International Journal of Heart Failure, 2019. 1(1), 57-68, DOI: https://doi.org/10.36628/ijhf.2019.0007

org/10.36628/ijhf.2019.0007

Real-World Eligibility for Sacubitril/Valsartan in Heart Failure with Reduced Ejection Fraction Patients in Korea: Data from the Korean Acute Heart Failure (KorAHF) Registry

Jaewon Oh, Chan Joo Lee; Jin Joo Park; Sang Eun Lee; Min-Seok Kim; Hyun-Jai Cho; Jin-Oh Choi; Hae-Young Lee; Kyung-Kuk Hwang; Kye Hun Kim; Byung-Su Yoo; Dong-Ju Choi; Sang Hong Baek; Eun-Seok Jeon; Jae-Joong Kim; Myeong-Chan Cho; Shung Chull Chae; Byung-Hee Oh; Seok-Min Kang

Abstract

Sacubitril/valsartan (SV, LCZ696), the first in class drug, called as angiotensin receptor-neprilysin inhibitor (ARNI) can reduce heart failure (HF) hospitalization and cardiovascular mortality. However, SV preion rate remains still low despite current HF guideline recommendations. Considering the complex inclusion criteria of Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial, the real-world eligibility for SV remains uncertain in Asian heart failure with reduced ejection fraction (HFrEF) patients. Therefore, we aimed to assess real-world HF population eligibility for SV in a large Korean acute HF registry.

From March 2011 to February 2014, a total of 5,625 patients who were admitted for HF were enrolled in Korea. After excluding HF patients with left ventricular ejection fraction >40% and in-hospital death, 2,941 patients were analyzed. Criteria for SV based on Korean Food and Drug Administration (KFDA) label and PARADIGM-HF were applied.Results: Of 2,941 patients, KFDA label criteria excludes the absence of symptoms (New York Heart Association class I, 20%); PARADIGM-HF criteria excludes chronic kidney disease stage IV (9%), hyperkalemia (1%), hypotension (6%), and sub-optimal pharmacotherapy (52%, e.g. lower dose use of angiotensin converting enzyme inhibitor/angiotensin receptor blocker [ACEI/ARB], beta blocker use). When a daily requirement of ACEI/ARB ≥5 mgenalapril (instead of ≥10 mg) was used, the percent of eligibility for SV rose from 12% to 30% based on the PARADIGM-HF criteria.Conclusions: Among the Korean hospitalized HFrEF patients, 80% met KFDA label criteria, while only 12% met the inclusion criteria of PARADIGM-HF trial for SV if requiring ≥10 mg enalapril. Sub-optimal pharmacotherapy could be the main reason for ineligible SV use based on the PARADIGM-HF criteria.

• DOI: https://doi.org/10.36628/ijhf.2019.0007
• ISBN or ISSN: 2636-154X

• 본 연구는 질병관리본부 연구개발과제연구비를 지원받아 수행되었습니다.
• This research was supported by a fund by Research of Korea Centers for Disease Control and Prevention.