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

Robert J. Mentz; Haolin Xu; Emily C. O'Brien; Laine Thomas; Tamas Alexy; Bhanu Gupta; Juan Vilaro; Anuradha Lala; Adam D. DeVore; Ravi Dhingra; Alexandros Briasoulis; Marc A. Simon; Josef Stehlik; Jo E. Rodgers; Shannon M. Dunlay; Martha Abshire; Quinn S. Wells; Kurt G. Barringhaus; Peter M. Eckman; Brian D. Lowes; Johana Espinoza; Rosalia Blanco; Xian Shen; Carol I. Duffy; Adrian F. Hernandez

doi:10.1016/j.ahj.2020.09.012

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

Robert J. Mentz, Haolin Xu, Emily C. O'Brien, Laine Thomas, Tamas Alexy, Bhanu Gupta, Juan Vilaro, Anuradha Lala, Adam D. DeVore, Ravi Dhingra, Alexandros Briasoulis, Marc A. Simon, Josef Stehlik, Jo E. Rodgers, Shannon M. Dunlay, Martha Abshire, Quinn S. Wells, Kurt G. Barringhaus, Peter M. Eckman, Brian D. LowesJohana Espinoza, Rosalia Blanco, Xian Shen, Carol I. Duffy, Adrian F. Hernandez

Medicine - Cardiology Division

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	35-43
Number of pages	9
Journal	American Heart Journal
Volume	230
DOIs	https://doi.org/10.1016/j.ahj.2020.09.012
State	Published - Dec 2020

Bibliographical note

Publisher Copyright:
© 2020 Elsevier Inc.

Keywords

Aged
Aminobutyrates/administration & dosage
Angiotensin Receptor Antagonists/administration & dosage
Angiotensin-Converting Enzyme Inhibitors/administration & dosage
Case-Control Studies
Drug Combinations
Female
Heart Failure/drug therapy
Humans
Male
Middle Aged
Natriuretic Peptide, Brain/blood
Patient Reported Outcome Measures
Peptide Fragments/blood
Preliminary Data
Propensity Score
Prospective Studies
Quality of Life
Tetrazoles/administration & dosage

PubMed: MeSH publication types

Research Support, Non-U.S. Gov't
Observational Study
Journal Article

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Publisher link

10.1016/j.ahj.2020.09.012

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Mentz, R. J., Xu, H., O'Brien, E. C., Thomas, L., Alexy, T., Gupta, B., Vilaro, J., Lala, A., DeVore, A. D., Dhingra, R., Briasoulis, A., Simon, M. A., Stehlik, J., Rodgers, J. E., Dunlay, S. M., Abshire, M., Wells, Q. S., Barringhaus, K. G., Eckman, P. M., ... Hernandez, A. F. (2020). PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure. American Heart Journal, 230, 35-43. https://doi.org/10.1016/j.ahj.2020.09.012

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, Stehlik, J, Rodgers, JE, Dunlay, SM, Abshire, M, Wells, QS, Barringhaus, KG, Eckman, PM, Lowes, BD, Espinoza, J, Blanco, R, Shen, X, Duffy, CI & Hernandez, AF 2020, 'PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure', American Heart Journal, vol. 230, pp. 35-43. https://doi.org/10.1016/j.ahj.2020.09.012

@article{daacc07717724ad1a3a33c4a6667daab,

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

abstract = "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.",

keywords = "Aged, Aminobutyrates/administration & dosage, Angiotensin Receptor Antagonists/administration & dosage, Angiotensin-Converting Enzyme Inhibitors/administration & dosage, Case-Control Studies, Drug Combinations, Female, Heart Failure/drug therapy, Humans, Male, Middle Aged, Natriuretic Peptide, Brain/blood, Patient Reported Outcome Measures, Peptide Fragments/blood, Preliminary Data, Propensity Score, Prospective Studies, Quality of Life, Tetrazoles/administration & dosage",

author = "Mentz, {Robert J.} and Haolin Xu and O'Brien, {Emily C.} and Laine Thomas and Tamas Alexy and Bhanu Gupta and Juan Vilaro and Anuradha Lala and DeVore, {Adam D.} and Ravi Dhingra and Alexandros Briasoulis and Simon, {Marc A.} and Josef Stehlik and Rodgers, {Jo E.} and Dunlay, {Shannon M.} and Martha Abshire and Wells, {Quinn S.} and Barringhaus, {Kurt G.} and Eckman, {Peter M.} and Lowes, {Brian D.} and Johana Espinoza and Rosalia Blanco and Xian Shen and Duffy, {Carol I.} and Hernandez, {Adrian F.}",

note = "Publisher Copyright: {\textcopyright} 2020 Elsevier Inc.",

year = "2020",

month = dec,

doi = "10.1016/j.ahj.2020.09.012",

language = "English (US)",

volume = "230",

pages = "35--43",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Mosby Inc.",

}

TY - JOUR

T1 - PROVIDE-HF primary results

T2 - Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure

AU - Mentz, Robert J.

AU - Xu, Haolin

AU - O'Brien, Emily C.

AU - Thomas, Laine

AU - Alexy, Tamas

AU - Gupta, Bhanu

AU - Vilaro, Juan

AU - Lala, Anuradha

AU - DeVore, Adam D.

AU - Dhingra, Ravi

AU - Briasoulis, Alexandros

AU - Simon, Marc A.

AU - Stehlik, Josef

AU - Rodgers, Jo E.

AU - Dunlay, Shannon M.

AU - Abshire, Martha

AU - Wells, Quinn S.

AU - Barringhaus, Kurt G.

AU - Eckman, Peter M.

AU - Lowes, Brian D.

AU - Espinoza, Johana

AU - Blanco, Rosalia

AU - Shen, Xian

AU - Duffy, Carol I.

AU - Hernandez, Adrian F.

PY - 2020/12

Y1 - 2020/12

N2 - 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.

AB - 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.

KW - Aged

KW - Aminobutyrates/administration & dosage

KW - Angiotensin Receptor Antagonists/administration & dosage

KW - Angiotensin-Converting Enzyme Inhibitors/administration & dosage

KW - Case-Control Studies

KW - Drug Combinations

KW - Female

KW - Heart Failure/drug therapy

KW - Humans

KW - Male

KW - Middle Aged

KW - Natriuretic Peptide, Brain/blood

KW - Patient Reported Outcome Measures

KW - Peptide Fragments/blood

KW - Preliminary Data

KW - Propensity Score

KW - Prospective Studies

KW - Quality of Life

KW - Tetrazoles/administration & dosage

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UR - http://www.scopus.com/inward/citedby.url?scp=85092729201&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2020.09.012

DO - 10.1016/j.ahj.2020.09.012

M3 - Article

C2 - 32980364

AN - SCOPUS:85092729201

SN - 0002-8703

VL - 230

SP - 35

EP - 43

JO - American Heart Journal

JF - American Heart Journal

ER -

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

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

UN SDGs

Publisher link

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