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2018 ; 5
(3
): 275-283
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Insights into implementation of sacubitril/valsartan into clinical practice
#MMPMID29464879
Martens P
; Beliën H
; Dupont M
; Mullens W
ESC Heart Fail
2018[Jun]; 5
(3
): 275-283
PMID29464879
show ga
BACKGROUND: Sacubitril/valsartan significantly reduced heart failure
hospitalization and mortality in PARADIGM-HF (Prospective Comparison of
Angiotensin Receptor-Neprilysin Inhibitor With an Angiotensin-Converting Enzyme
Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart
Failure). However, real-world data from its use are lacking. METHODS AND RESULTS:
We retrospectively assessed all baseline and follow-up data of consecutive heart
failure patients with reduced ejection fraction receiving therapy with
sacubitril/valsartan for Class I recommendation between December 2016 and July
2017. Baseline characteristics and dose titration of sacubitril/valsartan were
compared between patients in clinical practice and in PARADIGM-HF. A total of 120
patients (81% male) were switched from angiotensin-converting enzyme inhibitor or
angiotensin receptor blocker to sacubitril/valsartan. A total of 20.1% of
patients received dose uptitration. Patients were treated with an equipotential
dose of renin-angiotensin system blockers before and after uptitration of
sacubitril/valsartan (57 ± 29% vs. 53 ± 29% of target dose indicated by European
Society of Cardiology guidelines; P = 0.286). However, they received a lower dose
of sacubitril/valsartan in comparison with those in the PARADIGM-HF (219 ± 12 vs.
375 ± 75 mg; P < 0.001). In comparison with the patients receiving
sacubitril/valsartan in PARADIGM-HF, patients in clinical practice were older and
had a higher serum creatinine, higher New York Heart Association functional
classification, and lower left ventricular ejection fraction (all P-value <0.05).
Even in comparison with patients who experienced dropout during the run-in phase
of PARADIGM-HF, real-world patients exhibited baseline characteristics indicative
of more disease severity. Patients were at high absolute baseline risk for
adverse outcome as illustrated by the EMPHASIS-HF (Eplerenone in Mild Patients
Hospitalization and Survival Study in Heart Failure) risk score of 6
(inter-quartile range 3), in comparison with 5 (inter-quartile range 4) in
PARADIGM-HF. After initiation of sacubitril/valsartan, New York Heart Association
class significantly improved (P < 0.001), but systolic blood pressure dropped
more than was reported in PARADIGM-HF (7.1 ± 8.0 vs. 3.2 ± 0.4 mmHg; P < 0.001).
CONCLUSIONS: Patients in clinical practice exhibit baseline characteristics
associated with more severe disease, which might lead to prescription of lower
doses. Nevertheless, patients in clinical practice are at high risk of adverse
outcome as illustrated by the EMPHASIS-HF risk score, underscoring the large
potential for sacubitril/valsartan therapy to reduce the risk of heart failure
hospitalization and all-cause mortality.
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