|
KMID : 1812720190010010057
|
|
International Journal of Heart Failure
2019 Volume.1 No. 1 p.57 ~ p.68
|
|
|
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
|
|
Oh Jae-Won
Lee Chan-Joo
Park Jin-Joo
Lee Sang-Eun
Kim Min-Seok
Cho Hyun-Jai
Choi Jin-Oh
Lee Hae-Young
Hwang Kyung-Kuk
Kim Kye-Hun
Yoo Byung-Su
Choi Dong-Ju
Baek Sang-Hong
Jeon Eun-Seok
Kim Jae-Joong
Cho Myeong-Chan
Chae Shung-Chull
Oh Byung-Hee
Kang Seok-Min
|
|
|
Abstract
|
|
|
Background and Objectives: 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 prescription 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.
Methods: 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 mg enalapril (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.
|
|
|
KEYWORD
|
|
|
Sacubitril-valsartan, Heart failure, Drung therapy, Patient care
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|