Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm

Kathleen Lisa Morris; Edward Shmukler; Ann Schmit; Sunit Preet Chaudhry; Mary Norine Walsh; Ashwin Ravichandran

doi:doi:10.11648/j.ajim.20180604.11

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Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm

Kathleen Lisa Morris, Edward Shmukler, Ann Schmit, Sunit Preet Chaudhry, Mary Norine Walsh, Ashwin Ravichandran

Published in American Journal of Internal Medicine (Volume 6, Issue 4)

Received: 15 April 2018 Accepted: 12 June 2018 Published: 6 July 2018

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Abstract

PARADIGM-HF compared valsartan/sacubitril (ARNI) with enalapril in symptomatic patients with heart failure with reduced ejection fraction (HFrEF) (1). It was stopped early after the boundary for overwhelming benefit in favor of ARNI had been reached. Patients taking ARNI had decreased symptoms, risk of HF hospitalization and all-cause and cardiovascular mortality. We sought to describe our center’s initial year of experience with this novel agent. A retrospective chart review was completed of all patients in our advanced HF clinic who were prescribed ARNI between August 2015 and October 2016. Outcomes data were collected through August 2017. Consistent with the Food and Drug Administration (FDA) indication, patients treated had NYHA class II, III or IV HF symptoms with LVEF of 35% or less. The majority of those prescribed ARNI were able to initiate the medication. However, a significant proportion of patients (26.4%) had to discontinue ARNI due to a variety of reasons, most commonly symptomatic hypotension (31.0%) and insufficient insurance coverage (31.0%). Only 30.5% of patients successfully treated reached the maximum dose; in 85% of these patients, hypotension limited up titration of therapy. PARADIGM-HF demonstrated benefit of ARNI therapy over enalapril in patients with HFrEF and therapy was well tolerated. In our real world experience, hypotension and lack of insurance coverage limited utilization. Further experience with this therapy in a non-trial setting will inform optimal patient selection and titration strategies. Expanded insurance coverage will be crucial to allow for patient access.

Published in	American Journal of Internal Medicine (Volume 6, Issue 4)
DOI	10.11648/j.ajim.20180604.11
Page(s)	52-55
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2018. Published by Science Publishing Group

Keywords

Cardiology, Heart Failure, Medications

References

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[2]	CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure, results of the cooperative north Scandinavian enalapril survival study. N Engl J Med 1987; 316(23):1429-35.
[3]	Packer M, et al. Effect of Carvedilol on the Morbidity of Patients with Severe Chronic Heart Failure. Circ 2002; 106 (17): 2194-9.
[4]	Lechat P, et al. A randomized trial of beta-blockade in heart failure. The Cardiac Insufficiency Bisoprolol Study (CIBIS). Circ 1994; 90 (4): 1765-1773.
[5]	Fagerberg, B, et al. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure. Lancet 1999; 353 (9169): 2001-7.
[6]	Poole-Wilson PA, et al. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in Carvedilol or Metoprolol European trial. Lancet 2003; 362 (9377): 7-13.
[7]	Swedberg K et al Eplerenone and atrial fibrillation in mild systolic heart failure: results from the EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization And Survival Study in Heart Failure) study. J Am Coll Cardiol 2012; 59(18):1598-603.
[8]	Pitt B, et al. The EPHESUS trial: eplerenone in patients with heart failure due to systolic dysfunction complicating acute myocardial infarction. Eplerenone Post-AMI Heart Failure Efficacy and Survival Study. N Engl J Med 2003; 348:1309-21.
[9]	Pitt B, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. New Engl J Med 1999; 341(10):709-17.
[10]	Taylor AL, et al. Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure. New Engl J Med 2004; 351(20):2049-57.
[11]	Abraham WT, et al. Cardiac Resynchronization in Chronic Heart Failure. New Engl J Med 2002; 345: 1845-53.
[12]	Cleland, et al. The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure. New Engl J Med 2005; 352: 1539-49.
[13]	Moss AJ, et al. Cardiac-Resynchronization therapy for the prevention of heart failure events. New Engl J Med 2009; 361 (14):1329-1338.
[14]	Farmakis D, et al. Practical considerations on the introduction of sacubitril/valsartan in clinical practice: Current evidence and early experience. Int J Cardiol 2016; 223: 781-84.
[15]	Kobalava ZhD, et al. First Experience of Clinical Application of LCZ696—an AT1-angiotensin Receptors and Neprilysin Inhibitor—in Patients with Chronic Heart Failure and Reduced Ejection Fraction. Kardiologiia. 2015; 55: 14-25.
[16]	Juurlink DN, et al. Rates of Hyperkalemia after Publication of the Randomized Aldactone Evaluation Study. New Engl J Med 2004; 351: 543-51.
[17]	Yancy CW, et al. 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart. Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart. Failure. J Am Coll Cardiol 2016; 68 (11): 1476-88.

