Sacubitril/valsartan eligibility and outcomes in the ESC-EORP-HFA Heart Failure Long-Term Registry: bridging between European Medicines Agency/Food and Drug Administration label, the PARADIGM-HF trial, ESC guidelines, and real world.
Angiotensin receptor-neprilysin inhibitor
Eligibility
LCZ696
Prognosis
Registry
Sacubitril/valsartan
Journal
European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
received:
30
04
2019
revised:
15
05
2019
accepted:
17
05
2019
pubmed:
28
5
2019
medline:
19
5
2020
entrez:
28
5
2019
Statut:
ppublish
Résumé
To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM-HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes. Outpatients with HFrEF in the ESC-EORP-HFA Long-Term Heart Failure (HF-LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM-HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM-HF and guideline criteria, respectively. Absent PARADIGM-HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub-optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%) and sub-optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM-HF and guidelines. One-year heart failure hospitalization was higher (12% and 17% vs. 12%) and all-cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM-HF. Among outpatients with HFrEF in the ESC-EORP-HFA HF-LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM-HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM-HF enalapril group.
Substances chimiques
Aminobutyrates
0
Angiotensin Receptor Antagonists
0
Biphenyl Compounds
0
Drug Combinations
0
Tetrazoles
0
Valsartan
80M03YXJ7I
Neprilysin
EC 3.4.24.11
sacubitril and valsartan sodium hydrate drug combination
WB8FT61183
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1383-1397Investigateurs
J Auer
(J)
K Ablasser
(K)
F Fruhwald
(F)
T Dolze
(T)
K Brandner
(K)
S Gstrein
(S)
G Poelzl
(G)
D Moertl
(D)
S Reiter
(S)
A Podczeck-Schweighofer
(A)
A Muslibegovic
(A)
M Vasilj
(M)
E Fazlibegovic
(E)
M Cesko
(M)
D Zelenika
(D)
B Palic
(B)
D Pravdic
(D)
D Cuk
(D)
K Vitlianova
(K)
T Katova
(T)
T Velikov
(T)
T Kurteva
(T)
P Gatzov
(P)
D Kamenova
(D)
M Antova
(M)
V Sirakova
(V)
J Krejci
(J)
M Mikolaskova
(M)
J Spinar
(J)
J Krupicka
(J)
F Malek
(F)
M Hegarova
(M)
M Lazarova
(M)
Z Monhart
(Z)
M Hassanein
(M)
M Sobhy
(M)
F El Messiry
(F)
A H El Shazly
(AH)
Y Elrakshy
(Y)
A Youssef
(A)
A A Moneim
(AA)
M Noamany
(M)
A Reda
(A)
T K Abdel Dayem
(TK)
N Farag
(N)
S Ibrahim Halawa
(S)
M Abdel Hamid
(M)
K Said
(K)
A Saleh
(A)
H Ebeid
(H)
R Hanna
(R)
R Aziz
(R)
O Louis
(O)
M A Enen
(MA)
B S Ibrahim
(BS)
G Nasr
(G)
A Elbahry
(A)
H Sobhy
(H)
M Ashmawy
(M)
M Gouda
(M)
W Aboleineen
(W)
Y Bernard
(Y)
P Luporsi
(P)
N Meneveau
(N)
M Pillot
(M)
M Morel
(M)
M-F Seronde
(MF)
F Schiele
(F)
F Briand
(F)
F Delahaye
(F)
T Damy
(T)
J-C Eicher
(JC)
P de Groote
(P)
M Fertin
(M)
N Lamblin
(N)
R Isnard
(R)
C Lefol
(C)
S Thevenin
(S)
A Hagege
(A)
G Jondeau
(G)
D Logeart
(D)
V Le Marcis
(V)
J-F Ly
(JF)
D Coisne
(D)
B Lequeux
(B)
V Le Moal
(V)
S Mascle
(S)
P Lotton
(P)
N Behar
(N)
E Donal
(E)
C Thebault
(C)
C Ridard
(C)
A Reynaud
(A)
A Basquin
(A)
F Bauer
(F)
R Codjia
(R)
M Galinier
(M)
P Tourikis
(P)
M Stavroula
(M)
D Tousoulis
(D)
C Stefanadis
(C)
C Chrysohoou
(C)
I Kotrogiannis
(I)
V Matzaraki
(V)
T Dimitroula
(T)
A Karavidas
(A)
G Tsitsinakis
(G)
C Kapelios
(C)
J Nanas
(J)
H Kampouri
(H)
E Nana
(E)
E Kaldara
(E)
A Eugenidou
(A)
P Vardas
(P)
I Saloustros
(I)
A Patrianakos
(A)
T Tsaknakis
(T)
S Evangelou
(S)
N Nikoloulis
(N)
H Tziourganou
(H)
A Tsaroucha
(A)
A Papadopoulou
(A)
A Douras
(A)
L Polgar
(L)
B Merkely
(B)
A Kosztin
(A)
N Nyolczas
(N)
A Csaba Nagy
(A)
R Halmosi
(R)
J Elber
(J)
I Alony
(I)
A Shotan
(A)
A Vazan Fuhrmann
(A)
O Amir
(O)
S Romano
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A Squeri
(A)
A Barbieri
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G Di Tano
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(R)
A Fucili
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(T)
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(S)
M Di Biase
(M)
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(M)
G Salvemini
(G)
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E Zanelli
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M G Modena
(MG)
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A Minacapelli
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A Gualco
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M Pagliaro
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F Fedele
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A Cinque
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M Vellini
(M)
I Scarfo
(I)
F Romeo
(F)
F Ferraiuolo
(F)
D Sergi
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M Anselmi
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E Leci
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E Iori
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V Bovolo
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S Pidello
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S Frea
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(S)
M Botta
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F G Canavosio
(FG)
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M Merlo
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M Cinquetti
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G Sinagra
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F Ramani
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E Fabris
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A Proclemer
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M Cicoira
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L Zanolla
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G Marchese
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N Voronina
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A Erglis
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V Tamakauskas
(V)
V Smalinskas
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R Karaliute
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Z Juszczyk
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W Sinkiewicz
(W)
W Gilewski
(W)
J Pietrzak
(J)
T Orzel
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P Kasztelowicz
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M Lazorko-Piega
