Cargando…
Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance
Schizophrenia is an unexplained, complex and serious mental illness. Blonanserin (BNS) is a new antipsychotic drug widely used in the treatment of schizophrenia. However, large-scale clinical studies have not been conducted in China. A multi-center, prospective, open-label, 12-week surveillance was...
Autores principales: | , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9435526/ https://www.ncbi.nlm.nih.gov/pubmed/36061293 http://dx.doi.org/10.3389/fpsyt.2022.935769 |
_version_ | 1784781161778642944 |
---|---|
author | Wu, Haishan Wang, Xijin Liu, Xuejun Sang, Hong Bo, Qijing Yang, Xiaodong Xun, Zhiyuan Li, Keqing Zhang, Ruiling Sun, Meijuan Cai, Duanfang Deng, Huaili Zhao, Guijun Li, Juhong Liu, Xianglai Zhan, Guilai Chen, Jindong |
author_facet | Wu, Haishan Wang, Xijin Liu, Xuejun Sang, Hong Bo, Qijing Yang, Xiaodong Xun, Zhiyuan Li, Keqing Zhang, Ruiling Sun, Meijuan Cai, Duanfang Deng, Huaili Zhao, Guijun Li, Juhong Liu, Xianglai Zhan, Guilai Chen, Jindong |
author_sort | Wu, Haishan |
collection | PubMed |
description | Schizophrenia is an unexplained, complex and serious mental illness. Blonanserin (BNS) is a new antipsychotic drug widely used in the treatment of schizophrenia. However, large-scale clinical studies have not been conducted in China. A multi-center, prospective, open-label, 12-week surveillance was carried out to evaluate the safety and effectiveness of BNS in patients with schizophrenia in China. Safety assessments included adverse drug reactions (ADRs), extrapyramidal symptoms (EPS), akathisia, concomitant medications for EPS by the end of treatment, and the changes in body weight from baseline by the end of treatment. The effectiveness was evaluated by the Brief Psychiatric Rating Scale (BPRS). From September 2018 to May 2020, of the 1,060 patients enrolled, 1,018 were included in the full analysis set (FAS) and safety set (SS), respectively. ADRs were developed in 205 patients among the included, the incidence being 20.1%. ADRs of EPS occurred in 169 patients, the incidence being 16.6%, ADRs of akathisia occurred in 90 patients, the incidence being 8.8%; concomitant therapeutic and prophylactic agents for EPS accounts for 19.2%; 4.0% of patients had a ≥7% increase in body weight from baseline at 12 weeks after initiating treatment. Using the last-observation-carried-forward (LOCF) method, the changes in total BPRS scores were −11.2 ± 10.17 (N = 1,018), −16.8 ± 12.69 (N = 1,018) and −20.6 ± 13.99 (N = 1,018) after 2/4, 6/8, or 12 weeks, respectively. 53.5% (545/1,018) patients showed response to blonanserin treatment in week 12. The post-marketing surveillance results of BNS demonstrates safety profile and effectiveness of the drug. |
format | Online Article Text |
id | pubmed-9435526 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-94355262022-09-02 Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance Wu, Haishan Wang, Xijin Liu, Xuejun Sang, Hong Bo, Qijing Yang, Xiaodong Xun, Zhiyuan Li, Keqing Zhang, Ruiling Sun, Meijuan Cai, Duanfang Deng, Huaili Zhao, Guijun Li, Juhong Liu, Xianglai Zhan, Guilai Chen, Jindong Front Psychiatry Psychiatry Schizophrenia is an unexplained, complex and serious mental illness. Blonanserin (BNS) is a new antipsychotic drug widely used in the treatment of schizophrenia. However, large-scale clinical studies have not been conducted in China. A multi-center, prospective, open-label, 12-week surveillance was carried out to evaluate the safety and effectiveness of BNS in patients with schizophrenia in China. Safety assessments included adverse drug reactions (ADRs), extrapyramidal symptoms (EPS), akathisia, concomitant medications for EPS by the end of treatment, and the changes in body weight from baseline by the end of treatment. The effectiveness was evaluated by the Brief Psychiatric Rating Scale (BPRS). From September 2018 to May 2020, of the 1,060 patients enrolled, 1,018 were included in the full analysis set (FAS) and safety set (SS), respectively. ADRs were developed in 205 patients among the included, the incidence being 20.1%. ADRs of EPS occurred in 169 patients, the incidence being 16.6%, ADRs of akathisia occurred in 90 patients, the incidence being 8.8%; concomitant therapeutic and prophylactic agents for EPS accounts for 19.2%; 4.0% of patients had a ≥7% increase in body weight from baseline at 12 weeks after initiating treatment. Using the last-observation-carried-forward (LOCF) method, the changes in total BPRS scores were −11.2 ± 10.17 (N = 1,018), −16.8 ± 12.69 (N = 1,018) and −20.6 ± 13.99 (N = 1,018) after 2/4, 6/8, or 12 weeks, respectively. 53.5% (545/1,018) patients showed response to blonanserin treatment in week 12. The post-marketing surveillance results of BNS demonstrates safety profile and effectiveness of the drug. Frontiers Media S.A. 2022-08-18 /pmc/articles/PMC9435526/ /pubmed/36061293 http://dx.doi.org/10.3389/fpsyt.2022.935769 Text en Copyright © 2022 Wu, Wang, Liu, Sang, Bo, Yang, Xun, Li, Zhang, Sun, Cai, Deng, Zhao, Li, Liu, Zhan and Chen. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Psychiatry Wu, Haishan Wang, Xijin Liu, Xuejun Sang, Hong Bo, Qijing Yang, Xiaodong Xun, Zhiyuan Li, Keqing Zhang, Ruiling Sun, Meijuan Cai, Duanfang Deng, Huaili Zhao, Guijun Li, Juhong Liu, Xianglai Zhan, Guilai Chen, Jindong Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance |
title | Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance |
title_full | Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance |
title_fullStr | Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance |
title_full_unstemmed | Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance |
title_short | Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance |
title_sort | safety and effectiveness of blonanserin in chinese patients with schizophrenia: an interim analysis of a 12-week open-label prospective multi-center post-marketing surveillance |
topic | Psychiatry |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9435526/ https://www.ncbi.nlm.nih.gov/pubmed/36061293 http://dx.doi.org/10.3389/fpsyt.2022.935769 |
work_keys_str_mv | AT wuhaishan safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT wangxijin safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT liuxuejun safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT sanghong safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT boqijing safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT yangxiaodong safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT xunzhiyuan safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT likeqing safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT zhangruiling safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT sunmeijuan safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT caiduanfang safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT denghuaili safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT zhaoguijun safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT lijuhong safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT liuxianglai safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT zhanguilai safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance AT chenjindong safetyandeffectivenessofblonanserininchinesepatientswithschizophreniaaninterimanalysisofa12weekopenlabelprospectivemulticenterpostmarketingsurveillance |