PMID- 34321170
OWN - NLM
STAT- MEDLINE
DCOM- 20210812
LR  - 20220401
IS  - 1950-6007 (Electronic)
IS  - 0753-3322 (Print)
IS  - 0753-3322 (Linking)
VI  - 130
DP  - 2020 Oct
TI  - The role of sacubitril/valsartan in the treatment of chronic heart failure with 
      reduced ejection fraction in hypertensive patients with comorbidities: From 
      clinical trials to real-world settings.
PG  - 110596
LID - S0753-3322(20)30789-7 [pii]
LID - 10.1016/j.biopha.2020.110596 [doi]
AB  - BACKGROUND: Sacubitril/valsartan, the first agent to be approved in a new class 
      of drugs called angiotensin receptor neprilysin inhibitors (ARNIs), has been 
      shown to reduce cardiovascular mortality and morbidity compared to enalapril in 
      outpatient subjects with chronic heart failure (HF) and reduced left ventricular 
      ejection fraction (HFrEF). However, there is little real-world evidence about the 
      efficacy of ARNIs in elderly hypertensive patients with HFrEF and comorbidities. 
      METHODS: In this prospective open-label study, 108 subjects, 54 of them (mean age 
      78.6 +/- 8.2 years, 75.0 % male), with HFrEF (29.8 +/- 4.3 %) and New York Heart 
      Association (NYHA) class II-III symptoms were assigned to receive ARNIs twice 
      daily, according to the recommended dosage of 24/26, 49/51, 97/103 mg. Patients 
      were gender- and age-matched with a control arm of patients with HFrEF receiving 
      the optimal standard therapy for HF. The clinic blood pressure (BP), N-terminal 
      pro-B-type natriuretic peptide (NT-proBNP), estimated glomerular filtration rate 
      (eGFR), blood glucose and glycated hemoglobin (HbA1c), uric acid (UA), left 
      ventricular ejection fraction (LVEF) and NYHA class were evaluated at a mean 
      follow-up of 12 months. During the follow-up, the clinical outcomes, including 
      mortality and re-hospitalization for HF, were collected. RESULTS: NYHA class 
      significantly improved in the ARNI arm compared to the control (24.9 vs. 6.4 %, 
      shifting from class III to II, and 55.4 vs. 25.2 %, from class II to I, p < 0.05 
      for all). A significant improvement in LVEF and eGFR levels was found in the ARNI 
      arm compared to controls (42.4 vs. 34.2 %, 73.8 vs. 61.2 mL/min, respectively; 
      p < 0.001 for all). NT-proBNP, clinic systolic and diastolic BP, blood glucose, 
      HbA1c and UA values were reduced in both treatment arms, but they were lower in 
      the ARNI arm compared controls (3107 vs. 4552 pg/mL, 112.2 vs. 120.4 and 68.8 vs. 
      75.6 mmHg, 108.4 vs. 112.6 mg/dL, 5.4 vs. 5.9 % and 5.9 vs. 6.4 mg/dL, 
      respectively, p < 0.05). Mortality and re-hospitalization for HF was lower in the 
      ARNI arm than controls (20.1 vs. 33.6 % and 27.7 vs. 46.3 % respectively; 
      p < 0.05 for all). Gender differences were not found in either arm. No patients 
      refused to continue the study, and no side effects to the ARNI treatment were 
      observed. CONCLUSIONS: In elderly patients with HFrEF and comorbidities, ARNI 
      treatment seems effective and safe. The improvement in LVEF and cardiac 
      remodeling, BP, eGFR, serum glucose, UA and HbA1c could be the mechanisms by 
      which ARNIs play their beneficial role on clinical outcomes. However, these 
      results need to be confirmed in studies involving a greater number of subjects, 
      and with a longer follow-up.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier Masson SAS.. All rights 
      reserved.
FAU - Mazza, Alberto
AU  - Mazza A
AD  - ESH Excellence Hypertension Centre, Internal Medicine Unit, S. Maria della 
      Misericordia General Hospital, AULSS 5 Polesana, Rovigo, Italy. Electronic 
      address: Xalberto.mazza@aulss5.veneto.it.
FAU - Townsend, Danyelle M
AU  - Townsend DM
AD  - Department of Drug Discovery and Biomedical Sciences, Medical University of South 
      Carolina, USA.
