Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Kirrberger Str. 1, 66421, Homburg/Saar, Germany.
Deutsches Arzneiprüfungsinstitut e. V. (DAPI), Heidestr. 7, 10557, Berlin, Germany.
Clin Res Cardiol. 2023 Feb;112(2):197-202. doi: 10.1007/s00392-022-01993-5. Epub 2022 Feb 27.
The 2018 European Society of Cardiology (ESC)/European Society of Hypertension (ESH) guidelines for the management of hypertension highlight the importance of fixed-dose combinations (FDC) for the treatment of hypertension and recommend initial single-pill combination therapy in almost all patients. However, data on the implementation of these recommendations in clinical practice are scarce.
Data from the German Institute for Drug Use Evaluation (DAPI) were analyzed and extrapolated accounting for approximately 88% of Germany's population (approximately 73.3 million subjects). All antihypertensive (AHT) FDC products available on the German market were included in the analyses. We examined the time course of dispensed packages between January 2016 and December 2020.
FDCs accounted for 15.4% of all AHT in 2016 and for 10.9% in 2020. While dispensing of all AHT increased slightly from year to year (2016: 143.8 million, 2020: 153.2 million packs), dispensing of FDCs decreased from 22.2 million (2016) to 16.6 million (2020) packs. Dispensing of FDCs containing hydrochlorothiazide (HCT) declined considerably from 2016 to 2020 (Q1 2016: 4.65 million, Q4 2020: 3.13 million packs). Accordingly, the proportion of HCT-containing combinations in all FDCs decreased from 85.3 to 74.2% from Q1 2016 to Q4 2020. Patients younger than 80 years were prescribed FDCs more frequently (14.6% of all AHT, based on the entire evaluation period) than patients 80 years and older (10.0%). In both age groups, this proportion decreased continuously over time.
Almost 2 years following the release of the 2018 ESC/ESH guidelines, only 10.9% of the prescribed packs of antihypertensive drugs in 2020 were FDC products, documenting underutilization of current guideline recommendations on pharmacotherapy in hypertension. Structured programs to evidence-based decision support are required to improve guideline inertia and patient outcomes, eventually.
2018 年欧洲心脏病学会(ESC)/欧洲高血压学会(ESH)高血压管理指南强调了固定剂量复方制剂(FDC)在高血压治疗中的重要性,并建议几乎所有患者初始采用单药联合治疗。然而,关于这些建议在临床实践中的实施数据仍然有限。
对德国药物利用研究所(DAPI)的数据进行了分析和推断,这些数据涵盖了德国约 88%的人口(约 7330 万受试者)。分析中纳入了所有在德国市场上可获得的抗高血压(AHT)FDC 产品。我们检查了 2016 年 1 月至 2020 年 12 月期间分发的包装数量随时间的变化情况。
2016 年,FDC 占所有 AHT 的 15.4%,2020 年占 10.9%。虽然每年 AHT 的分发量略有增加(2016 年:1.438 亿包,2020 年:1.532 亿包),但 FDC 的分发量从 2016 年的 2220 万包减少到 2020 年的 1660 万包。含氢氯噻嗪(HCT)的 FDC 分发量从 2016 年到 2020 年(2016 年第一季度:465 万包,2020 年第四季度:313 万包)大幅下降。相应地,2016 年第一季度至 2020 年第四季度,HCT 含量组合在所有 FDC 中的比例从 85.3%降至 74.2%。年龄小于 80 岁的患者比 80 岁及以上的患者更频繁地开处方 FDC(基于整个评估期,占所有 AHT 的 14.6%)。在这两个年龄组中,这一比例随着时间的推移持续下降。
在 2018 年 ESC/ESH 指南发布近 2 年后,2020 年处方的抗高血压药物中只有 10.9%是 FDC 产品,这表明当前高血压药物治疗指南建议的应用不足。需要制定基于证据的决策支持结构化方案,以最终改善指南惯性和患者预后。