365
Views
0
CrossRef citations to date
0
Altmetric
Drug Evaluation

Current Evidence of sacubitril/valsartan in the Treatment of Heart Failure With Reduced Ejection Fraction

, , , &
Pages 227-236 | Received 04 Jan 2020, Accepted 17 Feb 2020, Published online: 18 Mar 2020

References

  • Ponikowski P , AnkerSD, VoorsAAet 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., 37, 2129–2200 (2016).
  • Wang TJ , EvansJC, BenjaminEJ, LevyD, LeRoyEC, VasanRS. Natural history of asymptomatic left ventricular systolic dysfunction in the community. Circulation, 108, 977–982 (2003).
  • Investigators S , YusufS, PittB, DavisCE, HoodWB Jr, CohnJN. Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. N. Engl. J. Med., 327, 685–691 (1992).
  • Butler J , FonarowGC, ZileMRet al. Developing therapies for heart failure with preserved ejection fraction: current state and future directions. JACC Heart Fail., 2, 97–112 (2014).
  • Mosterd A , HoesAW. Clinical epidemiology of heart failure. Heart, 93, 1137–1146 (2007).
  • Redfield MM , JacobsenSJ, BurnettJC Jr, MahoneyDW, BaileyKR, RodehefferRJ. Burden of systolic and diastolic ventricular dysfunction in the community: appreciating the scope of the heart failure epidemic. JAMA, 289, 194–202 (2003).
  • Bleumink GS , KnetschAM, SturkenboomMCJMet al. Quantifying the heart failure epidemic: prevalence, incidence rate, lifetime risk and prognosis of heart failure the Rotterdam study. Eur. Heart J., 25, 1614–1619 (2004).
  • Ceia F , FonsecaC, MotaTet al. Prevalence of chronic heart failure in Southwestern Europe: the EPICA study. Eur. J.Heart Fail., 4, 531–539 (2002).
  • Maggioni A , DahlströmU, FilippatosGet al. EURObservational Research Programme: regional differences and 1-year follow-up results of the Heart Failure Pilot Survey (ESC-HF Pilot). Eur. J. Heart Fail., 15, 808–817 (2013).
  • Pocock SJ , AritiCA, McMurrayJJVet al. Predicting survival in heart failure: a risk score based on 39 372 patients from 30 studies. Eur. Heart J., 34, 1404–1413 (2013).
  • SOLVD Investigators , YusufS, PittB, DavisCE, HoodWB, CohnN. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N. Engl. J. Med., 325, 293–302 (1991).
  • Packer MP , Poole-WilsonA, ArmstrongPWet 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, 100, 2312–2318 (1999).
  • Pfeffer MA , SwedbergK, GrangerCBet al. Effects of candesartan on mortality and morbidity in patients with chronic heart failure: the CHARM-Overall programme. Lancet, 362, 759–766 (2003).
  • Cohn JN , TognoniGI Valsartan Heart Failure Trial. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N. Engl. J. Med., 345, 1667–1675 (2001).
  • Pfeffer MA , McMurrayJJV, VelazquezEJet al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N. Engl. J. Med., 349, 1893–1906 (2003).
  • Pitt B , ZannadF, RemmeWJet al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N. Engl. J. Med., 341, 709–717 (1999).
  • Zannad F , McMurrayJJV, KrumHet al. Eplerenone in patients with systolic heart failure and mild symptoms. N. Engl. J. Med., 364, 11–21 (2011).
  • Hjalmarson A , GoldsteinS, FagerbergBet al. Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group. JAMA, 283, 1295–1302 (2000).
  • Packer M , CoatsAJ, FowlerMBet al. Effect of carvedilol on survival in severe chronic heart failure. N. Engl. J. Med., 344, 1651–1658 (2001).
  • Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet, 353, 2001–2007 (1999).
  • Swedberg K , KomajdaM, BöhmMet al. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet, 376, 875–885 (2010).
  • Bohm M , BorerJ, FordIet al. Heart rate at baseline influences the effect of ivabradine on cardiovascular outcomes in chronic heart failure: analysis from the SHIFT study. Clin. Res. Cardiol., 102, 11–22 (2013).
  • Antiarrhythmics versus implantable defibrillators investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N. Engl. J. Med., 337, 1576–1583 (1997).
  • Connolly SJ , HallstromAP, CappatoRet al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg. Canadian Implantable Defibrillator Study. Eur. Heart J., 21, 2071–2078 (2000).
