Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting.

IF 2.4 4区 医学 Q3 NEUROSCIENCES
Young-Chul Chung, Yen Kuang Yang, Ahmad Hatim Sulaiman, Paul Bergmans, Wilson Tan
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引用次数: 2

Abstract

Objective: To evaluate the long-term efficacy and safety of three-monthly paliperidone palmitate (PP3M) in Asian patients with stable schizophrenia in a naturalistic setting.

Methods: Asian patients recruited between May 2016 and March 2018 from the prospective, single-arm, non-randomized, open-label, multi-national REMISSIO study were analyzed. Patients received PP3M over 12 months following ≥ 4 months of treatment with one-monthly paliperidone palmitate. The primary efficacy endpoint was the proportion of patients who achieved symptomatic remission. Other endpoints were changes in Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance (PSP) total scores, hospitalization rates, and safety.

Results: A total of 71 patients (23.3%) were Asian (South Korea: 33, Malaysia: 21, Taiwan: 17); 95.8% of patients completed the study. At LOCF, 71% of Asian patients achieved symptomatic remission compared to the overall population (n = 172/303, 56.8%). Improvements in mean (standard deviation) PANSS and PSP total scores from baseline to LOCF in Asian patients and overall population were clinically significant. A lower proportion of Asian patients had ≥ 1 psychiatric hospitalization after PP3M treatment (n = 1/70, 1.4%) than during the 12 months before (n = 12/70, 17.1%); compared with patients in the overall population after (n = 8/303, 2.6%) and before PP3M treatment (n = 37/303, 12.2%). The overall incidence of treatment-emergent adverse events across Asian patients was 62.9% compared to 53.1% in the overall population. Safety findings were consistent with the known safety profile of PP3M.

Conclusion: Our findings confirm existing evidence on the efficacy and tolerability of PP3M in Asian patients with stable schizophrenia over 12 months of treatment.

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REMISSIO研究的亚洲亚组分析:在自然临床环境下,稳定型精神分裂症患者服用棕榈酸帕利哌酮3个月的长期疗效和安全性研究。
目的:评价在自然环境下,3个月服用棕榈酸帕利哌酮(PP3M)治疗亚洲稳定型精神分裂症患者的长期疗效和安全性。方法:分析2016年5月至2018年3月期间从前瞻性、单臂、非随机、开放标签、多国REMISSIO研究中招募的亚洲患者。患者在接受1个月棕榈酸帕利哌酮治疗≥4个月后,在12个月内接受PP3M治疗。主要疗效终点是达到症状缓解的患者比例。其他终点是阳性和阴性综合征量表(PANSS)、个人和社会表现(PSP)总分、住院率和安全性的变化。结果:亚洲患者71例(23.3%),其中韩国33例,马来西亚21例,台湾17例;95.8%的患者完成了研究。在LOCF,与总体人群相比,71%的亚洲患者获得了症状缓解(n = 172/303, 56.8%)。亚洲患者和总体人群从基线到LOCF的平均(标准差)PANSS和PSP总分的改善具有临床意义。亚洲患者在PP3M治疗后有≥1次精神住院的比例(n = 1/70, 1.4%)低于治疗前12个月(n = 12/70, 17.1%);与PP3M治疗后(n = 8/303, 2.6%)和治疗前(n = 37/303, 12.2%)的总体患者进行比较。亚洲患者在治疗中出现的不良事件的总发生率为62.9%,而在总人口中为53.1%。安全性调查结果与PP3M已知的安全性一致。结论:我们的研究结果证实了PP3M在亚洲稳定型精神分裂症患者治疗12个月后的疗效和耐受性。
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来源期刊
Clinical Psychopharmacology and Neuroscience
Clinical Psychopharmacology and Neuroscience NEUROSCIENCESPHARMACOLOGY & PHARMACY-PHARMACOLOGY & PHARMACY
CiteScore
4.70
自引率
12.50%
发文量
81
期刊介绍: Clinical Psychopharmacology and Neuroscience (Clin Psychopharmacol Neurosci) launched in 2003, is the official journal of The Korean College of Neuropsychopharmacology (KCNP), and the associate journal for Asian College of Neuropsychopharmacology (AsCNP). This journal aims to publish evidence-based, scientifically written articles related to clinical and preclinical studies in the field of psychopharmacology and neuroscience. This journal intends to foster and encourage communications between psychiatrist, neuroscientist and all related experts in Asia as well as worldwide. It is published four times a year at the last day of February, May, August, and November.
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