Safety and effectiveness of oral medium to high dose blonanserin in patients with schizophrenia: subgroup analysis from a prospective, multicenter, post-marketing surveillance study in mainland China
-
Published:2023-10-06
Issue:1
Volume:22
Page:
-
ISSN:1744-859X
-
Container-title:Annals of General Psychiatry
-
language:en
-
Short-container-title:Ann Gen Psychiatry
Author:
Yang Yuan,Ge Hongmin,Wang Xijin,Liu Xuejun,Li Keqing,Wang Gang,Yang Xiaodong,Deng Huaili,Sun Meijuan,Zhang Ruiling,Chen Jindong,Cai Duanfang,Sang Hong,Liu Xianglai,Zhan Guilai,Zhao Guijun,Li Haiyun,Xun Zhiyuan
Abstract
Abstract
Background
Blonanserin (BNS) had been undergoing post-market surveillance (PMS) since September 2018. Using the surveillance data, we did this analysis to assess the safety and effectiveness of different doses of BNS to explore a sufficient dose range of BNS in Chinese patients with schizophrenia (SZ).
Methods
A 12-week, prospective, observational, single-arm, multicenter, open-label PMS was conducted. In this analysis, we divided the patients from PMS into low, medium to high, and high dose groups based on the dose of BNS they received, with medium to high dose group being the focus. The Brief Psychiatric Rating Scale (BPRS) scores at week 2 or 4, 6 or 8, and 12 were calculated to evaluate the effectiveness of BNS in improving psychiatric symptoms. The safety of BNS was reported as the incidence of adverse drug reactions.
Results
364 patients were included in the medium to high dose group, of which 321 completed the surveillance, with a dropout rate of 11.8%. The mean daily dose was 15.1 ± 1.92 mg. The BPRS total score was 50.1 ± 11.95 at baseline and decreased to 26.6 ± 7.43 at 12 weeks (P < 0.001). When compared with other groups, the median to high dose group achieved significantly more reduction in BPRS score at week 12 (P = 0.004 versus low dose and P = 0.033 versus higher dose). Extrapyramidal symptoms [EPS (46.4%)] were the most common adverse reactions in the medium to high group. The average weight gain during the surveillance was 0.5 ± 2.56 kg and prolactin elevation occurred in 2.2% patients. Most adverse reactions were mild.
Conclusions
BNS at medium to high doses (mean 15.1 mg/d) significantly improved symptoms of SZ and was well-tolerated. Most ADRs were mild, and the likelihood of causing metabolic side effects and prolactin elevations was low. Medium to high dose of BNS is a more potent treatment choice for SZ.
Trial registration number: ChiCTR2100048734. Date of registration: 2021/07/15 (retrospectively registered).
Publisher
Springer Science and Business Media LLC
Subject
Psychiatry and Mental health
Reference23 articles.
1. Huang Y, Wang Y, Wang H, Liu Z, Yu X, Yan J, et al. Prevalence of mental disorders in China: a cross-sectional epidemiological study. The lancet Psychiatry. 2019;6(3):211–24.
2. Zhao J. Chinese guidelines for the prevention and treatment of schizophrenia. 2nd ed. Beijing: Chinese Medical Multimedia Press; 2015.
3. Hasan A, Falkai P, Wobrock T, Lieberman J, Glenthoj B, Gattaz WF, et al. World federation of societies of biological psychiatry (WFSBP) guidelines for biological treatment of schizophrenia, part 1: update 2012 on the acute treatment of schizophrenia and the management of treatment resistance. World J Biol Psychiatry. 2012;13(5):318–78.
4. Mao J, Zhang C, Ou Y, Zhang J. Comparison of different doses of risperidone in patients with schizophrenia. Chron Pathematol J. 2022;23(05):774–6+80.
5. Li C, Xia J, Wang J. Risperidone dose for schizophrenia. Cochrane Database Syst Rev. 2009;4:CD007474.