  • Cleland JG , AbrahamWT, LindeCet al. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur. Heart J., 34, 3547–3556 (2013).
  • Jankowska EA , TkaczyszynM, SuchockiTet al. Effects of intravenous iron therapy in iron-deficient patients with systolic heart failure: a meta-analysis of randomized controlled trials. Eur. J. Heart Fail., 18, 786–795 (2016).
  • McMurray JJV , SolomonSD, InzucchiSEet al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N. Engl. J. Med., 381, 1995–2008 (2019).
  • Yancy CW , JessupM, BozkurtBet 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: 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., 68, 1476–1488 (2016).
  • McMurray JJ , PackerM, DesaiASet al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N. Engl. J. Med., 371, 993–1004 (2014).
  • Akintoye E , BriasoulisA, EgbeAet al. National trends in admission and in-hospital mortality of patients with heart failure in the United States (2001–2014). J.Am. Heart Assoc., 6(12), e006955 (2017).
  • Maisel AS , DuranJM, WetterstenN. Natriuretic peptides in heart failure: atrial and b-type natriuretic peptides. Heart Fail. Clin., 14, 13–25 (2018).
  • Trippodo NC , FoxM, MonticelloTM, PanchalBC, AsaadMM. Vasopeptidase inhibition with omapatrilat improves cardiac geometry and survival in cardiomyopathic hamsters more than does ACE inhibition with captopril. J. Cardiovasc. Pharmacol., 34, 782–790 (1999).
  • Gu J , NoeA, ChandraPet al. Pharmacokinetics and pharmacodynamics of LCZ696, a novel dual-acting angiotensin receptor-neprilysin inhibitor (ARNi). J. Clin. Pharmacol., 50, 401–414 (2010).
  • Hegde LG , YuC, RennerTet 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., 57, 495–504 (2011).
  • Monge M , LorthioirA, BobrieG, AziziM. New drug therapies interfering with the renin-angiotensin-aldosterone system for resistant hypertension. J. Renin Angiotensin Aldosterone Syst., 14, 285–289 (2013).
  • Ragab MAA , GalalSM, KoranyMA, AhmedAR. First derivative emission spectrofluorimetric method for the determination of LCZ696, a newly approved FDA supramolecular complex of valsartan and sacubitril in tablets. Luminescence, 32, 1417–1425 (2017).
  • Federico C . Natriuretic peptide system and cardiovascular disease. Heart Views, 11, 10–15 (2010).
  • Menendez JT . The mechanism of action of LCZ696. Card. Fail. Rev., 2, 40–46 (2016).
  • Ishii M , KaikitaK, SatoKet al. Cardioprotective effects of LCZ696 (sacubitril/valsartan) after experimental acute myocardial infarction. JACC Basic Transl. Sci., 2, 655–668 (2017).
  • Kenny AJ , BourneA, IngramJ. Hydrolysis of human and pig brain natriuretic peptides, urodilatin, C-type natriuretic peptide and some C-receptor ligands by endopeptidase-24.11. Biochem. J., 291(Pt 1), 83–88 (1993).
  • Rademaker MT , CharlesCJ, EspinerEA, NichollsMG, RichardsAM, KosoglouT. Neutral endopeptidase inhibition: augmented atrial and brain natriuretic peptide, haemodynamic and natriuretic responses in ovine heart failure. Clin. Sci. (Lond.), 91, 283–291 (1996).
  • Fitzpatrick MA , RademaerMT, CharlesCJet al. Acute hemodynamic, hormonal, and renal effects of neutral endopeptidase inhibition in ovine heart failure. J. Cardiovasc. Pharmacol., 19, 635–640 (1992).
  • Seymour A , AsaadMM, LanoceVM, FennellSA, CheungHS, RogersWL. Inhibition of neutral endopeptidase 3.4.24.11 in conscious dogs with pacing induced heart failure. Cardiovasc. Res., 27, 1015–1023 (1993).
  • Han Y , AyalasomayajulaS, PanWet al. Pharmacokinetics, safety and tolerability of sacubitril/valsartan (LCZ696) after single-dose administration in healthy Chinese subjects. Eur. J. Drug Metab. Pharmacokinet., 42, 109–116 (2017).
