Steenhuis Dennis, Li Xuechun, Feenstra Talitha L, Hak Eelko
Groningen Research Institute of Pharmacy, Unit of Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, the Netherlands.
Clin Epidemiol. 2025 Mar 28;17:327-336. doi: 10.2147/CLEP.S508754. eCollection 2025.
To date, complete and long-term registrations of diseases and events are not available in every situation. As a useful proxy, medication usage data is very promising. For instance, real-world dispensing data from pharmacies are attractive because of the high validity of drug dispensing data, large sample sizes, and long-term registration. However, before application as a proxy, validity must be assessed. Therefore, in this study, we aim to assess the validity of various medicines used as a proxy for major adverse cardio-cerebrovascular events (MACCE), that is, to identify an incident or previous hospitalization for a MACCE.
Using the claims database of a large Dutch healthcare insurer, we estimated the concordance between hospitalization claims for MACCE and specific claims for dispensings to treat MACCE in a cohort of patients on primary preventive antihypertensive and/or antihyperlipidemic therapy between 2013 and 2020.
In a cohort of more than 110,000 patients, a dispensing of either vitamin K antagonists, platelet aggregation inhibitors, or nitrates was predictive of an incident hospitalization for a MACCE between 2013 and 2020, with a sensitivity of 71.5% (95% CI: 70.4-72.5%) and specificity of 93.2% (95% CI 91.1-93.4%), and any history of hospitalization for a MACCE (prevalence) with a sensitivity of 86.9% (95% CI: 86.5-87.3%) and specificity of 81.9 (956% CI: 81.6-82.1%), while positive predicted value remains low. Sensitivity analyses across age, sex, and patients with asthma/COPD or diabetes showed a similarly good performance.
Claims for the dispensings of vitamin K antagonists, platelet aggregation inhibitors, and/or nitrates can be validly used as a proxy for new and previous hospitalization for MACCE in patients on primary preventive therapy. Further study is required to assess the validity of such dispensing claims for non-hospitalized cerebro-cardiovascular events and whether the results are generalizable in non-Dutch cohorts.
到目前为止，并非在所有情况下都能获得完整且长期的疾病和事件登记信息。作为一种有用的替代指标，药物使用数据很有前景。例如，来自药房的真实世界配药数据很有吸引力，因为药物配药数据的有效性高、样本量大且能长期登记。然而，在作为替代指标应用之前，必须评估其有效性。因此，在本研究中，我们旨在评估用作主要不良心脑血管事件（MACCE）替代指标的各种药物的有效性，即识别MACCE的新发事件或既往住院情况。
利用一家大型荷兰医疗保险公司的理赔数据库，我们估计了在2013年至2020年期间接受原发性预防性抗高血压和/或抗高血脂治疗的患者队列中，MACCE住院理赔与治疗MACCE的特定配药理赔之间的一致性。
在超过110,000名患者的队列中，2013年至2020年期间，使用维生素K拮抗剂、血小板聚集抑制剂或硝酸盐进行配药可预测MACCE的新发住院情况，敏感性为71.5%（95%置信区间：70.4 - 72.5%），特异性为93.2%（95%置信区间91.1 - 93.4%），以及MACCE的任何既往住院史（患病率），敏感性为86.9%（95%置信区间：86.5 - 87.3%），特异性为81.9（95%置信区间：81.6 - 82.1%），而阳性预测值仍然较低。在年龄、性别以及患有哮喘/慢性阻塞性肺疾病或糖尿病的患者中进行的敏感性分析显示出类似的良好表现。
维生素K拮抗剂、血小板聚集抑制剂和/或硝酸盐的配药理赔可有效地用作原发性预防性治疗患者MACCE新发和既往住院情况的替代指标。需要进一步研究来评估此类配药理赔对于非住院心脑血管事件的有效性，以及结果是否可推广至非荷兰队列。
