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Efficacy and safety of sacubitril/valsartan (LCZ696) in Japanese patients with chronic heart failure and reduced ejection fraction: Rationale for and design of the randomized, double-blind PARALLEL-HF study.

Abstract The prognosis of heart failure patients with reduced ejection fraction (HFrEF) in Japan remains poor, although there is growing evidence for increasing use of evidence-based pharmacotherapies in Japanese real-world HF registries. Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin receptor neprilysin inhibitor shown to reduce mortality and morbidity in the recently completed largest outcome trial in patients with HFrEF (PARADIGM-HF trial). The prospectively designed phase III PARALLEL-HF (Prospective comparison of ARNI with ACE inhibitor to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients) study aims to assess the clinical efficacy and safety of LCZ696 in Japanese HFrEF patients, and show similar improvements in clinical outcomes as the PARADIGM-HF study enabling the registration of LCZ696 in Japan.
PMID
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Sacubitril/Valsartan (LCZ696) in Heart Failure.

Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF).

Influence of Ejection Fraction on Outcomes and Efficacy of Sacubitril/Valsartan (LCZ696) in Heart Failure with Reduced Ejection Fraction: The Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) Trial.

Authors

Mayor MeshTerms
Keywords

Heart failure with reduced ejection fraction

Japanese

LCZ696

Neprilysin

Sacubitril/valsartan

Journal Title journal of cardiology
Publication Year Start




PMID- 28024961
OWN - NLM
STAT- Publisher
DA  - 20161227
LR  - 20161228
IS  - 1876-4738 (Electronic)
IS  - 0914-5087 (Linking)
DP  - 2016 Dec 23
TI  - Efficacy and safety of sacubitril/valsartan (LCZ696) in Japanese patients with
      chronic heart failure and reduced ejection fraction: Rationale for and design of 
      the randomized, double-blind PARALLEL-HF study.
LID - S0914-5087(16)30309-4 [pii]
LID - 10.1016/j.jjcc.2016.11.011 [doi]
AB  - BACKGROUND: The prognosis of heart failure patients with reduced ejection
      fraction (HFrEF) in Japan remains poor, although there is growing evidence for
      increasing use of evidence-based pharmacotherapies in Japanese real-world HF
      registries. Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin
      receptor neprilysin inhibitor shown to reduce mortality and morbidity in the
      recently completed largest outcome trial in patients with HFrEF (PARADIGM-HF
      trial). The prospectively designed phase III PARALLEL-HF (Prospective comparison 
      of ARNI with ACE inhibitor to determine the noveL beneficiaL trEatment vaLue in
      Japanese Heart Failure patients) study aims to assess the clinical efficacy and
      safety of LCZ696 in Japanese HFrEF patients, and show similar improvements in
      clinical outcomes as the PARADIGM-HF study enabling the registration of LCZ696 in
      Japan. METHODS AND DESIGN: This is a multicenter, randomized, double-blind,
      parallel-group, active controlled study of 220 Japanese HFrEF patients.
      Eligibility criteria include a diagnosis of chronic HF (New York Heart
      Association Class II-IV) and reduced ejection fraction (left ventricular ejection
      fraction </=35%) and increased plasma concentrations of natriuretic peptides
      [N-terminal pro B-type natriuretic peptide (NT-proBNP) >/=600pg/mL, or NT-proBNP 
      >/=400pg/mL for those who had a hospitalization for HF within the last 12 months]
      at the screening visit. The study consists of three phases: (i) screening, (ii)
      single-blind active LCZ696 run-in, and (iii) double-blind randomized treatment.
      Patients tolerating LCZ696 50mg bid during the treatment run-in are randomized
      (1:1) to receive LCZ696 100mg bid or enalapril 5mg bid for 4 weeks followed by
      up-titration to target doses of LCZ696 200mg bid or enalapril 10mg bid in a
      double-blind manner. The primary outcome is the composite of cardiovascular death
      or HF hospitalization and the study is an event-driven trial. CONCLUSIONS: The
      design of the PARALLEL-HF study is aligned with the PARADIGM-HF study and aims to
      assess the efficacy and safety of LCZ696 in Japanese HFrEF patients.
CI  - Copyright (c) 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Tsutsui, Hiroyuki
AU  - Tsutsui H
AD  - Department of Cardiovascular Medicine, Kyushu University, Fukuoka, Japan.
      Electronic address: [email protected]
FAU - Momomura, Shinichi
AU  - Momomura S
AD  - Cardiovascular Division, Jichi Medical University, Saitama Medical Center,
      Saitama, Japan.
FAU - Saito, Yoshihiko
AU  - Saito Y
AD  - First Department of Internal Medicine, Nara Medical University, Kashihara, Japan.
FAU - Ito, Hiroshi
AU  - Ito H
AD  - Department of Cardiovascular Medicine, Okayama University Graduate School of
      Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
FAU - Yamamoto, Kazuhiro
AU  - Yamamoto K
AD  - Department of Molecular Medicine and Therapeutics, Tottori University, Yonago,
      Japan.
FAU - Ohishi, Tomomi
AU  - Ohishi T
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Okino, Naoko
AU  - Okino N
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Guo, Weinong
AU  - Guo W
AD  - Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.
LA  - eng
PT  - Journal Article
DEP - 20161223
PL  - Netherlands
TA  - J Cardiol
JT  - Journal of cardiology
JID - 8804703
OTO - NOTNLM
OT  - Heart failure with reduced ejection fraction
OT  - Japanese
OT  - LCZ696
OT  - Neprilysin
OT  - Sacubitril/valsartan
EDAT- 2016/12/28 06:00
MHDA- 2016/12/28 06:00
CRDT- 2016/12/28 06:00
PHST- 2016/07/22 [received]
PHST- 2016/10/14 [revised]
PHST- 2016/11/02 [accepted]
AID - S0914-5087(16)30309-4 [pii]
AID - 10.1016/j.jjcc.2016.11.011 [doi]
PST - aheadofprint
SO  - J Cardiol. 2016 Dec 23. pii: S0914-5087(16)30309-4. doi:
      10.1016/j.jjcc.2016.11.011.

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