  • Shi J , WangX, NguyenJ, WuAH, BleskeBE, ZhuH-J. Sacubitril is selectively activated by carboxylesterase 1 (CES1) in the liver and the activation is affected by CES1 genetic variation. Drug Metab. Dispos., 44, 554–559 (2016).
  • Flarakos J , DuY, BedmanTet al. Disposition and metabolism of [(14)C] sacubitril/valsartan (formerly LCZ696) an angiotensin receptor neprilysin inhibitor, in healthy subjects. Xenobiotica, 46, 986–1000 (2016).
  • Waldmeier F , FleschG, MüllerPet al. Pharmacokinetics, disposition and biotransformation of [14C]-radiolabelled valsartan in healthy male volunteers after a single oral dose. Xenobiotica, 27, 59–71 (1997).
  • Solomon SD , ClaggettB, DesaiASet al. 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. Circ. Heart Fail., 9, e002744 (2016).
  • Breathett K , AllenLA, UdelsonJ, DavisG, BristowM. Changes in left ventricular ejection fraction predict survival and hospitalization in heart failure with reduced ejection fraction. Circ. Heart Fail., 9(10), e002962 (2016).
  • Tsutsui H , MomomuraS, SaitoYet al. 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. J. Cardiol., 70, 225–231 (2017).
  • Jhund PS , ClaggettB, PackerMet al. Independence of the blood pressure lowering effect and efficacy of the angiotensin receptor neprilysin inhibitor, LCZ696, in patients with heart failure with preserved ejection fraction: an analysis of the PARAMOUNT trial. Eur. J. Heart Fail., 16, 671–677 (2014).
  • Solomon SD , ZileM, PieskeBet al. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a Phase II double-blind randomised controlled trial. Lancet, 380, 1387–1395 (2012).
  • Solomon SD , McMurrayJJV, AnandISet al. Angiotensin-neprilysin inhibition in heart failure with preserved ejection fraction. N. Engl. J. Med., 381, 1609–1620 (2019).
  • Januzzi JL Jr , PrescottMF, ButlerJet al. Association of change in N-terminal pro-B-type natriuretic peptide following initiation of sacubitril-valsartan treatment with cardiac structure and function in patients with heart failure with reduced ejection fraction. JAMA, 322, 1–11 (2019).
  • Chang HY , FengA-N, FongM-Cet al. Sacubitril/valsartan in heart failure with reduced ejection fraction patients: real world experience on advanced chronic kidney disease, hypotension, and dose escalation. J. Cardiol., 74, 372–380 (2019).
  • El-Battrawy I , PilsingerC, LiebeVet al. Impact of sacubitril/valsartan on the long-term incidence of ventricular arrhythmias in chronic heart failure patients. J. Clin. Med., 8, doi:10.3390/jcm8101582 (2019).
  • Lopez-Azor JC , vincntL, Valero-MasMJet al. Safety of sacubitril/valsartan initiated during hospitalization: data from a non-selected cohort. ESC Heart Fail., 6, 1161–1166 (2019).
  • Senni M , WachterR, WitteKKet al. Initiation of sacubitril/valsartan shortly after hospitalisation for acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure: a subgroup analysis of the TRANSITION study. Eur. J. Heart Fail., 22, 303-312 (2019).
  • Pellicori P , UrbinatiA, ShahPet al. What proportion of patients with chronic heart failure are eligible for sacubitril-valsartan? Eur. J. Heart Fail., 19, 768–778 (2017).
  • Vardeny O , ClaggettB, PackerMet 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., 18, 1228–1234 (2016).
  • Norberg H , BergdahlE, LindmarkK. Eligibility of sacubitril-valsartan in a real-world heart failure population: a community-based single-centre study. ESC Heart Fail., 5, 337–343 (2018).
  • Tsioufis C , GGeorgiopoulos, OikonomouDet al. Hypertension and heart failure with preserved ejection fraction: connecting the dots. Curr. Vasc. Pharmacol., 16, 15–22 (2017).
  • Solomon SD , ClaggettB, McMurrayJJ, HernandezAF, FonarowGC. Combined neprilysin and renin-angiotensin system inhibition in heart failure with reduced ejection fraction: a meta-analysis. Eur. J. Heart Fail., 18, 1238–1243 (2016).
  • Li Q , LiL, WangFet al. Effect and safety of LCZ696 in the treatment of hypertension: ameta-analysis of 9 RCT studies. Medicine (Baltimore), 98, e16093 (2019).
