Klinik Für Psychiatrie Und Psychotherapie, Zentrum Für Psychosoziale Medizin, Universitätsklinikum Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
Lundbeck GmbH, Ericusspitze 2, 20457, Hamburg, Germany.
BMC Psychiatry. 2023 Mar 14;23(1):162. doi: 10.1186/s12888-023-04651-w.
Patients with schizophrenia may benefit from treatment with long-acting injectable (LAI) formulations of antipsychotics. Aripiprazole once-monthly (AOM) is an LAI that was tested in two non-interventional studies in Germany and Canada.
Here, we report on analyses of pooled data from the two non-interventional studies. Patients were treated with AOM under real-life conditions. Data were analyzed for a timeframe of 6 months. We analyzed data on Brief Psychiatric Rating Scale (BPRS) domains and items, BPRS total scores in various patient subgroups (male vs. female patients, patients with disease duration ≤ 5 years and > 5 years, patients with different levels of disease severity at baseline), Clinical Global Impression - Improvement (CGI-I) ratings for the total population and subgroups, and comorbidities for the total population.
Data from 409 patients were included. 65.5% of the patients had comorbidities. Improvements were found in all BPRS domains and items. Furthermore, improvements were similar for male and female patients, patients with disease duration ≤ 5 years and > 5 years, and across different levels of disease severity at baseline. Numerically, more favorable results were found for younger patients, female patients, and those with shorter disease duration.
AOM can be an effective treatment in the broad range of patients, across sexes, regardless of patient age and duration of disease, independently of disease severity, and across symptoms.
NCT02131415 (May 6, 2014), vfa non-interventional studies registry 15960N.
精神分裂症患者可能受益于长效注射(LAI)抗精神病药物的治疗。阿立哌唑每月 1 次(AOM)是一种 LAI,已在德国和加拿大的两项非干预性研究中进行了测试。
在此,我们报告了两项非干预性研究的汇总数据分析结果。患者在真实环境下接受 AOM 治疗。分析了 6 个月的时间框架内的数据。我们分析了简明精神病评定量表(BPRS)各领域和项目、不同患者亚组(男性与女性患者、疾病持续时间≤5 年与>5 年患者、基线时不同严重程度的患者)的 BPRS 总分、总人群和亚组的临床总体印象-改善(CGI-I)评分,以及总人群的合并症。
共纳入 409 例患者。65.5%的患者存在合并症。所有 BPRS 领域和项目均有改善。此外,男性和女性患者、疾病持续时间≤5 年与>5 年患者、基线时不同严重程度的患者之间的改善情况相似。在数值上,年轻患者、女性患者和疾病持续时间较短的患者结果更为有利。
AOM 可作为一种有效治疗方案,适用于广泛的患者,无论性别、年龄和疾病持续时间,以及疾病严重程度和症状如何。
NCT02131415(2014 年 5 月 6 日),vfa 非干预性研究注册 15960N。