Blin Patrick, Dureau-Pournin Caroline, Jové Jérémy, Lassalle Regis, Droz Cécile, Moore Nicholas
Affiliations: Bordeaux PharmacoEpi, INSERM CIC 1401, University of Bordeaux, France.
MethodsX. 2020 Jan 23;7:100796. doi: 10.1016/j.mex.2020.100796. eCollection 2020.
Users of newly marketed drugs often differ from the patients included in randomized clinical trials, and from patients prescribed similar drugs. Cohorts of such users may be compared using propensity score adjustment, or similar user cohorts may be built using high-dimensional propensity score matching in large population databases. One such database is SNDS, the French nationwide claims and hospitalization database, which covers 99 % of the French population. It has yet been rarely used. To study the comparative effectiveness and safety in secondary coronary prevention of ticagrelor, compared to clopidogrel or prasugrel, we identified in SNDS patients who were dispensed any of the three antiplatelet agents of interest (± aspirin) within a month after discharge from hospital for acute coronary syndrome (ACS) and followed them one year for recurrence of ACS, stroke, acute bleeding, or death. High-dimensional propensity scores were developed to identify matched cohorts. Drug performances were also compared in the whole population using adjustment on the same parameters. Here we describe the database that was used, and the methods developed for the high-dimensional propensity score matching, resulting in standardized mean differences between the matched populations of less than 2 % for all of the 500+ variables included in the model. ••.
新上市药物的使用者往往与随机临床试验中纳入的患者不同，也与使用类似药物的患者不同。可以使用倾向评分调整来比较此类使用者队列，或者在大型人口数据库中使用高维倾向评分匹配来构建类似的使用者队列。其中一个这样的数据库是SNDS，即法国全国性的索赔和住院数据库，覆盖了99%的法国人口。它很少被使用。为了研究替格瑞洛在冠状动脉二级预防中的有效性和安全性，并与氯吡格雷或普拉格雷进行比较，我们在SNDS中识别出因急性冠状动脉综合征（ACS）出院后一个月内使用了三种感兴趣的抗血小板药物（±阿司匹林）中的任何一种的患者，并对他们进行了一年的随访，观察ACS复发、中风、急性出血或死亡情况。通过开发高维倾向评分来识别匹配队列。还使用相同参数的调整在整个人口中比较了药物疗效。在此我们描述所使用的数据库以及为高维倾向评分匹配所开发的方法，该方法使得模型中包含的500多个变量在匹配人群之间的标准化均值差异小于2%。••.
