接受阿立哌唑每月一次治疗的患者中抗胆碱能药物的使用频率：一项使用欧洲医疗数据库的为期2年的队列研究。
Frequency of anticholinergic drug use in patients treated with aripiprazole once-monthly: a 2-year cohort study using European healthcare databases.
作者信息
Andersohn Frank, Such Pedro, Jan Michael, Kalu Uwa, McDonough Jessica, Reinold Jonas, Riedel Oliver, Trifirò Gianluca, Ientile Valentina, Tari Michele, Pastorello Maurizio, Arana Alejandro, Forns Joan, Hakkarainen Katja M, Nunez Leyla, Jørgensen Kristian Tore, Simonsen Jacob, Yildirim Murat
机构信息
Frank Andersohn Consulting & Research Services, Mandelstr 16, Berlin 10409, Germany.
H. Lundbeck A/S, Valby, Denmark.
出版信息
Ther Adv Psychopharmacol. 2025 Aug 30;15:20451253251368010. doi: 10.1177/20451253251368010. eCollection 2025.
BACKGROUND
Extrapyramidal symptoms (EPS) in association with the long-acting, injectable, atypical antipsychotic aripiprazole once monthly (AOM) have been observed in clinical trials, but information on EPS requiring treatment with anticholinergic drugs in clinical practice is limited.
OBJECTIVES
The objective of this European post-authorisation safety study (PASS) was to assess the risk of EPS-related events, as defined by dispensings of anticholinergic drugs, linked to the use of AOM in routine clinical practice.
DESIGN
This European cohort study was based on healthcare databases from Germany (German Pharmacoepidemiological Research Database GePaRD), Italy (Caserta and Palermo healthcare claims databases), and Sweden (National health registers). New users of AOM were followed from their first dispensing for a maximum of 2 years.
METHODS
Primary study outcome was an EPS-related event, defined as the first dispensing of an anticholinergic drug. The crude incidence rate (IR) and the cumulative incidence of EPS-related events were estimated. Cox proportional hazard regression modelling was performed to further investigate the effect of potential risk factors for the occurrence of EPS-related events.
RESULTS
A total of = 1748 patients were eligible for inclusion into the primary study populations (Germany = 629; Italy = 519; Sweden = 600). IRs of EPS-related events per 100 patient years were highest in Italy (IR = 18.4; 95% confidence interval (CI) 15.3-22.1), followed by Sweden (IR = 7.7; 95% CI 5.8-10.2) and Germany (IR = 3.4; 95% CI 2.4-4.6). Rates were highest during the first 30 days after treatment initiation. Cumulative incidences after 2 years of treatment were 27.8% (Italy), 11.5% (Sweden), and 10.0% (Germany). Diabetes and previous antipsychotic drug use were identified as risk factors for EPS-related events.
CONCLUSION
In this observational study, incidence rates of EPS-related events, defined as the first dispensing of an anticholinergic drug during follow-up, were compatible with the known safety profile of AOM but showed substantial regional variation.
TRIAL REGISTRATION
EU PAS number EUPAS21056.
背景
在临床试验中已观察到长效注射用非典型抗精神病药物阿立哌唑每月一次（AOM）会引发锥体外系症状（EPS），但关于临床实践中需要使用抗胆碱能药物治疗的EPS的信息有限。
目的
这项欧洲上市后安全性研究（PASS）的目的是评估在常规临床实践中，与使用AOM相关的、由抗胆碱能药物配药定义的EPS相关事件的风险。
设计
这项欧洲队列研究基于德国（德国药物流行病学研究数据库GePaRD）、意大利（卡塞塔和巴勒莫医疗保健索赔数据库）和瑞典（国家健康登记册）的医疗保健数据库。AOM的新使用者从首次配药开始随访，最长随访2年。
方法
主要研究结局是EPS相关事件，定义为首次配药使用抗胆碱能药物。估计了EPS相关事件的粗发病率（IR）和累积发病率。进行Cox比例风险回归建模以进一步研究EPS相关事件发生的潜在风险因素的影响。
结果
共有1748名患者符合纳入主要研究人群的条件（德国629名；意大利519名；瑞典600名）。每100患者年的EPS相关事件IR在意大利最高（IR = 18.4；95%置信区间（CI）15.3 - 22.1），其次是瑞典（IR = 7.7；95% CI 5.8 - 10.2）和德国（IR = 3.4；95% CI 2.4 - 4.6）。治疗开始后的前30天发生率最高。治疗2年后的累积发病率分别为27.8%（意大利）、11.5%（瑞典）和10.0%（德国）。糖尿病和既往使用抗精神病药物被确定为EPS相关事件的风险因素。
结论
在这项观察性研究中，定义为随访期间首次配药使用抗胆碱能药物的EPS相关事件的发病率与AOM已知的安全性特征相符，但存在显著的地区差异。
试验注册
欧盟PAS编号EUPAS21056。
Zotero 插件