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Drug Safety Evaluation

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

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Pages 257-263 | Received 03 Jul 2016, Accepted 03 Jan 2017, Published online: 25 Jan 2017

References

  • Reed BN, Street SE, Jensen BC. Time and technology will tell: the pathophysiologic basis of neurohormonal modulation in heart failure. Heart Fail Clin. 2014 Oct;10(4):543–557.
  • Levin ER, Gardner DG, Samson WK. Natriuretic peptides. N Engl J Med. 1998 Jul 30;339(5):321–328.
  • Pandey KN. Emerging roles of natriuretic peptides and their receptors in pathophysiology of hypertension and cardiovascular regulation. J Am Soc Hypertens. 2008 Jul-Aug;2(4):210–226.
  • McMurray JJ. Neprilysin inhibition to treat heart failure: a tale of science, serendipity, and second chances. Eur J Heart Fail. 2015 Mar;17(3):242–247.
  • de Bold AJ, Raymond JJ, Bencosme SA. Atrial specific granules of the rat heart: light microscopic staining and histochemical reactions. J Histochem Cytochem. 1978 Dec;26(12):1094–1102.
  • Mukoyama M, Nakao K, Hosoda K, et al. Brain natriuretic peptide as a novel cardiac hormone in humans. Evidence for an exquisite dual natriuretic peptide system, atrial natriuretic peptide and brain natriuretic peptide. J Clin Invest. 1991 Apr;87(4):1402–1412.
  • Sudoh T, Kangawa K, Minamino N, et al. A new natriuretic peptide in porcine brain. Nature. 1988 Mar 3;332(6159):78–81.
  • Northridge DB, Jardine AG, Alabaster CT, et al. Effects of UK 69 578: a novel atriopeptidase inhibitor. Lancet. 1989 Sep 9;2(8663):591–593.
  • Bevan EG, Connell JM, Doyle J, et al. Candoxatril, a neutral endopeptidase inhibitor: efficacy and tolerability in essential hypertension. J Hypertens. 1992 Jul;10(7):607–613.
  • Ferro CJ, Spratt JC, Haynes WG, et al. Inhibition of neutral endopeptidase causes vasoconstriction of human resistance vessels in vivo. Circulation. 1998 Jun 16;97(23):2323–2330.
  • McDowell G, Coutie W, Shaw C, et al. The effect of the neutral endopeptidase inhibitor drug, candoxatril, on circulating levels of two of the most potent vasoactive peptides. Br J Clin Pharmacol. 1997 Mar;43(3):329–332.
  • Packer M, Califf RM, Konstam MA, et al. Comparison of omapatrilat and enalapril in patients with chronic heart failure: the omapatrilat versus enalapril randomized trial of utility in reducing events (OVERTURE). Circulation. 2002 Aug 20;106(8):920–926.
  • Kostis JB, Packer M, Black HR, et al. Omapatrilat and enalapril in patients with hypertension: the omapatrilat cardiovascular treatment vs. enalapril (OCTAVE) trial. Am J Hypertens. 2004 Feb;17(2):103–111.
  • Hegde LG, Yu C, Renner T, et al. Concomitant angiotensin AT1 receptor antagonism and neprilysin inhibition produces omapatrilat-like antihypertensive effects without promoting tracheal plasma extravasation in the rat. J Cardiovasc Pharmacol. 2011 Apr;57(4):495–504.
  • Gu J, Noe A, Chandra P, et al. Pharmacokinetics and pharmacodynamics of LCZ696, a novel dual-acting angiotensin receptor-neprilysin inhibitor (ARNi). J Clin Pharmacol. 2010 Apr;50(4):401–414.
  • Sonnenberg JL, Sakane Y, Jeng AY, et al. Identification of protease 3.4.24.11 as the major atrial natriuretic factor degrading enzyme in the rat kidney. Peptides. 1988 Jan-Feb;9(1):173–180.
  • Mangiafico S, Costello-Boerrigter LC, Andersen IA, et al. Neutral endopeptidase inhibition and the natriuretic peptide system: an evolving strategy in cardiovascular therapeutics. Eur Heart J. 2013 Mar;34(12):886–93c.
  • von Lueder TG, Wang BH, Kompa AR, et al. Angiotensin receptor neprilysin inhibitor LCZ696 attenuates cardiac remodeling and dysfunction after myocardial infarction by reducing cardiac fibrosis and hypertrophy. Circ Heart Fail. 2015 Jan;8(1):71–78.
  • Wang BH, von Lueder TG, Kompa AR, et al. Combined angiotensin receptor blockade and neprilysin inhibition attenuates angiotensin-II mediated renal cellular collagen synthesis. Int J Cardiol. 2015;186:104–105.
  • Solomon SD, Zile M, Pieske B, et al. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a phase 2 double-blind randomised controlled trial. Lancet. 2012 Oct 20;380(9851):1387–1395.
  • McMurray JJV, Packer M, Desai AS, et al. Angiotensin–neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993–1004.
  • Packer M, McMurray JJ, Desai AS, et al. Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Circulation. 2015 Jan 6;131(1):54–61.
  • Jhund PS, Fu M, Bayram E, et al. Efficacy and safety of LCZ696 (sacubitril-valsartan) according to age: insights from PARADIGM-HF. Eur Heart J. 2015 Oct 7;36(38):2576–2584.
