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. 2016 Jan 8:12:69-77.
doi: 10.2147/NDT.S88875. eCollection 2016.

Safety and efficacy of paliperidone extended-release in Chinese patients with schizophrenia: a 24-week, open-label extension of a randomized, double-blind, placebo-controlled study

Hongyan Zhang  1 , Huafang Li  2 , Yanning Liu  3 , Cathy Wu  3 , Qingqi Wu  3 , Isaac Nuamah  4 , Jianguo Shi  5 , Shiping Xie  6 , Gang Wang  7 , Srihari Gopal  4
Affiliations

Safety and efficacy of paliperidone extended-release in Chinese patients with schizophrenia: a 24-week, open-label extension of a randomized, double-blind, placebo-controlled study

Hongyan Zhang et al. Neuropsychiatr Dis Treat. .

Abstract

Objectives: The long-term safety, tolerability, and efficacy of paliperidone extended-release (ER) were evaluated in Chinese patients with schizophrenia.

Methods: Patients (aged ≥18 years) with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria) who had completed run-in (8-week), stabilization (6-week), and double-blind (DB) phases (variable) of a phase-3, placebo-controlled study entered this 24-week, open-label extension (OLE) study. These patients, who had either experienced a relapse or remained relapse-free through DB phase of the study, were treated with flexible-dose paliperidone-ER (3-12 mg/day) during the OLE phase. Major safety evaluations included treatment-emergent adverse events (TEAEs) and extrapyramidal symptoms. Efficacy endpoints included changes in Positive and Negative Syndrome Scale total score, Clinical Global Impression-Severity scale, and Personal and Social Performance scale from OLE baseline to OLE endpoint.

Results: Out of 106 patients who entered the OLE phase (placebo: 59, paliperidone-ER: 47), a total of 85 (80%) completed it. Thirty-five (33%) patients experienced at least one TEAE; most common were akathisia, somnolence, nasopharyngitis, and constipation (3.8% each). Serious TEAEs were noted in two patients (completed suicide; schizophrenia worsening). No TEAEs with an onset during the OLE phase led to discontinuation. Extrapyramidal symptoms related-TEAEs were reported in eight (7.5%) patients. Mean (standard deviation) changes in Positive and Negative Syndrome Scale total scores (-10.4 [13.2]), Clinical Global Impression-Severity scores (-0.6 [0.96]) and Personal and Social Performance scores (7.4 [13.2]) from OLE baseline to OLE endpoint showed patients who had been treated with placebo during the DB phase experienced more pronounced improvements.

Conclusion: In this OLE study, flexibly dosed paliperidone-ER (3-12 mg/day) was tolerable and efficacious in Chinese patients with schizophrenia.

Keywords: CGI-S score; PANSS score; PSP score; paliperidone.

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Figures

Figure 1
Figure 1
Study design and patient disposition. Abbreviations: Pbo, placebo; Pali, paliperidone extended-release.
Figure 2
Figure 2
Arithmetic mean (±SE) PANSS total score over time – LOCF (run-in, stabilization, DB, OLE). Abbreviations: BL, baseline; DB, double-blind; LOCF, last observation carried forward; OLE, open-label extension; PANSS, Positive and Negative Syndrome Scale; Pali, paliperidone; ER, extended release; Pbo, placebo; RI, run-in; SE, standard error; ST, stabilization.
Figure 3
Figure 3
CGI-S frequency at baseline (run-in), baseline (DB), baseline (OLE) and endpoint (OLE). Abbreviations: OLE, open-label extension; Pbo, placebo; Pali, paliperidone extended-release; CGI-S, Clinical Global Impression-Severity; DB, double-blind; RI, run-in.
Figure 4
Figure 4
Arithmetic mean (±SE) PSP score over time – LOCF (run-in, stabilization, DB, OLE). Abbreviations: SE, standard error; PSP, personal and social performance; LOCF, last observation carried forward; BL, baseline; OLE, open-label extension; Pbo, placebo; Pali, paliperidone; ER, extended release; CGI-S, Clinical Global Impression-Severity; DB, double-blind; RI, run-in; ST, stabilization.
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