PMID- 33731544
OWN - NLM
STAT- MEDLINE
DCOM- 20220215
LR  - 20220215
IS  - 1347-4820 (Electronic)
IS  - 1346-9843 (Linking)
VI  - 85
IP  - 5
DP  - 2021 Apr 23
TI  - Efficacy and Safety of Sacubitril/Valsartan in Japanese Patients With Chronic 
      Heart Failure and Reduced Ejection Fraction　- Results From the PARALLEL-HF Study.
PG  - 584-594
LID - 10.1253/circj.CJ-20-0854 [doi]
AB  - BACKGROUND: In the Prospective Comparison of angiotensin receptor neprilysin 
      inhibitor (ARNI) With ACEi to Determine Impact on Global Mortality and Morbidity 
      in Heart Failure (PARADIGM-HF) study, treatment with sacubitril/valsartan reduced 
      the primary outcome of cardiovascular (CV) death and heart failure (HF) 
      hospitalization compared with enalapril in patients with chronic HF and reduced 
      ejection fraction (HFrEF). A prospective randomized trial was conducted to assess 
      the efficacy and safety of sacubitril/valsartan in Japanese HFrEF 
      patients.Methods and Results:In the Prospective comparison of ARNI with ACEi to 
      determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients 
      (PARALLEL-HF) study, 225 Japanese HFrEF patients (New York Heart Association 
      [NYHA] class II-IV, left ventricular ejection fraction [LVEF] </=35%) were 
      randomized (1 : 1) to receive sacubitril/valsartan 200 mg bid or enalapril 10 mg 
      bid. Over a median follow up of 33.9 months, no significant between-group 
      difference was observed for the primary composite outcome of CV death and HF 
      hospitalization (HR 1.09; 95% CI 0.65-1.82; P=0.6260). Early and sustained 
      reductions in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline 
      were observed with sacubitril/valsartan compared with enalapril (between-group 
      difference: Week 2: 25.7%, P<0.01; Month 6: 18.9%, P=0.01, favoring 
      sacubitril/valsartan). There was no significant difference in the changes in NYHA 
      class and Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score 
      at Week 8 and Month 6. Sacubitril/valsartan was well tolerated with fewer study 
      drug discontinuations due to adverse events, although the sacubitril/valsartan 
      group had a higher proportion of patients with hypotension. CONCLUSIONS: In 
      Japanese patients with HFrEF, there was no difference in reduction in the risk of 
      CV death or HF hospitalization between sacubitril/valsartan and enalapril, and 
      sacubitril/valsartan was safe and well tolerated.
FAU - Tsutsui, Hiroyuki
AU  - Tsutsui H
AD  - Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu 
      University.
FAU - Momomura, Shin-Ichi
AU  - Momomura SI
AD  - Saitama Citizens Medical Center.
FAU - Saito, Yoshihiko
AU  - Saito Y
AD  - Department of Cardiovascular Medicine, Nara Medical University.
FAU - Ito, Hiroshi
AU  - Ito H
AD  - Department of Cardiovascular Medicine, Okayama University Graduate School of 
      Medicine, Dentistry and Pharmaceutical Sciences.
FAU - Yamamoto, Kazuhiro
AU  - Yamamoto K
AD  - Department of Cardiovascular Medicine and Endocrinology and Metabolism, Tottori 
      University.
FAU - Sakata, Yasushi
AU  - Sakata Y
AD  - Department of Cardiovascular Medicine, Osaka University Graduate School of 
      Medicine.
FAU - Desai, Akshay Suvas
AU  - Desai AS
AD  - Cardiovascular Division, Brigham and Women's Hospital.
FAU - Ohishi, Tomomi
AU  - Ohishi T
AD  - Novartis Pharma K.K.
FAU - Iimori, Takayuki
AU  - Iimori T
AD  - Novartis Pharma K.K.
FAU - Kitamura, Toshihito
AU  - Kitamura T
AD  - Novartis Pharma K.K.
FAU - Guo, Weinong
AU  - Guo W
AD  - Novartis Pharmaceutical Corporation.
CN  - PARALLEL-HF Investigators
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210316
PL  - Japan
TA  - Circ J
JT  - Circulation journal : official journal of the Japanese Circulation Society
JID - 101137683
RN  - 0 (Aminobutyrates)
RN  - 0 (Angiotensin Receptor Antagonists)
RN  - 0 (Biphenyl Compounds)
RN  - 0 (Drug Combinations)
RN  - 0 (Tetrazoles)
RN  - 17ERJ0MKGI (sacubitril)
RN  - 69PN84IO1A (Enalapril)
RN  - 80M03YXJ7I (Valsartan)
SB  - IM
MH  - Aminobutyrates/adverse effects
MH  - Angiotensin Receptor Antagonists/adverse effects
MH  - Biphenyl Compounds
MH  - Drug Combinations
MH  - Enalapril/adverse effects
MH  - *Heart Failure/drug therapy
MH  - Humans
MH  - Japan
MH  - Prospective Studies
MH  - Stroke Volume
MH  - Tetrazoles/adverse effects
MH  - Treatment Outcome
MH  - Valsartan
MH  - *Ventricular Dysfunction, Left
MH  - Ventricular Function, Left
OTO - NOTNLM
OT  - Efficacy
OT  - HFrEF
OT  - Japanese
OT  - PARALLEL-HF
OT  - Sacubitril/Valsartan
EDAT- 2021/03/19 06:00
MHDA- 2022/02/16 06:00
CRDT- 2021/03/18 06:13
PHST- 2021/03/19 06:00 [pubmed]
PHST- 2022/02/16 06:00 [medline]
PHST- 2021/03/18 06:13 [entrez]
AID - 10.1253/circj.CJ-20-0854 [doi]
PST - ppublish
SO  - Circ J. 2021 Apr 23;85(5):584-594. doi: 10.1253/circj.CJ-20-0854. Epub 2021 Mar 
      16.