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Relapse prevention study of paliperidone extended-release tablets in Chinese patients with schizophrenia

2014; Elsevier BV; Volume: 53; Linguagem: Inglês

10.1016/j.pnpbp.2014.02.007

1878-4216

Qing Rui, Yang Wang, Liang Shu, Yanning Liu, Yue Wu, Qingqi Wu, Isaac Nuamah, Srihari Gopal,

Gastrointestinal motility and disorders

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.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.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 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).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.