PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure - 26/11/20
, Haolin Xu, MS a, Emily C. O'Brien, PhD a, Laine Thomas, PhD a, Tamas Alexy, MD c, Bhanu Gupta, MD d, Juan Vilaro, MD e, Anuradha Lala, MD f, Adam D. DeVore, MD, MHS a, b, Ravi Dhingra, MD g, Alexandros Briasoulis, MD, PhD h, Marc A. Simon, MD, MS i, Josef Stehlik, MD, MPH j, Jo E. Rodgers, PharmD k, Shannon M. Dunlay, MD, MS l, Martha Abshire, PhD, RN m, Quinn S. Wells, MD, MSCI n, Kurt G. Barringhaus, MD o, Peter M. Eckman, MD p, Brian D. Lowes, MD, PhD q, Johana Espinoza a, Rosalia Blanco, MBA a, Xian Shen, PhD r, Carol I. Duffy, DO r, Adrian F. Hernandez, MD, MHS a, bAbstract |
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.
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| ☆ | Justin Ezekowitz, MBBCh, Clin Inv, served as guest editor for this article. |
| ☆☆ | Funding: PROVIDE-HF was funded by Novartis Pharmaceuticals Corporation (East Hanover, NJ). |
| ☆☆☆ | 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. |
| ☆☆☆☆ | Clinicaltrials.gov identifier: NCT03387163 |
Vol 230
P. 35-43 - décembre 2020 Retour au numéro
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