PMID- 33545266
OWN - NLM
STAT- MEDLINE
DCOM- 20210528
LR  - 20211124
IS  - 1874-1754 (Electronic)
IS  - 0167-5273 (Linking)
VI  - 331
DP  - 2021 May 15
TI  - Real-world effectiveness and safety of sacubitril/valsartan in heart failure: A 
      systematic review.
PG  - 164-171
LID - S0167-5273(21)00143-1 [pii]
LID - 10.1016/j.ijcard.2021.01.061 [doi]
AB  - BACKGROUND: PARADIGM-HF demonstrated superiority of sacubitril/valsartan 
      (sac/val) over enalapril in patients with heart failure with reduced ejection 
      fraction (HFrEF). However, patients in clinical practice may differ in their 
      characteristics and overall risk compared with patients in clinical trials, and 
      additional outcomes can be observed in real world (RW). Hence, a systematic 
      review was conducted to identify and describe RW data on sac/val. METHODS: RW 
      studies evaluating the effects of sac/val in adult patients with HFrEF with a 
      sample size >/=100 were identified via MEDLINE(R) and Embase(R) from 2015 to January 
      2020. Citations were screened, critically appraised and relevant data were 
      extracted. RESULTS: A total of 68 unique studies were identified. Nearly half of 
      the studies were conducted in Europe (n = 34), followed by the US (n = 15) and 
      Asia (n = 11). Median follow-up period varied from 1 to 19 months. Mean age 
      ranged between 48.7 and 79.0 years; patients were mostly male and in New York 
      Heart Association (NYHA) functional class II/III, and mean left ventricular 
      ejection fraction varied between 23%and 38%. Of studies performing comparisons, 
      most reported superior efficacy of sac/val in reducing the risk of HF 
      hospitalisations, all-cause hospitalisations, and all-cause mortality as compared 
      to standard-of-care. Many studies reported significant improvements in NYHA 
      functional class and reduction in biomarker levels post sac/val. Hypotension and 
      hyperkalaemia were the most frequently reported adverse events. CONCLUSIONS: This 
      comprehensive overview of currently available RW evidence on sac/val complements 
      the evidence from randomised controlled trials, substantiating its effectiveness 
      in heterogeneous real-world HF populations.
CI  - Copyright (c) 2021 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Proudfoot, Clare
AU  - Proudfoot C
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Studer, Rachel
AU  - Studer R
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Rajput, Tanvi
AU  - Rajput T
AD  - Novartis Healthcare Pvt Ltd., Hyderabad, India.
FAU - Jindal, Ramandeep
AU  - Jindal R
AD  - Novartis Healthcare Pvt Ltd., Hyderabad, India.
FAU - Agrawal, Rumjhum
AU  - Agrawal R
AD  - Novartis Healthcare Pvt Ltd., Hyderabad, India.
FAU - Corda, Stefano
AU  - Corda S
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Senni, Michele
AU  - Senni M
AD  - Cardiology Division, Cardiovascular Department, Ospedale Papa Giovanni XXIII, 
      Bergamo, Italy. Electronic address: msenni@asst-pg23.it.
LA  - eng
PT  - Journal Article
PT  - Systematic Review
DEP - 20210203
PL  - Netherlands
TA  - Int J Cardiol
JT  - International journal of cardiology
JID - 8200291
RN  - 0 (Aminobutyrates)
RN  - 0 (Angiotensin Receptor Antagonists)
RN  - 0 (Biphenyl Compounds)
RN  - 0 (Drug Combinations)
RN  - 0 (Tetrazoles)
RN  - 80M03YXJ7I (Valsartan)
RN  - WB8FT61183 (sacubitril and valsartan sodium hydrate drug combination)
SB  - IM
CIN - Int J Cardiol. 2021 Dec 15;345:107-108. PMID: 34688720
MH  - Aged
MH  - Aminobutyrates/adverse effects
MH  - Angiotensin Receptor Antagonists/adverse effects
MH  - Asia
MH  - Biphenyl Compounds
MH  - Drug Combinations
MH  - Europe
MH  - Female
MH  - *Heart Failure/diagnosis/drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Stroke Volume
MH  - Tetrazoles/adverse effects
MH  - Valsartan
MH  - Ventricular Function, Left
OTO - NOTNLM
OT  - Clinical effectiveness
OT  - HFrEF
OT  - Real world
OT  - Sacubitril/valsartan
OT  - Safety
COIS- Declaration of competing interest The authors report no additional relationships 
      that could be construed as a conflict of interest Michele Senni is the Chief of 
      Cardiovascular Department and Cardiology 1, Unit ASST Papa Giovanni XXIII 
      hospital, Bergamo, Italy and declares financial interest for consultancy with 
      Novartis, Merck, Bayer, Vifor Pharma, Abbott, Boehringer Ingelheim, AstraZeneca, 
      and Servier. Clare Proudfoot, Rachel Studer and Stefano Corda are employees and 
      stockholders in Novartis Pharma AG. Tanvi Rajput, Ramandeep Jindal and Rumjhum 
      Agrawal are employees of Novartis Healthcare Pvt. Ltd. This study was funded by 
      Novartis Pharma AG.
EDAT- 2021/02/06 06:00
MHDA- 2021/05/29 06:00
CRDT- 2021/02/05 20:10
PHST- 2020/10/20 00:00 [received]
PHST- 2021/01/04 00:00 [revised]
PHST- 2021/01/25 00:00 [accepted]
PHST- 2021/02/06 06:00 [pubmed]
PHST- 2021/05/29 06:00 [medline]
PHST- 2021/02/05 20:10 [entrez]
AID - S0167-5273(21)00143-1 [pii]
AID - 10.1016/j.ijcard.2021.01.061 [doi]
PST - ppublish
SO  - Int J Cardiol. 2021 May 15;331:164-171. doi: 10.1016/j.ijcard.2021.01.061. Epub 
      2021 Feb 3.