Evidence map›Paper›PMID 37803378›Full record

ArticleAnnals of general psychiatry2023

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.

Yuan Yang, Hongmin Ge, Xijin Wang, Xuejun Liu, Keqing Li, Gang Wang, Xiaodong Yang, Huaili Deng, Meijuan Sun, Ruiling Zhang and 8 more

Open access · goldAbstract read
In one paragraph

Article in Annals of general psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 43% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 1 country.

Yuan Yang *Department of Psychiatry, Tianjin Anding Hospital, Hexi District, Tianjin, 300222, China.
Hongmin Ge *Department of Psychiatry, Tianjin Anding Hospital, Hexi District, Tianjin, 300222, China.
Xijin WangDepartment of Psychiatry, The First Psychiatric Hospital of Harbin, Harbin, Heilongjiang, China.
Xuejun LiuDepartment of Psychiatry, Brain Hospital of Hunan Province, Changsha, Hunan, China.
Keqing LiDepartment of Psychiatry, Hebei Provincial Mental Health Center, Baoding, Hebei, China.
Gang WangThe National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China.
Xiaodong YangDepartment of Psychiatry, Shandong Mental Health Center, Jinan, Shandong, China.
Huaili DengDepartment of Psychology, Psychiatric Hospital of Taiyuan City, Taiyuan, Shanxi, China.
Meijuan SunDepartment of Pharmacy, Daqing Third Hospital, Daqing, Heilongjiang, China.
Ruiling ZhangDepartment of Psychiatry, Henan Mental Hospital, Xinxiang, Henan, China.
Jindong ChenDepartment of Psychiatry, and National Clinical Research Center for Mental Disorders, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
Duanfang CaiDepartment of Psychiatry, The Fifth People's Hospital of Zigong, Zigong, Sichuan, China.
Hong SangMental Health Center, Changchun Sixth Hospital, Changchun, Jilin, China.
Xianglai LiuInstitute of Mental Health, Hainan Provincial Anning Hospital, Haikou, Hainan, China.
Guilai ZhanDepartment of Psychiatry, Xuhui Mental Health Center, Shanghai, China.
Guijun ZhaoDepartment of Psychiatry, Guangyuan Mental Health Center, Guangyuan, Sichuan, China.
Haiyun LiMedical Affairs, Sumitomo Pharma (Suzhou) Co., Ltd. Shanghai, Shanghai, China.
Zhiyuan XunDepartment of Psychiatry, Tianjin Anding Hospital, Hexi District, Tianjin, 300222, China. tjad002@163.com.
Tianjin Anding Hospital · CNHunan Institute of Mental Health · CNAnhui Mental Health Center · CNBeijing Anding Hospital · CNHarbin Medical University · CNHebei Mental Health Center · CNHenan Psychiatric Hospital · CNSecond Xiangya Hospital of Central South University · CNShandong Mental Health Center · CNSixth Hospital of Changchun City · CNZigong First People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBlonanserin (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).

methodsA 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.

results364 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.

conclusionsBNS 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).

Indexed as

BlonanserinEffectivenessMedium to high dosesSafetySchizophrenia

Identifiers

PMID37803378
PMCPMC10557194
OpenAlexW4387403338

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.