|Relapse prevention study of paliperidone eltended-release tablets in Chinese patients with schizophrenia|
|Rui, Qing1; Wang, Yang1; Liang, Shu2; Liu, Yanning1; Wu, Yue1; Wu, Qingqi1; Nuamah, Isaac3; Gopal, Srihari3|
|关键词||Chinese Paliperidone Schizophrenia Symptoms Time To Relapse|
|刊名||PROGRESS IN NEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY|
|WOS标题词||Science & Technology|
|类目[WOS]||Clinical Neurology ; Neurosciences ; Pharmacology & Pharmacy ; Psychiatry|
|研究领域[WOS]||Neurosciences & Neurology ; Pharmacology & Pharmacy ; Psychiatry|
|关键词[WOS]||OPEN-LABEL ; RISPERIDONE ; SAFETY ; HALOPERIDOL ; EFFICACY ; PLACEBO ; ARIPIPRAZOLE ; ER|
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.
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 pall ER (3-12 mg) or placebo during the DB phase.
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- (113%) 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).
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. (C) 2014 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).
|资助机构||Janssen Research & ; Development, LLC.|
|作者单位||1.Janssen Res & Dev LLC, Titusville, NJ USA|
2.Janssen Res & Dev, Beijing, Peoples R China
3.Peking Univ, Hosp 6, Beijing 100871, Peoples R China
|Rui, Qing,Wang, Yang,Liang, Shu,et al. Relapse prevention study of paliperidone eltended-release tablets in Chinese patients with schizophrenia[J]. PROGRESS IN NEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY,2014,53:45-53.|
|APA||Rui, Qing.,Wang, Yang.,Liang, Shu.,Liu, Yanning.,Wu, Yue.,...&Gopal, Srihari.(2014).Relapse prevention study of paliperidone eltended-release tablets in Chinese patients with schizophrenia.PROGRESS IN NEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY,53,45-53.|
|MLA||Rui, Qing,et al."Relapse prevention study of paliperidone eltended-release tablets in Chinese patients with schizophrenia".PROGRESS IN NEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY 53(2014):45-53.|