在德国开展的一项全国性纵向队列研究:维立西呱治疗患者的真实世界特征和使用模式。
Real-world characteristics and use patterns of patients treated with vericiguat: A nationwide longitudinal cohort study in Germany.
机构信息
Department of Clinical Research and Epidemiology, Comprehensive Heart Failure Center, University Hospital Würzburg, D-97080, Würzburg, Germany.
Department of Internal Medicine I, University Hospital Würzburg, D-97080, Würzburg, Germany.
出版信息
Eur J Clin Pharmacol. 2024 Jun;80(6):931-940. doi: 10.1007/s00228-024-03654-0. Epub 2024 Mar 12.
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.
目的
在临床试验中,维立西呱可降低心力衰竭恶化患者的临床终点,但在临床试验之外的应用情况尚不清楚。
方法
本回顾性分析基于 IQVIA™ LRx 数据库,该数据库包含德国法定健康保险覆盖的约 7300 万人中的约 80%的处方。
结果
在 2021 年 9 月至 2022 年 12 月期间,2916 名成年患者开始使用维立西呱。他们的平均年龄为 73±13 岁,28%为女性。虽然大约 70%的患者从 2.5mg 上调剂量至 2.5mg 以上,但只有 36%的患者达到 10mg。从 2.5mg 上调至 5mg 的中位时间为 17 天(四分位间距:11-33),从 2.5mg 上调至 10mg 的中位时间为 37 天(25-64)。在 87%的患者中,维立西呱的用药依从性较高,表现为药物使用量比例≥80%,67%的患者在第一年持续使用维立西呱。女性和老年患者较少达到维立西呱的最大剂量 10mg,较少使用指南推荐的治疗药物(GDMT)的其他类别。开始使用维立西呱后,接受 GDMT 四个支柱的患者比例从 29%增加到 44%。
结论
在真实世界环境中,尽管患者年龄高于临床试验,但各年龄段的维立西呱的依从性和持久性均令人满意。开始使用维立西呱与同时使用 GDMT 的强化相关。然而,需要进一步调查维立西呱上调剂量和实施其他 GDMT 的障碍,这些障碍尤其适用于女性和老年患者。