Health-related quality of life outcomes in PARADIGM-HF

Lewis, E. F. et al. (2017) Health-related quality of life outcomes in PARADIGM-HF. Circulation: Heart Failure, 10(8), e003430. (doi: 10.1161/CIRCHEARTFAILURE.116.003430) (PMID:28784687)

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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.

Item Type:Articles
Additional Information:This study was supported by Novartis.
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: 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., and Swedberg, K.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Journal Name:Circulation: Heart Failure
Publisher:American Heart Association
ISSN (Online):1941-3297
Published Online:07 August 2017

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