@article{ref1,
title="Relapse prevention study of paliperidone extended-release tablets in Chinese patients with schizophrenia",
journal="Progress in neuro-psychopharmacology and biological psychiatry",
year="2014",
author="Rui, Q. and Wang, Y. and Liang, S. and Liu, Y. and Wu, Y. and Wu, Q. and Nuamah, I. and Gopal, S.",
volume="53",
number="",
pages="45-53",
abstract="OBJECTIVES: The objective of this study was to evaluate the long-term efficacy, safety, and tolerability of paliperidone extended-release (pali ER), in Chinese patients with schizophrenia. <br><br>METHODS: In this parallel-group, relapse prevention, phase-3 study (screening [14-day], pali ER open-label run-in [8-week] and stabilization [6-week] phases, and double-blind (DB) treatment [variable duration], and open-label extension phases [24-week]), 136/201 patients with schizophrenia were randomized (1:1) to pali ER (3-12. mg) or placebo during the DB phase. <br><br>RESULTS: Final analysis showed that, out of 135 patients in ITT (DB) population, 71 (52.6%) had a relapse event, 45 (33.3%) were ongoing at the time the study was stopped, and 19 (14.1%) discontinued from the DB phase. Time to relapse (primary endpoint) favored pali ER (hazard ratio. = 5.23 [95% CI: 2.96, 9.25], p < 0.0001). Rate of relapses (55/71 [77.5%] placebo; 16/64 [25%] pali ER) and secondary endpoints (change from baseline in Positive And Negative Syndrome Scale [PANSS] and Clinical Global Impression - Severity Scores) were significantly lower (p. < 0.001) in pali ER group vs placebo, in favor of pali ER. More psychiatric-related treatment-emergent adverse events (TEAEs) occurred in placebo- (21.1%) than pali ER group (10.9%). Most common (>. 3%) TEAEs in placebo group were insomnia and schizophrenia (8.5% each), while in pali ER group were aggression and akathisia (4.7% each), and schizophrenia, tremor, nausea, amenorrhea, and salivary hypersecretion (3.1% each). All serious TEAEs were psychiatric-related (schizophrenia, aggression, completed suicide, auditory hallucination, suicide attempt) and more frequent in placebo- (11.3%) versus pali ER group (3.1%). Death and tardive dyskinesia-related discontinuation (n = 1 each) occurred in placebo group. Body weight increase from run-in baseline was greater in pali ER group (mean increase: 3.90. kg) versus placebo (mean increase: 2.05. kg). <br><br>CONCLUSIONS: This study confirms the findings from earlier pali ER global relapse-prevention studies and demonstrates that pali ER treatment (3-12. mg) is efficacious over the long-term and significantly delays relapse in Chinese patients with schizophrenia. No new safety signals were detected in this population. © 2014 The Authors.<p /><p>Language: en</p>",
language="en",
issn="0278-5846",
doi="10.1016/j.pnpbp.2014.02.007",
url="http://dx.doi.org/10.1016/j.pnpbp.2014.02.007"
}