Health-Related Quality of Life Outcomes in PARADIGM-HF

Eldrin F. Lewis, Brian L. Claggett, John J.V. McMurray, Milton Packer, Martin P. Lefkowitz, Jean L. Rouleau, Jiankang Liu, Victor C. Shi, Michael R. Zile, Akshay S. Desai, Scott D. Solomon, Karl Swedberg

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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.

Original languageEnglish (US)
Article numbere003430
JournalCirculation: Heart Failure
Volume10
Issue number8
DOIs
StatePublished - Aug 1 2017

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Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Lewis, E. F., Claggett, B. L., McMurray, J. J. V., Packer, M., Lefkowitz, M. P., Rouleau, J. L., Liu, J., Shi, V. C., Zile, M. R., Desai, A. S., Solomon, S. D., & Swedberg, K. (2017). Health-Related Quality of Life Outcomes in PARADIGM-HF. Circulation: Heart Failure, 10(8), [e003430]. https://doi.org/10.1161/CIRCHEARTFAILURE.116.003430