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Kathleen Lisa Morris, Edward Shmukler, Ann Schmit, Sunit Preet Chaudhry, Mary Norine Walsh, et al. (2018). Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm. American Journal of Internal Medicine, 6(4), 52-55. https://doi.org/10.11648/j.ajim.20180604.11

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ACS Style

Kathleen Lisa Morris; Edward Shmukler; Ann Schmit; Sunit Preet Chaudhry; Mary Norine Walsh, et al. Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm. Am. J. Intern. Med. 2018, 6(4), 52-55. doi: 10.11648/j.ajim.20180604.11

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AMA Style

Kathleen Lisa Morris, Edward Shmukler, Ann Schmit, Sunit Preet Chaudhry, Mary Norine Walsh, et al. Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm. Am J Intern Med. 2018;6(4):52-55. doi: 10.11648/j.ajim.20180604.11

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@article{10.11648/j.ajim.20180604.11,
  author = {Kathleen Lisa Morris and Edward Shmukler and Ann Schmit and Sunit Preet Chaudhry and Mary Norine Walsh and Ashwin Ravichandran},
  title = {Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm},
  journal = {American Journal of Internal Medicine},
  volume = {6},
  number = {4},
  pages = {52-55},
  doi = {10.11648/j.ajim.20180604.11},
  url = {https://doi.org/10.11648/j.ajim.20180604.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajim.20180604.11},
  abstract = {PARADIGM-HF compared valsartan/sacubitril (ARNI) with enalapril in symptomatic patients with heart failure with reduced ejection fraction (HFrEF) (1). It was stopped early after the boundary for overwhelming benefit in favor of ARNI had been reached. Patients taking ARNI had decreased symptoms, risk of HF hospitalization and all-cause and cardiovascular mortality. We sought to describe our center’s initial year of experience with this novel agent. A retrospective chart review was completed of all patients in our advanced HF clinic who were prescribed ARNI between August 2015 and October 2016. Outcomes data were collected through August 2017. Consistent with the Food and Drug Administration (FDA) indication, patients treated had NYHA class II, III or IV HF symptoms with LVEF of 35% or less. The majority of those prescribed ARNI were able to initiate the medication. However, a significant proportion of patients (26.4%) had to discontinue ARNI due to a variety of reasons, most commonly symptomatic hypotension (31.0%) and insufficient insurance coverage (31.0%). Only 30.5% of patients successfully treated reached the maximum dose; in 85% of these patients, hypotension limited up titration of therapy. PARADIGM-HF demonstrated benefit of ARNI therapy over enalapril in patients with HFrEF and therapy was well tolerated. In our real world experience, hypotension and lack of insurance coverage limited utilization. Further experience with this therapy in a non-trial setting will inform optimal patient selection and titration strategies. Expanded insurance coverage will be crucial to allow for patient access.},
 year = {2018}
}

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TY - JOUR
T1 - Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm
AU - Kathleen Lisa Morris
AU - Edward Shmukler
AU - Ann Schmit
AU - Sunit Preet Chaudhry
AU - Mary Norine Walsh
AU - Ashwin Ravichandran
Y1 - 2018/07/06
PY - 2018
N1 - https://doi.org/10.11648/j.ajim.20180604.11
DO - 10.11648/j.ajim.20180604.11
T2 - American Journal of Internal Medicine
JF - American Journal of Internal Medicine
JO - American Journal of Internal Medicine
SP - 52
EP - 55
PB - Science Publishing Group
SN - 2330-4324
UR - https://doi.org/10.11648/j.ajim.20180604.11
AB - PARADIGM-HF compared valsartan/sacubitril (ARNI) with enalapril in symptomatic patients with heart failure with reduced ejection fraction (HFrEF) (1). It was stopped early after the boundary for overwhelming benefit in favor of ARNI had been reached. Patients taking ARNI had decreased symptoms, risk of HF hospitalization and all-cause and cardiovascular mortality. We sought to describe our center’s initial year of experience with this novel agent. A retrospective chart review was completed of all patients in our advanced HF clinic who were prescribed ARNI between August 2015 and October 2016. Outcomes data were collected through August 2017. Consistent with the Food and Drug Administration (FDA) indication, patients treated had NYHA class II, III or IV HF symptoms with LVEF of 35% or less. The majority of those prescribed ARNI were able to initiate the medication. However, a significant proportion of patients (26.4%) had to discontinue ARNI due to a variety of reasons, most commonly symptomatic hypotension (31.0%) and insufficient insurance coverage (31.0%). Only 30.5% of patients successfully treated reached the maximum dose; in 85% of these patients, hypotension limited up titration of therapy. PARADIGM-HF demonstrated benefit of ARNI therapy over enalapril in patients with HFrEF and therapy was well tolerated. In our real world experience, hypotension and lack of insurance coverage limited utilization. Further experience with this therapy in a non-trial setting will inform optimal patient selection and titration strategies. Expanded insurance coverage will be crucial to allow for patient access.
VL - 6
IS - 4
ER -

