Research Division, Federal Institute for Drugs and Medical Devices, Bonn, North Rhine-Westphalia, Germany.
Techniker Krankenkasse, Hamburg, Germany.
BMJ Open. 2020 Apr 27;10(4):e032624. doi: 10.1136/bmjopen-2019-032624.
Pre-emptive testing of pharmacogenetically relevant single-nucleotide polymorphisms can be an effective tool in the prevention of adverse drug reactions and therapy resistance. However, most of the tests are not used as standard in routine care in Germany because of lacking evidence for the clinical and economical benefit and their impact on the usage of healthcare services. We address this issue by investigating the influence of pharmacogenetic profiles on the use of healthcare services over an extended period of several years using routine care data from a statutory health insurance company. The goal is to provide clinical evidence whether pre-emptive pharmacogenetic testing of metabolic profiles in routine care in Germany is beneficial and cost-effective.
The EMPAR (Einfluss metabolischer Profile auf die Arzneimitteltherapiesicherheit in der Routineversorgung) study is a non-interventional cohort study conducted to analyse pharmacogenetic risk factors that are important for drug therapy by means of endpoints relevant for healthcare. The analysis is based on pharmacogenetic profiles and statutory health insurance data. We perform pharmacogenetic, pharmacoepidemiological and pharmacoeconomic analyses using health care utilisation scores and machine learning techniques. Therefore, we aim to include about 10 000 patients (≥18 years) insured by the health insurance provider Techniker Krankenkasse. The study focuses on patients with prescriptions of anticoagulants and prescriptions of cholesterol-lowering drugs. Also, a screening for special pharmacogenetic characteristics will be performed in patients with at least one Y57.9! diagnosis (Complication of medical and surgical care: drug or medicament, unspecified). Outcomes include the utilisation of health insurance services, the incidence of incapacity for work and costs for drugs and treatment.
The protocol was approved by the Ethics Committee of the Medical Faculty, University of Bonn (Lfd. Nr. 339/17). The results of this research project will be published in scientific open access journals and at conferences.
German Clinical Trials Register, DRKS00013909.
预先检测与药物相关的单核苷酸多态性可以成为预防药物不良反应和治疗耐药性的有效工具。然而，由于缺乏临床和经济获益的证据，以及它们对医疗服务使用的影响，大多数检测并未在德国常规护理中得到应用。我们通过使用法定健康保险公司的常规护理数据，在多年的时间里研究了药物遗传学特征对医疗服务使用的影响，从而解决了这一问题。我们的目标是提供临床证据，证明在德国常规护理中预先进行代谢组学药物遗传学检测是否具有益处和成本效益。
EMPAR（Einfluss metabolischer Profile auf die Arzneimitteltherapiesicherheit in der Routineversorgung）研究是一项非干预性队列研究，旨在通过与医疗保健相关的终点来分析对药物治疗重要的药物遗传学风险因素。该分析基于药物遗传学特征和法定健康保险数据。我们使用医疗保健利用率评分和机器学习技术进行药物遗传学、药物流行病学和药物经济学分析。因此，我们的目标是纳入约 10000 名（≥18 岁）由 Techniker Krankenkasse 健康保险公司承保的患者。该研究主要关注抗凝药物和降胆固醇药物处方的患者。此外，还将对至少有一个 Y57.9！诊断（医疗和外科护理的并发症：药物，未特指）的患者进行特殊药物遗传学特征筛查。结果包括医疗保险服务的利用、丧失工作能力的发生率以及药物和治疗的费用。
该方案已获得波恩大学医学系伦理委员会的批准（编号：339/17）。该研究项目的结果将发表在科学开放获取期刊和会议上。
德国临床试验注册处，DRKS00013909。
