Effectiveness and safety of blonanserin in young and middle-aged female patients with schizophrenia: data from a post-marketing surveillance
Abstract Background A post-marketing surveillance of blonanserin has been ongoing since September 2018. The aim of this study was to assess the effectiveness and safety of oral blonanserin in Chinese young and middle-aged female patients with schizophrenia in real clinical settings, using the data f...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | BMC Psychiatry |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12888-023-04598-y |
| _version_ | 1827983135242977280 |
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| author | Qijing Bo Xijin Wang Xuejun Liu Hong Sang Zhiyuan Xun Ruiling Zhang Xiaodong Yang Huaili Deng Keqing Li Jindong Chen Meijuan Sun Guijun Zhao Xianglai Liu Duanfang Cai Guilai Zhan Juhong Li Haiyun Li Gang Wang |
| author_facet | Qijing Bo Xijin Wang Xuejun Liu Hong Sang Zhiyuan Xun Ruiling Zhang Xiaodong Yang Huaili Deng Keqing Li Jindong Chen Meijuan Sun Guijun Zhao Xianglai Liu Duanfang Cai Guilai Zhan Juhong Li Haiyun Li Gang Wang |
| author_sort | Qijing Bo |
| collection | DOAJ |
| description | Abstract Background A post-marketing surveillance of blonanserin has been ongoing since September 2018. The aim of this study was to assess the effectiveness and safety of oral blonanserin in Chinese young and middle-aged female patients with schizophrenia in real clinical settings, using the data from the post-marketing surveillance. Methods A 12-week, prospective, multi-center, open-label, post-marketing surveillance was conducted. Female patients aged 18–40 years were included in this analysis. The Brief Psychiatric Rating Scale (BPRS) was used to evaluate the effectiveness of blonanserin in improving psychiatric symptoms. The incidence of adverse drug reactions (ADRs) such as of extrapyramidal symptoms (EPS), prolactin elevation and the weight gain were used to evaluate the safety profile of blonanserin. Results A total of 392 patients were included both in the safety and full analysis sets, 311 patients completed the surveillance protocol. The BPRS total score was 48.8 ± 14.11 at the baseline, decreasing to 25.5 ± 7.56 at 12 weeks (P < 0.001, compared with baseline). EPS (20.2%) including akathisia, tremor, dystonia, and parkinsonism were found as the most frequent ADRs. The mean weight gain was 0.27 ± 2.5 kg at 12 weeks from the baseline. Four cases (1%) of prolactin elevation were observed during the period of surveillance. Conclusion Blonanserin significantly improved the symptoms of schizophrenia in female patients aged 18–40 years; the drug was well tolerated and had a low tendency to cause metabolic side effects, including prolactin elevation in these patients. Blonanserin might be a reasonable drug for the treatment of schizophrenia in young and middle-aged female patients. |
| first_indexed | 2024-04-09T22:44:02Z |
| format | Article |
| id | doaj.art-a83bc3dda3b142aea5978dbccef6f415 |
| institution | Directory Open Access Journal |
| issn | 1471-244X |
| language | English |
| last_indexed | 2024-04-09T22:44:02Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj.art-a83bc3dda3b142aea5978dbccef6f4152023-03-22T12:00:41ZengBMCBMC Psychiatry1471-244X2023-02-012311810.1186/s12888-023-04598-yEffectiveness and safety of blonanserin in young and middle-aged female patients with schizophrenia: data from a post-marketing surveillanceQijing Bo0Xijin Wang1Xuejun Liu2Hong Sang3Zhiyuan Xun4Ruiling Zhang5Xiaodong Yang6Huaili Deng7Keqing Li8Jindong Chen9Meijuan Sun10Guijun Zhao11Xianglai Liu12Duanfang Cai13Guilai Zhan14Juhong Li15Haiyun Li16Gang Wang17The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical UniversityDepartment of Psychiatry, The First Psychiatric Hospital of HarbinDepartment of Psychiatry, Brain Hospital of Hunan ProvinceMental Health Center, Changchun Sixth HospitalDepartment of Psychiatry, Tianjin Anding HospitalDepartment of Psychiatry, Henan Mental HospitalDepartment of Psychiatry, Shandong Mental Health CenterDepartment of