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

Abstract

PurposePaliperidone 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 methodsThis 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.ResultsOf 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.ConclusionSwitching 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.

Effects on Satisfaction and Service Engagement of Paliperidone Palmitate Compared with Oral Paliperidone in Patients with Schizophrenia: An Open Label Randomized Controlled Trial

“…In our trial we found that PP1M had an overall efficacy overlapping with paliperidone ER on clinical symptoms assessed with the CGI-SCH score, psychosocial functioning, measured with the PSP score, and on subjective wellbeing under neuroleptic, assessed with the SWN-K score. This result is in accordance with previous studies on oral paliperidone (12,(25)(26)(27) and long-acting paliperidone (23,24,28,39,40). In our study we did not observe a significant decrease of cognitive symptoms neither with PP1M, nor with paliperidone ER.…”

“…Efficacy of paliperidone extended release (ER) and paliperidone palmitate (PP1M) on clinical symptoms was investigated in several previous studies (12,(23)(24)(25)(26)(27)(28). The present open-label, randomized, controlled trial is aimed to evaluate the impact of treatment with once-monthly longacting paliperidone palmitate (PP1M) compared with oral paliperidone extended release (ER) on satisfaction, subjective well-being and service engagement in patients with non-acute symptomatic schizophrenia.…”

Design as sexual practice: The visual culture of social apps and HIV risk in Taiwan

“…For some time now, Taiwan has been praised for its social progressiveness on the LGBTQ front. Noted advances include its grassroots LGBTQ human social movements (Kao, 2021) since the 1990s; its vibrant gay market activities since the 2000s; its bellwether healthcare model, which was the first in East Asia to implement HIV prevention medicine pre-exposure prophylaxis (PrEP) in 2016; its 2017 landmark achievement of legalizing same-sex marriage (Chen et al, 2018;Laio, 2017;Ramzy, 2019). The progress achieved by these social movements, however, has not always aligned with manifestations of gay sexuality in social apps.…”

Factors impeding switching from clozapine to paliperidone among patients with chronic schizophrenia—A retrospective cohort study.

“…Since paliperidone is relatively new compared with other antipsychotics, switching from other antipsychotics to paliperidone may be an optional strategy, which raises concerns over the efficacy and tolerability. An open-label, multicenter study explored the tolerability and efficacy for patients who switched from other atypical antipsychotics to oral paliperidone (Chen, Tang, et al, 2018), however the factors associated with successful/failed switching were not estimated. Moreover, a major limitation of the study was that patients taking clozapine were excluded from the trial.…”