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, 2020 12.
Article
in En
| MEDLINE
| ID: mdl-32980364
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 12â¯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 1083â¯pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference +4.76; Pâ¯=â¯.027) and were more likely to have aâ¯≥5-point andâ¯≥20-point response (all Pâ¯<â¯.05). Adjusted comparisons demonstrated similar numerical improvements in the change in KCCQ (+4.55; 95% CI -0.89 to 9.99; Pâ¯=â¯.101) and likelihood of ≥5-point increase (odds ratio 1.55; 95% CI 0.84-2.86; Pâ¯=â¯.16); ≥20-point increase remained statistically significant (odds ratio 3.79; 95% CI 1.47-9.73; Pâ¯=â¯.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 12â¯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 12â¯weeks. These data add additional real-world evidence related to patient-reported outcomes following the initiation of sacubitril/valsartan in routine clinical practice.
Full text:
1
Database:
MEDLINE
Main subject:
Quality of Life
/
Tetrazoles
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Patient Reported Outcome Measures
/
Preliminary Data
/
Aminobutyrates
/
Heart Failure
Type of study:
Observational_studies
/
Risk_factors_studies
Limits:
Aged
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Female
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Humans
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Male
/
Middle aged
Language:
En
Journal:
Am Heart J
Year:
2020
Type:
Article