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Health-Related Qual...
Health-Related Quality of Life Outcomes in PARADIGM-HF
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Lewis, Eldrin F. (author)
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Claggett, Brian L. (author)
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McMurray, John J.V. (author)
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Packer, Milton (author)
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Lefkowitz, Martin P. (author)
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Rouleau, Jean L. (author)
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Liu, Jiankang (author)
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Shi, Victor C. (author)
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Zile, Michael R. (author)
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Desai, Akshay S. (author)
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Solomon, Scott D. (author)
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- Swedberg, Karl, 1944 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine
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(creator_code:org_t)
- 2017
- 2017
- English.
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In: Circulation: Heart Failure. - 1941-3289 .- 1941-3297. ; 10
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
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- © 2017 American Heart Association, Inc. 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Keyword
- clinical trial
- heart failure
- neprilysin inhibitor
- predictors
- quality of life
- sacubitril/valsartan
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Lewis, Eldrin F.
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Claggett, Brian ...
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McMurray, John J ...
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Packer, Milton
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Lefkowitz, Marti ...
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Rouleau, Jean L.
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show more...
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Liu, Jiankang
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Shi, Victor C.
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Zile, Michael R.
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Desai, Akshay S.
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Solomon, Scott D ...
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Swedberg, Karl, ...
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
- Articles in the publication
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Circulation: Hea ...
- By the university
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University of Gothenburg