  • Desai AS, McMurray JJ, Packer M, et al. Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients. Eur Heart J. 2015 Aug 7;36(30):1990–1997.
  • Vardeny O, Claggett B, Packer M, et al. Efficacy of sacubitril/valsartan vs. enalapril at lower than target doses in heart failure with reduced ejection fraction: the PARADIGM-HF trial. Eur J Heart Fail. 2016 Oct;18(10):1228–1234.
  • Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129–2200.
  • Yancy CW, Jessup M, Bozkurt B, et al. 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: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2016 Sep 27;68(13):1476–1488.
  • The SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. The SOLVD investigators. N Engl J Med. 1991 Aug 1;325(5):293–302.
  • Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. New England J Med. 1996;334(21):1349–1355.
  • Unger EF. Sacubitril-Valsartan NDA Approval Letter: Food and Drug Administration; 2015 07/Jul/2015. [cited 2017 Jan 19]. Available from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207620Orig1s000ltr.pdf
  • Miners JS, Kehoe P, Love S. Neprilysin protects against cerebral amyloid angiopathy and abeta-induced degeneration of cerebrovascular smooth muscle cells. Brain Pathol. 2011 Sep;21(5):594–605.
  • Vodovar N, Paquet C, Mebazaa A, et al. Neprilysin, cardiovascular, and Alzheimer’s diseases: the therapeutic split? Eur Heart J. 2015 Apr 14; 36(15):902–905.
  • Iwata N, Tsubuki S, Takaki Y, et al. Identification of the major Abeta1-42-degrading catabolic pathway in brain parenchyma: suppression leads to biochemical and pathological deposition. Nat Med. 2000 Feb;6(2):143–150.
  • Yasojima K, Akiyama H, McGeer EG, et al. Reduced neprilysin in high plaque areas of Alzheimer brain: a possible relationship to deficient degradation of beta-amyloid peptide. Neurosci Lett. 2001 Jan 12;297(2):97–100.
  • Yasojima K, McGeer EG, McGeer PL. Relationship between beta amyloid peptide generating molecules and neprilysin in Alzheimer disease and normal brain. Brain Res. 2001 Nov 16;919(1):115–121.
  • Newell AJ, Sue LI, Scott S, et al. Thiorphan-induced neprilysin inhibition raises amyloid beta levels in rabbit cortex and cerebrospinal fluid. Neurosci Lett. 2003 Oct 30;350(3):178–180.
  • Vepsalainen S, Helisalmi S, Mannermaa A, et al. Combined risk effects of IDE and NEP gene variants on Alzheimer disease. J Neurol Neurosurg Psychiatry. 2009 Nov;80(11):1268–1270.
  • Feldman AM, Haller JA, DeKosky ST. Valsartan/sacubitril for heart failure: reconciling disparities between preclinical and clinical investigations. JAMA. 2016 Jan 05;315(1):25–26.
  • McMurray JJ, Packer M, Solomon SD. Neprilysin inhibition for heart failure. New England J Med. 2014;371(24):2335–2337.
  • Langenickel TH, Tsubouchi C, Ayalasomayajula S, et al. The effect of LCZ696 (sacubitril/valsartan) on amyloid-beta concentrations in cerebrospinal fluid in healthy subjects. Br J Clin Pharmacol. 2016 May;81(5):878–890.
  • Villapol S, Saavedra JM. Neuroprotective effects of angiotensin receptor blockers. Am J Hypertens. 2015 Mar;28(3):289–299.
  • Hemming ML, Selkoe DJ, Farris W. Effects of prolonged angiotensin-converting enzyme inhibitor treatment on amyloid beta-protein metabolism in mouse models of Alzheimer disease. Neurobiol Dis. 2007 Apr;26(1):273–281.
  • Ohno-Matsui K. Parallel findings in age-related macular degeneration and Alzheimer’s disease. Prog Retin Eye Res. 2011 Jul;30(4):217–238.
  • Claggett B, Packer M, McMurray JJ, et al. Estimating the long-term treatment benefits of sacubitril-valsartan. N Engl J Med. 2015 Dec 3;373(23):2289–2290.
  • Chin MH, Wang JC, Zhang JX, et al. Utilization and dosing of angiotensin-converting enzyme inhibitors for heart failure. Effect of physician specialty and patient characteristics. J Gen Intern Med. 1997 Sep;12(9):563–566.
  • Peters-Klimm F, Muller-Tasch T, Remppis A, et al. Improved guideline adherence to pharmacotherapy of chronic systolic heart failure in general practice–results from a cluster-randomized controlled trial of implementation of a clinical practice guideline. J Eval Clin Pract. 2008 Oct;14(5):823–829.
  • Konstam MA, Neaton JD, Dickstein K, et al. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet. 2009 Nov 28;374(9704):1840–1848.
  • Packer M, Poole-Wilson PA, Armstrong PW, et al. Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. ATLAS Study Group. Circulation. 1999 Dec 7;100(23):2312–2318.

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