  • Pascual-Figal D , WachterR, SenniMet al. Rationale and design of TRANSITION: a randomized trial of pre-discharge vs post-discharge initiation of sacubitril/valsartan. ESC Heart Fail., 5, 327–336 (2018).
  • Senni M , McMurrayJJV, WachterRet al. Initiating sacubitril/valsartan (LCZ696) in heart failure: results of titration, a double-blind, randomized comparison of two uptitration regimens. Eur. J. Heart Fail., 18, 1193–1202 (2016).
  • Obtulowicz K . Bradykinin-mediated angioedema. Pol. Arch. Med. Wewn., 126, 76–85 (2016).
  • Velazquez EJ , MorrowDA, DeVorADet al. Angiotensin-neprilysin inhibition in acute decompensated heart failure. N. Engl. J. Med., 380, 539–548 (2019).
  • Bakris GL , WeirMR. Angiotensin-converting enzyme inhibitor-associated elevations in serum creatinine: is this a cause for concern?Arch. Intern. Med., 160, 685–693 (2000).
  • de Diego C , González-TorresL, NúñezJMet al. Effects of angiotensin-neprilysin inhibition compared to angiotensin inhibition on ventricular arrhythmias in reduced ejection fraction patients under continuous remote monitoring of implantable defibrillator devices. Heart Rhythm, 15, 395–402 (2018).
  • Martens P , NuyensD, Rivero-AyerzaMet al. Sacubitril/valsartan reduces ventricular arrhythmias in parallel with left ventricular reverse remodeling in heart failure with reduced ejection fraction. Clin. Res. Cardiol., 108, 1074–1082 (2019).
  • Frazier CG , AlexanderKP, NewbyLKet al. Associations of gender and etiology with outcomes in heart failure with systolic dysfunction: a pooled analysis of 5 randomized control trials. J. Am. Coll. Cardiol., 49, 1450–1458 (2007).
  • Ng AC , SindoneAP, WongHS, FreedmanSB. Differences in management and outcome of ischemic and non-ischemic cardiomyopathy. Int. J. Cardiol., 129, 198–204 (2008).
  • Balmforth C , SimpsonJ, ShenLet al. Outcomes and effect of treatment according to etiology in HFrEF: an analysis of PARADIGM-HF. JACC Heart Fail., 7, 457–465 (2019).
  • Desai AS , McMurrayJJV, PackerMet al. Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients. Eur. Heart J., 36, 1990–1997 (2015).
  • Hopper I , KotechaD, ChinKL, MentzRJ, von LuederTG. Comorbidities in heart failure: are there gender differences?Curr. Heart Fail. Rep., 13, 1–12 (2016).
  • Gan L , LangenickelT, PetruckJet al. Effects of age and sex on the pharmacokinetics of LCZ696, an angiotensin receptor neprilysin inhibitor. J. Clin. Pharmacol., 56, 78–86 (2016).
  • Jhund PS , FuM, BayramEet al. Efficacy and safety of LCZ696 (sacubitril-valsartan) according to age: insights from PARADIGM-HF. Eur. Heart J., 36, 2576–2584 (2015).
  • Joly JM , DesaiAS. Sacubitril/valsartan: from clinical trials to real-world experience. Curr. Treat. Options Cardiovasc. Med., 20, 45 (2018).
  • Simpson J , JhundPS, SilvaCardoso Jet al. Comparing LCZ696 with enalapril according to baseline risk using the MAGGIC and EMPHASIS-HF risk scores: an analysis of mortality and morbidity in PARADIGM-HF. J. Am. Coll. Cardiol., 66, 2059–2071 (2015).
  • Kristensen SL , PreissDS, JhundPSet al. Risk related to pre-diabetes mellitus and diabetes mellitus in heart failure with reduced ejection fraction: insights from prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure trial. Circ. Heart Fail., 9, doi:10.1161/CIRCHEARTFAILURE.115.002560 (2016).
  • Okumura N , JhundPS, GongJet al. Effects of sacubitril/valsartan in the PARADIGM-HF trial (prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure) according to Background therapy. Circ. Heart Fail., 9, doi:10.1161/CIRCHEARTFAILURE.116.003212 (2016).
  • Yancy CW , JessupM, BozkurtBet al. 2017 ACC/AHA/HFSA focused 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. Card. Fail., 23, 628–651 (2017).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.