Skip to main content
Journal cover image

PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure.

Publication ,  Journal Article
Mentz, RJ; Xu, H; O'Brien, EC; Thomas, L; Alexy, T; Gupta, B; Vilaro, J; Lala, A; DeVore, AD; Dhingra, R; Briasoulis, A; Simon, MA; Wells, QS ...
Published in: Am Heart J
December 2020

BACKGROUND: In PARADIGM-HF, sacubitril/valsartan improved quality of life (QOL) versus enalapril in heart failure with reduced ejection fraction (HFrEF), yet limited data are available regarding QOL changes after sacubitril/valsartan initiation in routine practice. METHODS: PROVIDE-HF was a prospective study within a national research network (Patient-Centered Outcomes Research Network) of HFrEF outpatients recently initiated on sacubitril/valsartan versus controls with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change. The primary end point was mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change through 12 weeks. Other end points included responder analyses: ≥5-point and ≥20-point KCCQ increase. Adjusted QOL change was estimated after propensity score weighting. RESULTS: Overall, 270 patients had both baseline and 12-week KCCQ data (151 sacubitril/valsartan; 119 control). The groups had similar demographics and HF details: median EF 28% and N-terminal pro-brain natriuretic peptide 1083 pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference +4.76; P = .027) and were more likely to have a ≥5-point and ≥20-point response (all P < .05). Adjusted comparisons demonstrated similar numerical improvements in the change in KCCQ (+4.55; 95% CI -0.89 to 9.99; P = .101) and likelihood of ≥5-point increase (odds ratio 1.55; 95% CI: 0.84-2.86; P = .16); ≥20-point increase remained statistically significant (odds ratio 3.79; 95% CI 1.47-9.73; P = .006). CONCLUSIONS: In this prospective HFrEF study of sacubitril/valsartan initiation compared with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change, the between-group difference in the primary end point, mean KCCQ change at 12 weeks was not statistically significant following adjustment, but sacubitril/valsartan initiation was associated with early improvements in QOL and a higher likelihood of ≥20-point improvement in KCCQ at 12 weeks. These data add additional real-world evidence related to patient-reported outcomes following the initiation of sacubitril/valsartan in routine clinical practice.

Duke Scholars

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

December 2020

Volume

230

Start / End Page

35 / 43

Location

United States

Related Subject Headings

  • Valsartan
  • Tetrazoles
  • Quality of Life
  • Prospective Studies
  • Propensity Score
  • Preliminary Data
  • Peptide Fragments
  • Patient Reported Outcome Measures
  • Natriuretic Peptide, Brain
  • Middle Aged
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Mentz, R. J., Xu, H., O’Brien, E. C., Thomas, L., Alexy, T., Gupta, B., … Hernandez, A. F. (2020). PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure. Am Heart J, 230, 35–43. https://doi.org/10.1016/j.ahj.2020.09.012
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

December 2020

Volume

230

Start / End Page

35 / 43

Location

United States

Related Subject Headings

  • Valsartan
  • Tetrazoles
  • Quality of Life
  • Prospective Studies
  • Propensity Score
  • Preliminary Data
  • Peptide Fragments
  • Patient Reported Outcome Measures
  • Natriuretic Peptide, Brain
  • Middle Aged