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Circ Heart Fail. 2017 Aug;10(8). pii: e003430. doi: 10.1161/CIRCHEARTFAILURE.116.003430.

Health-Related Quality of Life Outcomes in PARADIGM-HF.

Author information

1
From the Brigham and Women's Hospital, Boston, MA (E.F.L., B.L.C., J.L., A.S.D., S.D.S.); BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.); Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.); Novartis, East Hanover, NJ (M.P.L., V.C.S.); Institut de Cardiologie de Montreal, Université de Montreal, Canada (J.L.R.); Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston, SC (M.R.Z.); and Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden and National Heart and Lung Institute, Imperial College, London, United Kingdom (K.S.). eflewis@partners.org.
2
From the Brigham and Women's Hospital, Boston, MA (E.F.L., B.L.C., J.L., A.S.D., S.D.S.); BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.); Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.); Novartis, East Hanover, NJ (M.P.L., V.C.S.); Institut de Cardiologie de Montreal, Université de Montreal, Canada (J.L.R.); Medical University of South Carolina and RHJ Department of Veterans Administration Medical Center, Charleston, SC (M.R.Z.); and Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden and National Heart and Lung Institute, Imperial College, London, United Kingdom (K.S.).

Abstract

BACKGROUND:

Patients with heart failure and reduced ejection fraction have impaired health-related quality of life (HRQL) with variable responses to therapies that target mortality and heart failure hospitalizations. In PARADIGM-HF trial (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] With ACEI [Angiotensin-Converting-Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure), sacubitril/valsartan reduced morbidity and mortality compared with enalapril. Another major treatment goal is to improve HRQL. Given improvements in mortality with sacubitril/valsartan, this analysis provides comprehensive assessment of impact of therapy on HRQL in survivors only.

METHODS AND RESULTS:

Patients (after run-in phase) completed disease-specific HRQL using Kansas City Cardiomyopathy Questionnaire (KCCQ) at randomization, 4 month, 8 month, and annual visits. Changes in KCCQ scores were calculated using repeated measures analysis of covariance model that adjusted for treatment and baseline values (principal efficacy prespecified at 8 months). Among the 8399 patients enrolled in PARADIGM-HF, 7623 (91%) completed KCCQ scores at randomization with complete data at 8 months for 6881 patients (90% of baseline). At 8 months, sacubitril/valsartan group noted improvements in both KCCQ clinical summary score (+0.64 versus -0.29; P=0.008) and KCCQ overall summary score (+1.13 versus -0.14; P<0.001) in comparison to enalapril group and significantly less proportion of patients with deterioration (≥5 points decrease) of both KCCQ scores (27% versus 31%; P=0.01). Adjusted change scores demonstrated consistent improvements in sacubitril/valsartan compared with enalapril through 36 months.

CONCLUSIONS:

Change scores in KCCQ clinical summary scores and KCCQ overall summary scores were better in patients treated with sacubitril/valsartan compared with those treated with enalapril, with consistency in most domains, and persist during follow-up beyond 8 months. These findings demonstrate that sacubitril/valsartan leads to better HRQL in surviving patients with heart failure.

CLINICAL TRIAL REGISTRATION:

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255.

KEYWORDS:

clinical trial; heart failure; neprilysin inhibitor; predictors; quality of life; sacubitril/valsartan

[Indexed for MEDLINE]

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