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Improvement of Health Status Following Initiation of Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction.

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Piña, IL; Camacho, A; Ibrahim, NE; Felker, GM; Butler, J; Maisel, AS; Prescott, MF; Williamson, KM; Claggett, BL; Desai, AS; Solomon, SD ...
Published in: JACC Heart Fail
January 2021

BACKGROUND: Treatment of heart failure with reduced ejection fraction (EF) may improve patient-reported health outcomes. OBJECTIVES: The purpose of this study was to determine timing and magnitude of change in Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 scores following initiation of sacubitril/valsartan and interaction with change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations. METHODS: From a single-arm, open-label study of patients initiated on sacubitril/valsartan, KCCQ-23 scores and NT-proBNP were obtained at baseline and follow-up through 12 months. Cross-sectional and longitudinal analyses evaluated magnitude and rate of change in KCCQ-23 scores and associations with NT-proBNP. Patient-level data from the randomized EVALUATE-HF study were used as historic controls. RESULTS: The analysis cohort (n = 678, age 64.7 years, 71.5% men, EF 28.9%) had a baseline KCCQ-23 overall score (OS) of 65.6. Following sacubitril/valsartan initiation, the majority (n = 412; 60.8%) of participants experienced a rise in KCCQ-23 OS ≥10 points; 26.0% increased by ≥20 points. Comparable improvement in KCCQ-23 scores was seen in various subgroups. Change in KCCQ-23 OS was inversely associated with change in circulating NT-proBNP concentrations. Among a control group of patients in EVALUATE-HF, linear rate of change in KCCQ-12 OS/14-day interval in the enalapril arm was 0.37 points (p = 0.06), whereas in the sacubitril/valsartan arm, scores increased at a rate of 1.19 points (p < 0.001), nearly identical to this dataset (1.08 points; p < 0.001). CONCLUSIONS: Treatment of heart failure with reduced EF with sacubitril/valsartan is associated with rapid and significant improvement in KCCQ-23 scores which was significantly related to change in NT-proBNP. (Effects of Sacubitril/Valsartan Therapy on Biomarkers, Myocardial Remodeling and Outcomes [PROVE-HF]; NCT02887183).

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Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

January 2021

Volume

9

Issue

1

Start / End Page

42 / 51

Location

United States

Related Subject Headings

  • Valsartan
  • Tetrazoles
  • Stroke Volume
  • Middle Aged
  • Male
  • Humans
  • Heart Failure
  • Health Status
  • Female
  • Drug Combinations
 

Citation

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Piña, I. L., Camacho, A., Ibrahim, N. E., Felker, G. M., Butler, J., Maisel, A. S., … PROVE-HF Investigators, . (2021). Improvement of Health Status Following Initiation of Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction. In JACC Heart Fail (Vol. 9, pp. 42–51). United States. https://doi.org/10.1016/j.jchf.2020.09.012
Piña, Ileana L., Alexander Camacho, Nasrien E. Ibrahim, G Michael Felker, Javed Butler, Alan S. Maisel, Margaret F. Prescott, et al. “Improvement of Health Status Following Initiation of Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction.” In JACC Heart Fail, 9:42–51, 2021. https://doi.org/10.1016/j.jchf.2020.09.012.
Piña IL, Camacho A, Ibrahim NE, Felker GM, Butler J, Maisel AS, et al. Improvement of Health Status Following Initiation of Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction. In: JACC Heart Fail. 2021. p. 42–51.
Piña, Ileana L., et al. “Improvement of Health Status Following Initiation of Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction.JACC Heart Fail, vol. 9, no. 1, 2021, pp. 42–51. Pubmed, doi:10.1016/j.jchf.2020.09.012.
Piña IL, Camacho A, Ibrahim NE, Felker GM, Butler J, Maisel AS, Prescott MF, Williamson KM, Claggett BL, Desai AS, Solomon SD, Januzzi JL, PROVE-HF Investigators. Improvement of Health Status Following Initiation of Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction. JACC Heart Fail. 2021. p. 42–51.
Journal cover image

Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

January 2021

Volume

9

Issue

1

Start / End Page

42 / 51

Location

United States

Related Subject Headings

  • Valsartan
  • Tetrazoles
  • Stroke Volume
  • Middle Aged
  • Male
  • Humans
  • Heart Failure
  • Health Status
  • Female
  • Drug Combinations