Safety and effectiveness of lurasidone in the treatment of Chinese schizophrenia patients:An interim analysis of post-marketing surveillance  

作　　者：Yu-Mei Wei Xi-Jin Wang Xiao-Dong Yang Chuan-Sheng Wang Li-Li Wang Xiao-Ying Xu Gui-Jun Zhao Bin Li Dao-Min Zhu Qi Wu Yi-Feng Shen 

机构地区：[1]Shanghai Clinical Research Center for Mental Health,School of Medicine,Shanghai Jiao Tong University,Shanghai 200030,China [2]Department of Psychiatry,The First Psychiatric Hospital of Harbin,Harbin 150056,Heilongjiang Province,China [3]Department of Psychiatry,Shandong Provincial Mental Health Center,Jinan 250014,Shandong Province,China [4]Department of Psychiatry,The Second Affiliated Hospital of Xinxiang Medical University,Xinxiang 453002,Henan Province,China [5]Department of Psychiatry,Tianjin Mental Health Center,Tianjin Anding Hospital,Tianjin 300222,China [6]Department of Psychiatry,The Fifth People’s Hospital of Zigong,Zigong 643020,Sichuan Province,China [7]Department of Psychiatry,Guangyuan Mental Health Center,Guangyuan 628001,Guizhou Province,China [8]Department of Psychology,Fujian Energy General Hospital,Fuzhou 350001,Fujian Province,China [9]Department of Sleep Disorders,Affiliated Psychological Hospital of Anhui Medical University,Hefei Fourth People’s Hospital,Anhui Mental Health Center,Hefei 230022,Anhui Province,China [10]Sumitomo Pharma(China),Co.,Ltd.,Shanghai 200025,China [11]Shanghai Key Laboratory of Psychotic Disorders,Shanghai Clinical Research Center for Mental Health,Shanghai Jiao Tong University,Shanghai 200030,China

出　　处：《World Journal of Psychiatry》2023年第11期937-948,共12页世界精神病学杂志

基　　金：Collaborative Innovation Center Project of Translational Medicine,Shanghai Jiaotong University School of Medicine,No.TM202116PT(2021-2023);Clinical Research Plan of SHDC,No.SHDC2022CRS032;and the Sumitomo Pharmaceuticals(Suzhou)Co.,Ltd.

摘　　要：BACKGROUND Schizophrenia is a psychiatric disorder characterized by chronic or recurrent symptoms.Lurasidone was licensed in China in 2019 for the treatment of adult schizophrenia in adults with a maximum dose of 80 mg/d.However,post-market surveillance(PMS)with an adequate sample size is required for further validation of the drug’s safety profile and effectiveness.AIM To conduct PMS in real-world clinical settings and evaluate the safety and effectiveness of lurasidone in the Chinese population.METHODS A prospective,multicenter,open-label,12-wk surveillance was conducted in China's Mainland.All patients with schizophrenia from 10 sites who had begun medication with lurasidone between September 2019 and August 2022 were eligible for enrollment.Safety assessments included adverse events(AEs),adverse drug reactions(ADRs),extrapyramidal symptoms(EPS),akathisia,use of EPS drugs,weight gain,and laboratory values as metabolic parameters and the QTc interval.The effectiveness was assessed using the brief psychiatric rating scale(BPRS)from baseline to the end of treatment.RESULTS A total of 965 patients were enrolled in the full analysis set and 894 in the safety set in this interim analysis.The average daily dose was 61.7±19.08 mg(mean±SD)during the treatment.AEs and ADRs were experienced by 101 patients(11.3%)and 78 patients(8.7%),respectively,which were mostly mild.EPS occurred in 25 individuals with a 2.8%incidence,including akathisia in 20 individuals(2.2%).Moreover,59 patients received drugs for treating EPS during the treatment,with an incidence of 6.6%which dropped to 5.4%at the end of the treatment.The average weight change was 0.20±2.36 kg(P=0.01687)with 0.8%of patients showing a weight gain of≥7%at week 12 compared with that at the baseline.The mean values of metabolic parameters and the QTc interval at baseline and week 12 were within normal ranges.The mean changes in total BPRS scores were-8.9±9.76(n=959),-13.5±12.29(n=959),and-16.8±13.97(n=959)after 2/4,6/8,and 12 wk,respectively(P<0.001 for each

关 键 词：LURASIDONE SAFETY EFFECTIVENESS SURVEILLANCE SCHIZOPHRENIA CHINESE 

分 类 号：R749.3[医药卫生—神经病学与精神病学]