Jaewon Oh1, Chan Joo Lee1, Jin Joo Park2, Sang Eun Lee3, Min-Seok Kim3, Hyun-Jai Cho4, Jin-Oh Choi5, Hae-Young Lee4, Kyung-Kuk Hwang6, Kye Hun Kim7, Byung-Su Yoo8, Dong-Ju Choi2, Sang Hong Baek9, Eun-Seok Jeon5, Jae-Joong Kim3, Myeong-Chan Cho6, Shung Chull Chae10, Byung-Hee Oh11, Seok-Min Kang1. 1. Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Korea. 2. Division of Cardiology, Seoul National University Bundang Hospital, Seongnam, Korea. 3. Division of Cardiology, Asan Medical Center, Seoul, Korea. 4. Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. 5. Department of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea. 6. Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea. 7. Department of Internal Medicine, Chonnam National University, Gwangju, Korea. 8. Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea. 9. Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea. 10. Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea. 11. Department of Internal Medicine, Mediplex Sejong Hospital, Incheon, Korea.
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.
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.
Authors: Craig Balmforth; Joanne Simpson; Li Shen; Pardeep S Jhund; Martin Lefkowitz; Adel R Rizkala; Jean L Rouleau; Victor Shi; Scott D Solomon; Karl Swedberg; Michael R Zile; Milton Packer; John J V McMurray Journal: JACC Heart Fail Date: 2019-05-08 Impact factor: 12.035
Authors: John J V McMurray; Milton Packer; Akshay S Desai; Jianjian Gong; Martin P Lefkowitz; Adel R Rizkala; Jean L Rouleau; Victor C Shi; Scott D Solomon; Karl Swedberg; Michael R Zile Journal: N Engl J Med Date: 2014-08-30 Impact factor: 91.245
Authors: Andrew P Ambrosy; Gregg C Fonarow; Javed Butler; Ovidiu Chioncel; Stephen J Greene; Muthiah Vaduganathan; Savina Nodari; Carolyn S P Lam; Naoki Sato; Ami N Shah; Mihai Gheorghiade Journal: J Am Coll Cardiol Date: 2014-02-05 Impact factor: 24.094