Real-world characteristics and use patterns of patients treated with vericiguat: A nationwide longitudinal cohort study in Germany.

IF 2.4 3区 医学 Q3 PHARMACOLOGY & PHARMACY European Journal of Clinical Pharmacology Pub Date : 2024-06-01 Epub Date: 2024-03-12 DOI:10.1007/s00228-024-03654-0
Fabian Kerwagen, Christoph Ohlmeier, Thomas Evers, Stefan Herrmann, Inga Bayh, Alexander Michel, Silvia Kruppert, Joanna Wilfer, Rolf Wachter, Michael Böhm, Stefan Störk
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Abstract

Purpose: Vericiguat reduced clinical endpoints in patients experiencing worsening heart failure in clinical trials, but its implementation outside trials is unclear.

Methods: This retrospective analysis of longitudinally collected data was based on the IQVIA™ LRx database, which includes ~ 80% of the prescriptions of the 73 million people covered by the German statutory health insurance.

Results: Between September 2021 and December 2022, vericiguat was initiated in 2916 adult patients. Their mean age was 73 ± 13 years and 28% were women. While approximately 70% were uptitrated beyond 2.5 mg, only 36% reached 10 mg. Median time to up-titration from 2.5 mg to 5 mg was 17 (quartiles: 11-33) days, and from 2.5 to 10 mg 37 (25-64) days, respectively. In 87% of the patients, adherence to vericiguat was high as indicated by a medication possession ratio of  ≥ 80%, and 67% of the patients persistently used vericiguat during the first year. Women and older patients reached the maximal dose of 10 mg vericiguat less often and received other substance classes of guideline-recommended therapy (GDMT) less frequently. The proportion of patients receiving four pillars of GDMT increased from 29% before vericiguat initiation to 44% afterwards.

Conclusion: In a real-world setting, despite higher age than in clinical trials, adherence and persistence of vericiguat appeared satisfactory across age categories. Initiation of vericiguat was associated with intensification of concomitant GDMT. Nevertheless, barriers to vericiguat up-titration and implementation of other GDMT, applying in particular to women and elderly patients, need to be investigated further.

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韦立克治疗患者的实际特征和使用模式:德国一项全国性纵向队列研究。
目的:在临床试验中,韦立克可降低心力衰竭恶化患者的临床终点,但其在试验外的实施情况尚不清楚:这项纵向数据回顾性分析基于 IQVIA™ LRx 数据库,该数据库包括德国法定医疗保险所覆盖的 7,300 万人中约 80% 的处方:结果:2021 年 9 月至 2022 年 12 月期间,2,916 名成年患者开始使用韦立克。他们的平均年龄为 73 ± 13 岁,28% 为女性。约 70% 的患者将剂量提升至 2.5 毫克以上,但只有 36% 的患者将剂量提升至 10 毫克。从 2.5 毫克升至 5 毫克的中位时间分别为 17 天(四分位数:11-33),从 2.5 毫克升至 10 毫克的中位时间分别为 37 天(25-64)。87%的患者对韦立奎特的依从性很高,持药率≥80%,67%的患者在第一年内坚持使用韦立奎特。女性和年龄较大的患者达到 10 毫克韦立克最大剂量的频率较低,接受指南推荐疗法(GDMT)中其他药物类别的频率也较低。接受GDMT四大支柱治疗的患者比例从开始服用韦立克加特前的29%增加到开始服用后的44%:在现实世界中,尽管年龄高于临床试验,但各年龄段患者对韦立吉曲的依从性和持续性似乎都令人满意。开始服用维力古特与同时加强 GDMT 有关。尽管如此,仍需进一步研究韦立克加量和实施其他 GDMT 的障碍,尤其是女性和老年患者的障碍。
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5.40
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3.40%
发文量
170
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3-8 weeks
期刊介绍: The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.
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