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. 2018 Mar 8:14:725-732.
doi: 10.2147/NDT.S161186. eCollection 2018.

Efficacy, tolerability, and safety of oral paliperidone extended release in the treatment of schizophrenia: a 24-week, open-label, prospective switch study in different settings in Taiwan

Ching-Yen Chen  1   2 , Tze-Chun Tang  3 , Tzu-Ting Chen  4 , Ya Mei Bai  5   6 , Huei-Huang Tsai  7 , Hou-Liang Chen  7 , Chun-Jen Huang  8   9 , Chih-Ken Chen  1   2 , Chun-Chih Chen  10 , Mei-Chun Hsiao  11 , Chia-Yih Liu  2   12 , Hong-Shiow Yeh  13 , Nan-Ying Chiu  10 , Cheng-Chen Hsiao  14 , Cheng-Sheng Chen  8   9 , Tung-Ping Su  5   15   16
Affiliations

Efficacy, tolerability, and safety of oral paliperidone extended release in the treatment of schizophrenia: a 24-week, open-label, prospective switch study in different settings in Taiwan

Ching-Yen Chen et al. Neuropsychiatr Dis Treat. .

Abstract

Purpose: Paliperidone extended release (ER) is an oral psychotropic treatment formulated to release paliperidone at a controlled, gradually ascending rate. We evaluated the efficacy and safety of switching to paliperidone ER in Taiwanese patients with schizophrenia who were unresponsive or intolerant to previous antipsychotic therapy.

Patients and methods: This was a 24-week, open-label, single-arm, multicenter, Phase IV trial. Based on consulting psychiatrists' judgment, patients were deemed eligible for the switch to paliperidone ER; the switch was achieved by cross-tapering, using a recommended starting dose of 6 mg. Eligibility considerations included lack of efficacy, tolerability, and/or adherence to previous oral antipsychotic medication.

Results: Of the 297 enrolled patients, 178 (59.5%) completed the study. The main reasons for discontinuation included insufficient efficacy (8.7%), patient decision (8.4%), and adverse events (AEs; 6.4%). Improvements in the: Positive and Negative Syndrome Scale total score and Clinical Global Impression-Severity score were observed only in patients treated at medical centers and not in those treated at psychiatric hospitals. The most common AEs were insomnia, headache, constipation, and extrapyramidal syndrome. One or more serious AEs were reported in 11 (3.7%) patients; none resulted in death. No significant changes in body weight, plasma glucose, or lipid levels were observed.

Conclusion: Switching to paliperidone ER was effective and well tolerated for up to 24 weeks in patients with schizophrenia who were unresponsive or intolerant to previous antipsychotic therapy. The observed differences in treatment between psychiatric hospitals and medical centers with regard to dosage and titration of paliperidone ER warrant further investigation.

Keywords: open-label; paliperidone extended release; prospective; schizophrenia; settings; switch study.

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Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Mean PANSS total score up to week 24. Notes: Progressive decrease in the mean PANSS total score in patients with schizophrenia who switched to paliperidone extended release (ER) from baseline to week 24. ITT, n = 297, *p < 0.0001 vs baseline. Abbreviations: ITT, intention to treat; PANSS, Positive and Negative Syndrome Scale.
Figure 2
Figure 2
Mean PANSS total score and CGI-S score for patients in medical centers and psychiatric hospitals. Notes: Mean Positive and Negative Syndrome Scale (PANSS) total score and mean Clinical Global Impression-Severity (CGI-S) score in patients with schizophrenia who switched to paliperidone extended release (ER) grouped by facility type (medical center or psychiatric hospital) at baseline and week 24. Mean scores significantly decreased from baseline only in patients treated at medical centers.
Figure 3
Figure 3
Paliperidone ER dose distribution for patients in medical centers and psychiatric hospitals. Note: Differences in distribution of dose of paliperidone extended release (ER) administered to patients with schizophrenia who switched from an other therapy, by facility type (medical center or psychiatric hospital), from baseline to week 24.
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