Observational Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Psychiatry. Nov 19, 2023; 13(11): 937-948
Published online Nov 19, 2023. doi: 10.5498/wjp.v13.i11.937
Safety and effectiveness of lurasidone in the treatment of Chinese schizophrenia patients: An interim analysis of post-marketing surveillance
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
Yu-Mei Wei, Shanghai Clinical Research Center for Mental Health, School of Medicine, Shanghai Jiao Tong University, Shanghai 200030, China
Xi-Jin Wang, Department of Psychiatry, The First Psychiatric Hospital of Harbin, Harbin 150056, Heilongjiang Province, China
Xiao-Dong Yang, Department of Psychiatry, Shandong Provincial Mental Health Center, Jinan 250014, Shandong Province, China
Chuan-Sheng Wang, Department of Psychiatry, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang 453002, Henan Province, China
Li-Li Wang, Department of Psychiatry, Tianjin Mental Health Center, Tianjin Anding Hospital, Tianjin 300222, China
Xiao-Ying Xu, Department of Psychiatry, The Fifth People’s Hospital of Zigong, Zigong 643020, Sichuan Province, China
Gui-Jun Zhao, Department of Psychiatry, Guangyuan Mental Health Center, Guangyuan 628001, Guizhou Province, China
Bin Li, Department of Psychology, Fujian Energy General Hospital, Fuzhou 350001, Fujian Province, China
Dao-Min Zhu, 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
Qi Wu, Sumitomo Pharma (China), Co., Ltd., Shanghai 200025, China
Yi-Feng Shen, Shanghai Key Laboratory of Psychotic Disorders, Shanghai Clinical Research Center for Mental Health, Shanghai Jiao Tong University, Shanghai 200030, China
Author contributions: Wang XJ, Yang XD, Wang CS, Wang LL, Xu XY, Zhao GJ, Li B, Zhu DM and Shen YF contributed to data acquisition, data analysis and interpretation; Wei YM and Wu Q contributed to the study concept, design and data analysis; All authors read and approved the final manuscript.
Supported by 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.
Institutional review board statement: The study protocol was approved by the ethics committees of Shanghai Mental Health Center (the leading site) and other sites.
Informed consent statement: The patients were required to provide informed consent before participating.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Yi-Feng Shen, MD, PhD, Professor, Shanghai Key Laboratory of Psychotic Disorders, Shanghai Clinical Research Center for Mental Health, Shanghai Jiao Tong University, No. 600 Wanping Nan Road, Shanghai 200030, China, Shanghai 200030, China. shenyifeng@sina.com
Received: August 23, 2023
Peer-review started: August 23, 2023
First decision: September 28, 2023
Revised: October 11, 2023
Accepted: October 27, 2023
Article in press: October 27, 2023
Published online: November 19, 2023
ARTICLE HIGHLIGHTS
Research 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.

Research motivation

To further validate the safety profile and effectiveness of lurasidone.

Research objectives

To evaluate the safety and effectiveness of lurasidone in the Chinese population.

Research methods

We conducted a prospective, multicenter, open-label, 12-wk surveillance in mainland China, and reported the interim analysis based on 965 patients who received the medication between 2019 and 2022.

Research results

Mean changes in total brief psychiatric rating scale 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 visit compared with the baseline) using the last-observation-carried-forward method. adverse events and adverse drug reactions were experienced by 101 (11.3%) and 78 patients (8.7%), respectively, which were mostly mild.

Research conclusions

The interim analysis of the post-market surveillance demonstrate the safety and effectiveness of lurasidone in the Chinese population.

Research perspectives

This study contributes additional safety and effectiveness data on lurasidone, surpassing those obtained in pre-marketing trials. It offers essential guidance for clinical decision-making in the treatment of schizophrenia.