韩国Sacubitril/缬沙坦的实际使用:一项多中心回顾性研究。

International Journal of Heart Failure Pub Date : 2022-10-25 eCollection Date: 2022-10-01 DOI:10.36628/ijhf.2022.0015
Jin Joo Park, Sang-Eun Lee, Hyun-Jai Cho, Jin-Oh Choi, Byung-Su Yoo, Seok-Min Kang, Hsiang-Chi Wang, Sue Lee, Dong-Ju Choi
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引用次数: 7

摘要

背景与目的:临床试验与现实世界实践之间存在药物处方差异。我们评估了韩国心力衰竭(HF)患者使用苏比里尔/缬沙坦的实际治疗模式。方法:在这项回顾性、多中心队列研究中,600例伴有左室射血分数降低的HF患者(LVEF)。结果:基线时,59.2%、28.3%、4.8%和7.7%的患者分别接受低剂量(bid 50 mg)、中剂量(bid 100 mg)、靶剂量(bid 200 mg)和非常规剂量的苏比利缬沙坦治疗。低剂量和中等剂量的患者要么“无滴定”(39.8%),要么“稳定的上升滴定”(41.5%)。在12个月时,分别有31.7%、28.5%、24.8%和15%的患者接受了低剂量、中等剂量、目标剂量和非常规剂量。在随访中,31例(5.2%)患者停用苏比里尔/缬沙坦。时间平均n端前b型利钠肽(NT-proBNP)水平从879.6降至406 pg/mL(比值,0.5;95%置信区间为0.4-0.5)。平均LVEF从27.2±5.8增加到36.3±11.1%,增加了10.4±12.2%,而左室舒张末期容积指数分别从基线和随访时的114.5±37.7 mL/m2下降到98.9±42.3 mL/m2,下降了18.7±26.1 mL/m2。结论:在现实世界的实践中,95%的患者开始使用低剂量和中等剂量的苏比里尔/缬沙坦。许多患者在随访期间出现剂量上升;30%达到了目标剂量。心脏反向重构反映在NT-proBNP水平和左室大小的显著降低以及LVEF的增加。这项研究证实了临床试验和现实世界实践之间治疗模式的差距。
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Real-World Usage of Sacubitril/Valsartan in Korea: A Multi-Center, Retrospective Study.

Background and objectives: Differences in drug prescriptions exist between clinical trials and real-world practice. We evaluated the real-world treatment patterns of sacubitril/valsartan in Korean patients with heart failure (HF).

Methods: In this retrospective, multicenter cohort study, 600 patients with HF with reduced left-ventricular ejection fraction (LVEF <40%) with ≥1 sacubitril/valsartan prescription were identified by reviewing patient-level medical records at six academic tertiary hospitals in Korea between February 2017 and April 2019.

Results: At baseline, 59.2%, 28.3%, 4.8%, and 7.7% of the patients received low (50 mg bid), moderate (100 mg bid), target (200 mg bid), and unconventional dose of sacubitril/valsartan, respectively. Patients with low and moderate doses experienced either 'no-titration' (39.8%) or 'stable up-titration' (41.5%). At 12 months, 31.7%, 28.5%, 24.8%, and 15% received low, moderate, target doses, and unconventional dose, respectively. On follow-up, 31 (5.2%) patients discontinued sacubitril/valsartan. The time-averaged N-terminal pro-B-type natriuretic peptide (NT-proBNP) level decreased from 879.6 to 406 pg/mL (ratio, 0.5; 95% confidence interval, 0.4-0.5). The mean LVEF increased by 10.4±12.2% from 27.2±5.8 to 36.3±11.1%, whereas LV end-diastolic volume index decreased by 18.7±26.1 mL/m2 from 114.5±37.7 mL/m2 to 98.9±42.3 mL/m2 at baseline and follow-up, respectively.

Conclusions: In real-world practice, 95% patients started with low and moderate doses of sacubitril/valsartan. Many patients experienced dose up-titration during follow-up; 30% reached the target dose. Cardiac reverse remodelling was reflected by a profound NT-proBNP level and LV size reduction, and LVEF increment. This study confirms the gap in treatment patterns between clinical trials and real-world practice.

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