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Author Information

Kathleen Lisa Morris

Department of Cardiology, St. Vincent Hospital and Heart Center, Indianapolis, USA
Edward Shmukler

Department of Cardiology, St. Vincent Hospital and Heart Center, Indianapolis, USA
Ann Schmit

Department of Advanced Heart Failure and Transplant, St. Vincent Hospital and Heart Center, Indianapolis, USA
Sunit Preet Chaudhry

Department of Advanced Heart Failure and Transplant, St. Vincent Hospital and Heart Center, Indianapolis, USA
Mary Norine Walsh

Department of Advanced Heart Failure and Transplant, St. Vincent Hospital and Heart Center, Indianapolis, USA
Ashwin Ravichandran

Department of Advanced Heart Failure and Transplant, St. Vincent Hospital and Heart Center, Indianapolis, USA

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Plain Text BibTeX RIS

APA Style

Kathleen Lisa Morris, Edward Shmukler, Ann Schmit, Sunit Preet Chaudhry, Mary Norine Walsh, et al. (2018). Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm. American Journal of Internal Medicine, 6(4), 52-55. https://doi.org/10.11648/j.ajim.20180604.11

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ACS Style

Kathleen Lisa Morris; Edward Shmukler; Ann Schmit; Sunit Preet Chaudhry; Mary Norine Walsh, et al. Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm. Am. J. Intern. Med. 2018, 6(4), 52-55. doi: 10.11648/j.ajim.20180604.11

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AMA Style

Kathleen Lisa Morris, Edward Shmukler, Ann Schmit, Sunit Preet Chaudhry, Mary Norine Walsh, et al. Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm. Am J Intern Med. 2018;6(4):52-55. doi: 10.11648/j.ajim.20180604.11

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@article{10.11648/j.ajim.20180604.11,
  author = {Kathleen Lisa Morris and Edward Shmukler and Ann Schmit and Sunit Preet Chaudhry and Mary Norine Walsh and Ashwin Ravichandran},
  title = {Valsartan/Sacubitril for Treatment of Hfref: A Single Center's Paradigm},
  journal = {American Journal of Internal Medicine},
  volume = {6},
  number = {4},
  pages = {52-55},
  doi = {10.11648/j.ajim.20180604.11},
  url = {https://doi.org/10.11648/j.ajim.20180604.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajim.20180604.11},
  abstract = {PARADIGM-HF compared valsartan/sacubitril (ARNI) with enalapril in symptomatic patients with heart failure with reduced ejection fraction (HFrEF) (1). It was stopped early after the boundary for overwhelming benefit in favor of ARNI had been reached. Patients taking ARNI had decreased symptoms, risk of HF hospitalization and all-cause and cardiovascular mortality. We sought to describe our center’s initial year of experience with this novel agent. A retrospective chart review was completed of all patients in our advanced HF clinic who were prescribed ARNI between August 2015 and October 2016. Outcomes data were collected through August 2017. Consistent with the Food and Drug Administration (FDA) indication, patients treated had NYHA class II, III or IV HF symptoms with LVEF of 35% or less. The majority of those prescribed ARNI were able to initiate the medication. However, a significant proportion of patients (26.4%) had to discontinue ARNI due to a variety of reasons, most commonly symptomatic hypotension (31.0%) and insufficient insurance coverage (31.0%). Only 30.5% of patients successfully treated reached the maximum dose; in 85% of these patients, hypotension limited up titration of therapy. PARADIGM-HF demonstrated benefit of ARNI therapy over enalapril in patients with HFrEF and therapy was well tolerated. In our real world experience, hypotension and lack of insurance coverage limited utilization. Further experience with this therapy in a non-trial setting will inform optimal patient selection and titration strategies. Expanded insurance coverage will be crucial to allow for patient access.},
 year = {2018}
}

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