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Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study 期刊论文

编号：

1d9f510c-5469-401e-a74a-ee9bd8d7a4c5
作者：

Zhao, Jingping(赵靖平)#^[1]Li, Lehua(李乐华)#^[1]Shi, Jianguo^[2];Li, Yi^[3];Xu, Xiufeng(许秀峰)^[4]Li, Keqing(栗克清)^[5]Zhang, Lili^[6];Cai, Shangli(蔡尚立)^[6]Feng, Yu^[6];Zhuo, Jianmin^[6];Liu, Weihong^[6];Lu, Huafei*^[6]
语种：

英文
期刊：

NEUROPSYCHIATRIC DISEASE AND TREATMENT ISSN：1178-2021 2017 年 13 卷 (2045 - 2056)
收录：
关键词：

Chinese long-acting injectables open-label paliperidone palmitate PANSS schizophrenia
摘要：

Rationale: Long-acting injectable (LAI) paliperidone palmitate 1-month formulation (PP1M) has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest.
Objective: The aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia.
Methods: In this 25-week, open-label, Phase IV study, patients (18-65 years) diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS) total score of 60-120 (inclusive) were enrolled. All patients received injections of PP1M 150 mg eq. (day 1) and 100 mg eq. (day 8), followed by a flexible once-monthly maintenance dosing (75, 100, or 150 mg eq.).
Results: Of the 353 patients, 234 (66.3%) completed the study treatment (mean age, 31.1 years; 52.7% men). The PANSS total score (primary end point) improved significantly over the 6-month treatment period (mean [standard deviation] change from baseline to end of treatment, -27.2 [18.30]; P<0.0001). The Clinical Global Impressions-Severity and Personal and Social Performance scores (secondary end points) also improved significantly (P<0.0001). At 6 months, PP1M had a positive impact on medication satisfaction, adherence, and increased preference for LAIs. Treatment-emergent adverse events (TEAEs) were reported by 181 (51.3%) patients (TEAEs >= 5%: extrapyramidal disorder [15.3%], akathisia [10.5%], blood prolactin increase [8.8%], insomnia [5.4%]). A total of 8 deaths were reported, including 4 completed suicides.
Conclusion: Long-term treatment with PP1M was efficacious, and no new safety concerns were identified in Chinese patients with schizophrenia. Overall, the results were comparable with observations from previous studies.
推荐引用方式
GB/T 7714：

Zhao Jingping,Li Lehua,Shi Jianguo, et al. Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study [J].NEUROPSYCHIATRIC DISEASE AND TREATMENT,2017,13:2045-2056.
APA：

Zhao Jingping,Li Lehua,Shi Jianguo,Li Yi,&Lu Huafei.(2017).Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study .NEUROPSYCHIATRIC DISEASE AND TREATMENT,13:2045-2056.
MLA：

Zhao Jingping, et al. "Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study" .NEUROPSYCHIATRIC DISEASE AND TREATMENT 13(2017):2045-2056.
入库时间：

2020/4/13 14:53:42
更新时间：

2020/4/13 14:53:42
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