Yevgeniy Khariton1, Gregg C Fonarow2, Suzanne V Arnold3, Ann Hellkamp4, Michael E Nassif5, Puza P Sharma6, Javed Butler7, Laine Thomas4, Carol I Duffy6, Adam D DeVore8, Nancy M Albert9, J Herbert Patterson10, Fredonia B Williams11, Kevin McCague6, John A Spertus3. 1. Departments of Cardiology and Cardiovascular Outcomes Research, Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City, Kansas City, Missouri. Electronic address: kharitony@umkc.edu. 2. Department of Cardiology, Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan University of California Los Angeles Medical Center, Los Angeles, California. 3. Departments of Cardiology and Cardiovascular Outcomes Research, Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City, Kansas City, Missouri. 4. Duke Clinical Research Institute, Durham, North Carolina. 5. Department of Cardiology, Washington University School of Medicine in Saint Louis, Saint Louis, Missouri. 6. Novartis Pharmaceuticals Corp, East Hanover, New Jersey. 7. Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi. 8. Division of Cardiology, Department of Medicine, and the Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. 9. Cleveland Clinic, Cleveland, Ohio. 10. Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina. 11. Mended Hearts, Huntsville, Alabama.
Abstract
OBJECTIVES: This study sought to describe the short-term health status benefits of angiotensin-neprilysin inhibitor (ARNI) therapy in patients with heart failure and reduced ejection fraction (HFrEF). BACKGROUND: Although therapy with sacubitril/valsartan, a neprilysin inhibitor, improved patients' health status (compared with enalapril) at 8 months in the PARADIGM-HF (Prospective Comparison of ARNI with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) study, the early impact of ARNI on patients' symptoms, functions, and quality of life is unknown. METHODS: Health status was assessed by using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ) in 3,918 outpatients with HFrEF and left ventricular ejection fraction ≤40% across 140 U.S. centers in the CHAMP-HF (Change the Management of Patients with Heart Failure) registry. ARNI therapy was initiated in 508 patients who were matched 1:2 to 1,016 patients who were not initiated on ARNI (no-ARNI), using a nonparsimonious time-dependent propensity score (6 sociodemographic factors, 23 clinical characteristics), prior KCCQ overall summary (KCCQ-OS) score, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker status. RESULTS: Multivariate linear regression demonstrated a greater mean improvement in KCCQ-OS in patients initiated on ARNI therapy (5.3 ± 19 vs. 2.5 ± 17.4, respectively; p < 0.001) over a median (interquartile range [IQR]) of 57 (32 to 104) days. The proportions of ARNI versus no-ARNI groups with ≥10-point (large) and ≥20-point (very large) improvements in KCCQ-OS were 32.7% versus 26.9%, respectively, and 20.5% versus 12.1%, respectively, consistent with numbers needed to treat of 18 and 12, respectively. CONCLUSIONS: In routine clinical care, ARNI therapy was associated with early improvements in health status, with 20% experiencing a very large health status benefit compared with 12% who were not started on ARNI therapy. These findings support the use of ARNI to improve patients' symptoms, functions, and quality of life. Published by Elsevier Inc.
OBJECTIVES: This study sought to describe the short-term health status benefits of angiotensin-neprilysin inhibitor (ARNI) therapy in patients with heart failure and reduced ejection fraction (HFrEF). BACKGROUND: Although therapy with sacubitril/valsartan, a neprilysin inhibitor, improved patients' health status (compared with enalapril) at 8 months in the PARADIGM-HF (Prospective Comparison of ARNI with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) study, the early impact of ARNI on patients' symptoms, functions, and quality of life is unknown. METHODS: Health status was assessed by using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ) in 3,918 outpatients with HFrEF and left ventricular ejection fraction ≤40% across 140 U.S. centers in the CHAMP-HF (Change the Management of Patients with Heart Failure) registry. ARNI therapy was initiated in 508 patients who were matched 1:2 to 1,016 patients who were not initiated on ARNI (no-ARNI), using a nonparsimonious time-dependent propensity score (6 sociodemographic factors, 23 clinical characteristics), prior KCCQ overall summary (KCCQ-OS) score, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker status. RESULTS: Multivariate linear regression demonstrated a greater mean improvement in KCCQ-OS in patients initiated on ARNI therapy (5.3 ± 19 vs. 2.5 ± 17.4, respectively; p < 0.001) over a median (interquartile range [IQR]) of 57 (32 to 104) days. The proportions of ARNI versus no-ARNI groups with ≥10-point (large) and ≥20-point (very large) improvements in KCCQ-OS were 32.7% versus 26.9%, respectively, and 20.5% versus 12.1%, respectively, consistent with numbers needed to treat of 18 and 12, respectively. CONCLUSIONS: In routine clinical care, ARNI therapy was associated with early improvements in health status, with 20% experiencing a very large health status benefit compared with 12% who were not started on ARNI therapy. These findings support the use of ARNI to improve patients' symptoms, functions, and quality of life. Published by Elsevier Inc.
Entities:
Keywords:
health status; heart failure; sacubitril/valsartan
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