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The safety of sacubitril-valsartan for the treatment of chronic heart failure.

Abstract Sacubitril-valsartan is a combination drug that contains the neprilysin inhibitor sacubitril and angiotensin II receptor blocker valsartan. In 2015, the US Food and Drug Administration approved sacubitril-valsartan for treatment of heart failure patients with reduced ejection fraction and New York Heart Association class II-IV symptoms following a large, Phase III clinical trial (PARADIGM-HF) that demonstrated a 20% reduction in the combined primary end-point of death from cardiovascular cause or hospitalization for heart failure compared to enalapril. Areas covered: This review discusses the clinical efficacy and safety of angiotensin receptor neprilysin inhibitor sacubitril-valsartan in heart failure with reduced ejection fraction. Expert opinion: Based on the PARADIGM-HF trial, sacubitril-valsartan offers compelling reductions in meaningful clinical endpoints, independent of age or severity of disease. The rate of adverse events was comparable between the enalapril and sacubitril-valsartan groups, although the absolute rates are likely underestimated due to the entry criteria and run-in period. Future trials and post-market surveillance are critical to better understand the risk of angioedema in high risk populations, particularly African-Americans, as well as long-term theoretical risks including the potential for increased cerebral amyloid plaque deposition with possible development of neurocognitive disease. Current trials are underway to evaluate potential benefit in patients with heart failure with preserved ejection fraction.
PMID
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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

Cardiomyopathy

LCZ696

drug combination

drug safety

heart failure

pharmacology

sacubitril-valsartan

Journal Title expert opinion on drug safety
Publication Year Start




PMID- 28060547
OWN - NLM
STAT- In-Process
DA  - 20170106
LR  - 20170125
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 16
IP  - 2
DP  - 2017 Feb
TI  - The safety of sacubitril-valsartan for the treatment of chronic heart failure.
PG  - 257-263
LID - 10.1080/14740338.2017.1279144 [doi]
AB  - INTRODUCTION: Sacubitril-valsartan is a combination drug that contains the
      neprilysin inhibitor sacubitril and angiotensin II receptor blocker valsartan. In
      2015, the US Food and Drug Administration approved sacubitril-valsartan for
      treatment of heart failure patients with reduced ejection fraction and New York
      Heart Association class II-IV symptoms following a large, Phase III clinical
      trial (PARADIGM-HF) that demonstrated a 20% reduction in the combined primary
      end-point of death from cardiovascular cause or hospitalization for heart failure
      compared to enalapril. Areas covered: This review discusses the clinical efficacy
      and safety of angiotensin receptor neprilysin inhibitor sacubitril-valsartan in
      heart failure with reduced ejection fraction. Expert opinion: Based on the
      PARADIGM-HF trial, sacubitril-valsartan offers compelling reductions in
      meaningful clinical endpoints, independent of age or severity of disease. The
      rate of adverse events was comparable between the enalapril and
      sacubitril-valsartan groups, although the absolute rates are likely
      underestimated due to the entry criteria and run-in period. Future trials and
      post-market surveillance are critical to better understand the risk of angioedema
      in high risk populations, particularly African-Americans, as well as long-term
      theoretical risks including the potential for increased cerebral amyloid plaque
      deposition with possible development of neurocognitive disease. Current trials
      are underway to evaluate potential benefit in patients with heart failure with
      preserved ejection fraction.
FAU - Tyler, Jeffrey M
AU  - Tyler JM
AD  - a School of Medicine , University of California San Francisco , San Francisco ,
      CA , USA.
FAU - Teerlink, John R
AU  - Teerlink JR
AD  - a School of Medicine , University of California San Francisco , San Francisco ,
      CA , USA.
AD  - b Section of Cardiology , San Francisco Veterans Affairs Medical Center , San
      Francisco , CA , USA.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
OTO - NOTNLM
OT  - Cardiomyopathy
OT  - LCZ696
OT  - drug combination
OT  - drug safety
OT  - heart failure
OT  - pharmacology
OT  - sacubitril-valsartan
EDAT- 2017/01/07 06:00
MHDA- 2017/01/07 06:00
CRDT- 2017/01/07 06:00
AID - 10.1080/14740338.2017.1279144 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2017 Feb;16(2):257-263. doi: 10.1080/14740338.2017.1279144.

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