Real-World Usage of Sacubitril/Valsartan in Korea: A Multi-Center, Retrospective Study.

Abstract

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.