;98(3):e13688.
doi: 10.1097/MD.0000000000013688.

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

Affiliations
Clinical Trial

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

Tian Mei Si et al. Medicine (Baltimore). 2019 Jan.

Abstract

Objective: 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.

Methods: 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.

Results: 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%]).

Conclusions: Switching to flexible-dosed paliperidone ER in patients dissatisfied with prior olanzapine treatment achieved good efficacy and tolerability consistently over 12 weeks.

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References

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