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

Research output: Contribution to journalArticlepeer-review

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 languageEnglish (US)
Pages (from-to)35-43
Number of pages9
JournalAmerican Heart Journal
Volume230
DOIs
StatePublished - Dec 2020

Bibliographical note

Funding Information:
Disclosures: R. J. M., E. C. O., A. D. D., and A. F. H. receive research support and honoraria from Novartis. M. A. S. receives research grants from Novartis and Aadi and consults for Complexa, Actelion, United Therapeutics, and Acceleron. XS and CID are employees of Novartis Pharmaceuticals Corporation. The remaining authors report no relevant disclosures.

Funding Information:
Funding: PROVIDE-HF was funded by Novartis Pharmaceuticals Corporation (East Hanover, NJ).The PROVIDE-HF study was a prospective investigation of HFrEF outpatients initiated on sacubitril/valsartan versus controls with recent initiation/dose change in angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB) (Clinicaltrials.gov identifier: NCT03387163). PROVIDE-HF was designed as a pragmatic study focused on patient-reported outcomes with limited baseline data collection via traditional measures (ie, electronic case report form [eCRF] data entry) and leveraging of the participants? electronic health record (EHR) data for follow-up through a national research network, Patient-Centered Outcomes Research Network (PCORnet), as described previously6. PROVIDE-HF was designed and overseen by an academic steering committee with funding provided by Novartis Pharmaceuticals Corporation (East Hanover, NJ). All the patients provided written informed consent. The statistical analyses were performed by the Duke Clinical Research Institute independent of the sponsor. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents. Disclosures: R. J. M., E. C. O., A. D. D., and A. F. H. receive research support and honoraria from Novartis. M. A. S. receives research grants from Novartis and Aadi and consults for Complexa, Actelion, United Therapeutics, and Acceleron. XS and CID are employees of Novartis Pharmaceuticals Corporation. The remaining authors report no relevant disclosures.

Funding Information:
Funding: PROVIDE-HF was funded by Novartis Pharmaceuticals Corporation (East Hanover, NJ).

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