Psychology, Psychiatric Hospital of Taiyuan CityDepartment of Psychiatry, Hebei Provincial Mental Health CenterDepartment of Psychiatry, National Clinical Research Center for Mental Disorders, The Second Xiangya Hospital of Central South UniversityDepartment of Pharmacy, Daqing Third HospitalDepartment of Psychiatry, Guangyuan Mental Health CenterInstitute of Mental Health, Hainan Provincial Anning HospitalDepartment of Psychiatry, The Fifth People’s Hospital of ZigongDepartment of Psychiatry, Xuhui Mental Health centerDepartment of Psychiatry, The Fourth People’s Hospital of ChengduMedical Affairs, Sumitomo Pharma (Suzhou) Co., LtdAdvanced Innovation Center for Human Brain Protection, Capital Medical UniversityAbstract Background A post-marketing surveillance of blonanserin has been ongoing since September 2018. The aim of this study was to assess the effectiveness and safety of oral blonanserin in Chinese young and middle-aged female patients with schizophrenia in real clinical settings, using the data from the post-marketing surveillance. Methods A 12-week, prospective, multi-center, open-label, post-marketing surveillance was conducted. Female patients aged 18–40 years were included in this analysis. The Brief Psychiatric Rating Scale (BPRS) was used to evaluate the effectiveness of blonanserin in improving psychiatric symptoms. The incidence of adverse drug reactions (ADRs) such as of extrapyramidal symptoms (EPS), prolactin elevation and the weight gain were used to evaluate the safety profile of blonanserin. Results A total of 392 patients were included both in the safety and full analysis sets, 311 patients completed the surveillance protocol. The BPRS total score was 48.8 ± 14.11 at the baseline, decreasing to 25.5 ± 7.56 at 12 weeks (P < 0.001, compared with baseline). EPS (20.2%) including akathisia, tremor, dystonia, and parkinsonism were found as the most frequent ADRs. The mean weight gain was 0.27 ± 2.5 kg at 12 weeks from the baseline. Four cases (1%) of prolactin elevation were observed during the period of surveillance. Conclusion Blonanserin significantly improved the symptoms of schizophrenia in female patients aged 18–40 years; the drug was well tolerated and had a low tendency to cause metabolic side effects, including prolactin elevation in these patients. Blonanserin might be a reasonable drug for the treatment of schizophrenia in young and middle-aged female patients.https://doi.org/10.1186/s12888-023-04598-yBlonanserinEffectivenessSafetyWomenSchizophrenia |
| spellingShingle | Qijing Bo Xijin Wang Xuejun Liu Hong Sang Zhiyuan Xun Ruiling Zhang Xiaodong Yang Huaili Deng Keqing Li Jindong Chen Meijuan Sun Guijun Zhao Xianglai Liu Duanfang Cai Guilai Zhan Juhong Li Haiyun Li Gang Wang Effectiveness and safety of blonanserin in young and middle-aged female patients with schizophrenia: data from a post-marketing surveillance BMC Psychiatry Blonanserin Effectiveness Safety Women Schizophrenia |
| title | Effectiveness and safety of blonanserin in young and middle-aged female patients with schizophrenia: data from a post-marketing surveillance |
| title_full | Effectiveness and safety of blonanserin in young and middle-aged female patients with schizophrenia: data from a post-marketing surveillance |
| title_fullStr | Effectiveness and safety of blonanserin in young and middle-aged female patients with schizophrenia: data from a post-marketing surveillance |
| title_full_unstemmed | Effectiveness and safety of blonanserin in young and middle-aged female patients with schizophrenia: data from a post-marketing surveillance |
| title_short | Effectiveness and safety of blonanserin in young and middle-aged female patients with schizophrenia: data from a post-marketing surveillance |
| title_sort | effectiveness and safety of blonanserin in young and middle aged female patients with schizophrenia data from a post marketing surveillance |
| topic | Blonanserin Effectiveness Safety Women Schizophrenia |
| url | https://doi.org/10.1186/s12888-023-04598-y |
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