Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy
Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy
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DOI：
10.1007/s40264-019-00860-z
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发表时间：
2019-12-01
期刊：
影响因子：
4.2
通讯作者：
Trifiro, Gianluca
中科院分区：
文献类型：
--
作者：
Sultana, Janet;Fontana, Andrea;Trifiro, Gianluca
在英国和意大利，发布了与抗精神病药物相关的老年人中风相关的安全警告。然而，这些安全警告对中风风险的影响迄今尚未得到衡量。目的本研究的目的是测量英国和意大利两次安全警告后卒中发病率的变化。方法：使用代表英国（健康改善网络）和意大利（健康搜索-IQVIA健康LPD）的电子病历进行队列研究，分别包含1100万和100万患者的数据。在每次药物安全警告后，老年抗精神病药物新启动者在任何安全警告前与抗精神病药物启动者的倾向评分匹配为1：1：1。使用意向治疗方法，抗精神病药物治疗开始后6个月内的卒中发生率是主要结局。结果在英国和意大利，分别有6342和7587名老年抗精神病药物的使用者。首次安全警告后，英国的卒中发生率降低了42%[42.3（95%置信区间（CI）35.2-50.8）vs. 24.4 [95% CI 19.0-31.2]起事件/1000人-年（PY）]，与首次警告前相比，第二次警告后卒中发生率降低了60%（16.9 [95%CI 12.2-23.4]起事件/1000 PY）。意大利的中风发病率没有显着下降。结论：在英国，抗精神病药物安全警告后，老年抗精神病药物使用者的卒中发生率降低，但在意大利则不然。
Introduction Safety warnings relating to antipsychotic-associated stroke among older persons in the UK and Italy were issued. However, the impact of these safety warnings on stroke risk has not been measured to date. Objective The aim of this study was to measure the change in stroke incidence after two safety warnings in both the UK and Italy. Method A cohort study was conducted using electronic medical records representative of the UK (The Health Improvement Network) and Italy (Health Search-IQVIA Health LPD), containing data on 11 million and 1 million patients, respectively. After each drug safety warning, elderly antipsychotic new initiators were propensity-score matched 1:1:1 on antipsychotic initiators before any safety warning. Stroke incidence within 6 months of antipsychotic initiation, using an intention-to-treat approach, was the main outcome. Results In the UK and Italy, 6342 and 7587 elderly antipsychotic initiators were identified, respectively. A 42% stroke incidence reduction was seen in the UK after the first safety warning [42.3 (95% confidence interval (CI) 35.2-50.8) vs. 24.4 [95% CI 19.0-31.2] events per 1000 person-years (PYs)], while there was a 60% stroke incidence reduction after the second warning (16.9 [95% CI 12.2-23.4] events per 1000 PYs) compared to before the first warning. There was no significant reduction in stroke incidence in Italy. Conclusion Antipsychotic safety warnings were followed by a reduction in stroke incidence among older antipsychotic users in the UK, but not Italy.