FAU - Torin, Gioia
AU  - Torin G
AD  - ESH Excellence Hypertension Centre, Internal Medicine Unit, S. Maria della 
      Misericordia General Hospital, AULSS 5 Polesana, Rovigo, Italy; Unit of Internal 
      Medicine, S. Maria della Misericordia General Hospital, AULSS 5 Polesana, Rovigo, 
      Italy.
FAU - Schiavon, Laura
AU  - Schiavon L
AD  - ESH Excellence Hypertension Centre, Internal Medicine Unit, S. Maria della 
      Misericordia General Hospital, AULSS 5 Polesana, Rovigo, Italy; Unit of Internal 
      Medicine, S. Maria della Misericordia General Hospital, AULSS 5 Polesana, Rovigo, 
      Italy.
FAU - Camerotto, Alessandro
AU  - Camerotto A
AD  - Department of Diagnosis and Care, Clinical Laboratory, S. Maria della 
      Misericordia General Hospital, Rovigo, Italy.
FAU - Rigatelli, Gianluca
AU  - Rigatelli G
AD  - Interventional Cardiology Unit, Division of Cardiology, S. Maria della 
      Misericordia General Hospital, AULSS 5 Polesana, Rovigo, Italy.
FAU - Cuppini, Stefano
AU  - Cuppini S
AD  - Unit of Internal Medicine, S. Maria della Misericordia General Hospital, AULSS 5 
      Polesana, Rovigo, Italy.
FAU - Minuz, Pietro
AU  - Minuz P
AD  - Unit of Internal Medicine C, Department of Medicine, University of Verona, 
      Verona, Italy.
FAU - Rubello, Domenico
AU  - Rubello D
AD  - Nuclear Medicine Unit, Santa Maria della Misericordia Hospital, Rovigo, Italy. 
      Electronic address: domenico.rubello@libero.it.
LA  - eng
GR  - P20 GM103542/GM/NIGMS NIH HHS/United States
PT  - Journal Article
DEP - 20200821
PL  - France
TA  - Biomed Pharmacother
JT  - Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie
JID - 8213295
RN  - 0 (Aminobutyrates)
RN  - 0 (Biphenyl Compounds)
RN  - 0 (Drug Combinations)
RN  - 80M03YXJ7I (Valsartan)
RN  - WB8FT61183 (sacubitril and valsartan sodium hydrate drug combination)
SB  - IM
MH  - Aged
MH  - Aminobutyrates/administration & dosage/adverse effects/*therapeutic use
MH  - Biphenyl Compounds/administration & dosage/adverse effects/*therapeutic use
MH  - Chronic Disease
MH  - Clinical Studies as Topic
MH  - Drug Combinations
MH  - Female
MH  - Heart Failure/diagnosis/*drug therapy/etiology/*physiopathology
MH  - Humans
MH  - Hypertension/complications
MH  - Male
MH  - Patient Readmission
MH  - Prognosis
MH  - Severity of Illness Index
MH  - Stroke Volume/*drug effects
MH  - Treatment Outcome
MH  - Valsartan/administration & dosage/adverse effects/*therapeutic use
MH  - Ventricular Dysfunction, Left/drug therapy
PMC - PMC8963534
MID - NIHMS1742441
OTO - NOTNLM
OT  - Chronic heart failure
OT  - Ejection fraction
OT  - Hypertension
OT  - Internal medicine
OT  - Mortality
OT  - Sacubitril/valsartan
COIS- Declaration of Competing Interest The authors declare that there are no conflicts 
      of interest.
EDAT- 2021/07/30 06:00
MHDA- 2021/08/13 06:00
PMCR- 2022/03/29
CRDT- 2021/07/29 05:44
PHST- 2020/04/16 00:00 [received]
PHST- 2020/07/13 00:00 [revised]
PHST- 2020/07/28 00:00 [accepted]
PHST- 2021/07/29 05:44 [entrez]
PHST- 2021/07/30 06:00 [pubmed]
PHST- 2021/08/13 06:00 [medline]
PHST- 2022/03/29 00:00 [pmc-release]
AID - S0753-3322(20)30789-7 [pii]
AID - 10.1016/j.biopha.2020.110596 [doi]
PST - ppublish
SO  - Biomed Pharmacother. 2020 Oct;130:110596. doi: 10.1016/j.biopha.2020.110596. Epub 
      2020 Aug 21.