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논문 기본 정보

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저자정보
Kim Eui-Soon (Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.) Park Sun-Kyeong (College of Pharmacy, The Catholic University of Korea, Bucheon, Korea.) Youn Jong-Chan (Division of Cardiology, Department of Internal Medicine, Seoul St. Mary’s Hospital, Catholic Research Institute for Intractable Cardiovascular Disease, College of Medicine, The Catholic Univ) Lee Hye Sun (Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Korea.) Lee Hae-Young (Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.Seoul National University School of Medicine, Seoul, Korea.) Cho Hyun-Jai (Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.Seoul National University School of Medicine, Seoul, Korea.) Choi Jin-Oh (Department of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea.) Jeon Eun-Seok (Department of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea.) Lee Sang Eun (Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.) Kim Min-Seok (Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.) Kim Jae-Joong (Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.) Hwang Kyung-Kuk (Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.) Cho Myeong-Chan (Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.) Chae Shung Chull (Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea.) Kang Seok-Min (Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.) Park Jin Joo (Seoul National University School of Medicine, Seoul, Korea.Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.) Choi Dong-Ju (Seoul National University School of Medicine, Seoul, Korea.Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.) Yoo Byung-Su (Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.) Cho Jae Yeong (Department of Cardiovascular Medicine, Chonnam National University Medical School, Gwangju, Korea.) Kim Kye Hun (Department of Cardiovascular Medicine, Chonnam National University Medical School, Gwangju, Korea.) Oh Byung-Hee (Department of Cardiovascular medicine, Incheon Sejong Hospital, Incheon, Korea.) Greenberg Barry (Department of Cardiology, UC San Diego Health System, La Jolla, CA, USA.) Baek Sang Hong (Division of Cardiology, Department of Internal Medicine, Seoul St. Mary’s Hospital, Catholic Research Institute for Intractable Cardiovascular Disease, College of Medicine, The Catholic Univ)
저널정보
대한의학회 Journal of Korean Medical Science Journal of Korean Medical Science Vol.39 No.1
발행연도
2024.1
수록면
1 - 15 (15page)
DOI
10.3346/jkms.2024.39.e8

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초록· 키워드

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Background: The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved empagliflozin for reducing cardiovascular mortality and heart failure (HF) hospitalization in patients with both HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). However, limited data are available on the generalizability of empagliflozin to clinical practice. Therefore, we evaluated real-world eligibility and potential cost-effectiveness based on a nationwide prospective HF registry. Methods: A total of 3,108 HFrEF and 2,070 HFpEF patients from the Korean Acute Heart Failure (KorAHF) registry were analyzed. Eligibility was estimated by inclusion and exclusion criteria of EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced) and EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) trials and by FDA & EMA label criteria. The cost-utility analysis was done using a Markov model to project the lifetime medical cost and quality-adjusted life year (QALY). Results: Among the KorAHF patients, 91.4% met FDA & EMA label criteria, while 44.7% met the clinical trial criteria. The incremental cost-effectiveness ratio of empagliflozin was calculated at US$6,764 per QALY in the overall population, which is far below a threshold of US$18,182 per QALY. The cost-effectiveness benefit was more evident in patients with HFrEF (US$5,012 per QALY) than HFpEF (US$8,971 per QALY). Conclusion: There is a large discrepancy in real-world eligibility for empagliflozin between FDA & EMA labels and clinical trial criteria. Empagliflozin is cost-effective in HF patients regardless of ejection fraction in South Korea health care setting. The efficacy and safety of empagliflozin in real-world HF patients should be further investigated for a broader range of clinical applications.
#SGLT2 Inhibitors #Empagliflozin #Heart Failure #Drug Therapy #Cost-Effectiveness Analysis

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