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J Gabryel
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K Mosakowska
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J Bellwon
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A Rynkiewicz
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E Lewicka
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R Bartkowiak
(R)
B Sosnowska-Pasiarska
(B)
B Wozakowska-Kaplon
(B)
A Krzeminski
(A)
M Zabojszcz
(M)
E Mirek-Bryniarska
(E)
A Grzegorzko
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K Bury
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J Nessler
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J Zalewski
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A Furman
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M Rudzinska
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L Jankowski
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J D Kasprzak
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K Szymanowska
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J Grabia
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K Przybylska
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M Deljanin Ilic
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J Stojiljkovic
(J)
B Mihajlovic
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A Radin
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S Radovanovic
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A Klabnik
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E Goncalvesova
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M Pernicky
(M)
J Murin
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F Kovar
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J Kmec
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M Savnik Iskra
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M Valentincic
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A Bartolic
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B Drnovsek
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J Gonzalez-Costello
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A Garay
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V Alcade-Martinez
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S Lopez Fernandez
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R Rivera-Lopez
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M Puga-Martinez
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M Fernandez-Alvarez
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J L Serrano-Martinez
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I Laynez Cerdena
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I Famara Hernandez Baldomero
(I)
A Lara Padron
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S Ofelia Rosillo
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R Dalmau Gonzalez-Gallarza
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O Salvador Montanes
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A M Iniesta Manjavacas
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A Castro Conde
(A)
A Araujo
(A)
T Soria
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P Garcia-Pavia
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M Gomez-Bueno
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M Cobo-Marcos
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J Segovia Cubero
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I Sayago
(I)
A Gonzalez-Segovia
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A Briceno
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P Escribano Subias
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M Vicente Hernandez
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M J Ruiz Cano
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M A Gomez Sanchez
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J F Delgado Jimenez
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E Barrios Garrido-Lestache
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J M Garcia Pinilla
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B Garcia de la Villa
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A Sahuquillo
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R Bravo Marques
(R)
F Torres Calvo
(F)
M T Perez-Martinez
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M R Gracia-Rodenas
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I P Garrido-Bravo
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F Pastor-Perez
(F)
D A Pascual-Figal
(DA)
B Diaz Molina
(B)
J Orus
(J)
F Epelde Gonzalo
(F)
V Bertomeu
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R Valero
(R)
R Martinez-Abellan
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J Quiles
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J A Rodrigez-Ortega
(JA)
I Mateo
(I)
A ElAmrani
(A)
C Fernandez-Vivancos
(C)
D Bierge Valero
(D)
L Almenar-Bonet
(L)
I J Sanchez-Lazaro
(IJ)
E Marques-Sule
(E)
L Facila-Rubio
(L)
J Perez-Silvestre
(J)
P Garcia-Gonzalez
(P)
F Ridocci-Soriano
(F)
D Garcia-Escriva
(D)
A Pellicer-Cabo
(A)
L de la Fuente Galan
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J Lopez Diaz
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A Recio Platero
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J C Arias
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T Blasco-Peiro
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M Sanz Julve
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E Sanchez-Insa
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C Aured-Guallar
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A Portoles-Ocampo
(A)
M Melin
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E Hägglund
(E)
A Stenberg
(A)
I-M Lindahl
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B Asserlund
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L Olsson
(L)
U Dahlström
(U)
M Afzelius
(M)
P Karlström
(P)
L Tengvall
(L)
P-A Wiklund
(PA)
B Olsson
(B)
S Kalayci
(S)
A Temizhan
(A)
Y Cavusoglu
(Y)
E Gencer
(E)
M B Yilmaz
(MB)
H Gunes
(H)
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 The Authors. European Journal of Heart Failure © 2019 European Society of Cardiology.
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