Neurohormonal blockade: is there still room to go?

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1 Neurohormonal blockade: is there still room to go? M.Birhan YILMAZ, MD, FESC, FACC, FHFA Professor of Cardiology, Cumhuriyet University Sivas, TURKEY President of Heart FailureWG of Turkish Society of Cardiology Disclosures: Research fee from Novartis (Serelaxin, LCZ696), Cardiorentis(Ularitide), speaker honorariumfrom Orion

2 HF treatment goals focus on prognosis, morbidity and prevention Objectives of treatment for chronic HF Prognosis Morbidity Prevention Reduce mortality Relieve symptoms and signs Improve quality of life Eliminate edema and fluid retention Increase exercise capacity Reduce fatigue and breathlessness Reduce the need for hospitalization Provide end of life care Prevent the occurrence of myocardial damage Prevent the progression of myocardial damage Prevent the remodelling of the myocardium Prevent the reoccurrence of symptoms and fluid accumulation Prevent hospitalization McMurray et al. Eur Heart J 2012;33:

3 The pathophysiology of HFrEF Damage to cardiac myocytes and extracellular matrix leads to changes in the size, shape and function of the heart and cardiac wall stress 1,2 Systemic neurohormonal overactivation 2 Vasoconstriction, fibrosis, apoptosis, hypertrophy, cellular and molecular alterations, myotoxicity 2,3 Maladaptive remodeling and progressive worsening of LV function 2 Hemodynamic alterations, salt and water retention 2 1. McMurray. N EnglJ Med 2010;362:228 38; 2. Krum, Abraham. Lancet 2009;373:941 55; 3. Francis et al. Ann Intern Med 1984;101: HFrEF* - heart failure with reduced ejection fraction Morbidity and mortality: arrhythmias, pump failure 2 HF symptoms: dyspnea, edema, fatigue 2

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5 Heart failure therapy has evolved over time H-ISDN b (hydralazine and isosorbide dinitrate) MRAs a,d (e.g. spironolactone, eplerenone) Nitrates d (nitroglycerine) ACEIs a,d (e.g. captopril, enalapril) Natriuretic peptide d (nesiritide) VRA e (tolvaptan) Pre Digoxin b,d Inotropes d (dobutamine) Loop diuretics c (e.g. furosemide, bumetanide) Beta-blocker a,d (bisoprolol) ARBs b (valsartan) SNI b,f (ivabradine) Only the first approval time for each therapeutic class is shown. a ESC recommended treatment for potentially all patients with symptomatic (NYHA functional class II IV) systolic heart failure b ESC recommended treatment with less-certain benefits in patients with symptomatic (NYHA class II IV) systolic heart failure c ESC recommended treatment in patients with and without a preserved ejection fraction, chronic and acute heart failure d ESC recommended treatment in patients with patients with acute heart failure e Tolvaptan may be used to treat patients with resistant hyponatremia f European Medical Agency has approved ivabradine for use in patients with a heart rate 75 bpm. May also be considered in patients with a contraindication to β-blockers. ACEI: angiotensin-converting enzyme inhibitor; ARB: angiotensin-receptor blocker; MRA: mineralocorticoid receptor antagonist; SNI: sinus node If channel inhibitor; VRA: vasopressin receptor antagonist. McMurray et al. Eur Heart J 2012;33:

6 Systolic dysfunction leads to activation of three major neurohormonal systems Natriuretic peptide system 1 NPRs NPs Vasoconstriction Blood pressure Sympathetic tone Natriuresis/diuresis Vasopressin Aldosterone Fibrosis Hypertrophy HF SYMPTOMS & PROGRESSION Sympathetic nervous system 2,3 Epinephrine Norepinephrine α 1, β 1, β 2 receptors Vasoconstriction RAAS activity Vasopressin Heart rate Contractility Renin-angiotensinaldosterone-system 3,4 Ang II AT 1 R Ang = angiotensin; AT1R = angiotensin II type 1 receptor; HF = heart failure; NPs = natriuretic peptides; NPRs = natriuretic peptide receptors; RAAS = renin-angiotensin-aldosterone system Levin et al. N Engl J Med 1998;339:321 8; Nathisuwan & Talbert. Pharmacotherapy 2002;22:27 42; Kemp & Conte. Cardiovascular Pathology 2012; ; Schrier & Abraham. N Engl J Med 2009;341: Vasoconstriction Blood pressure Sympathetic tone Aldosterone Hypertrophy Fibrosis

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8 Overactivation of the RAAS and SNS underpins HF therapy 1 β-blockers SNS 3,4 Natriuretic peptide system 2 NPRs NPs Vasoconstriction Blood pressure Sympathetic tone Natriuresis/diuresis Vasopressin Aldosterone Fibrosis Hypertrophy HFrEF SYMPTOMS & PROGRESSION Epinephrine Norepinephrine RAAS inhibitors (ACEI, ARB, MRA) Ang II α 1, β 1, β 2 receptors Vasoconstriction RAAS activity Vasopressin Heart rate Contractility RAAS 4,5 AT 1 R Vasoconstriction Blood pressure Sympathetic tone Aldosterone Hypertrophy Fibrosis Sodium and water retention 1. McMurray et al. Eur Heart J 2012;33: ; 2. Levin et al. N Engl J Med 1998;339:321 8; 3. Nathisuwan & Talbert. Pharmacotherapy 2002;22:27 42; 4. Kemp & Conte. Cardiovascular Pathology 2012; ; 5. Schrier & Abraham. N Engl J Med 1999;341:

9 Clinical trials in HFrEF CHARM-Alt 2003 V-HeFT II 1991 Val-HeFT 2001 CHARM-Add 2003 HEAAL 2009 SOLVD-T 1991 CAPRICORN 2001 VALIANT 2003 HF-ACTION 2009 CONSENSUS 1987 SOLVD-P 1992 ELITE II 2000 EPHESUS 2003 MADIT-CRT 2009 V-HeFT I 1986 ELITE I 1997 COMET 2003 PARADIGM-HF ATLAS 1999 A-HeFT 2004 EMPHASIS 2011 R ALES 1999 SENIORS 2005 SHIFT 2010 ACEIs β-blockers CIBIS-II 1999 CARE-HF 2005 RAFT 2010 ARBs Others MERIT 1999 M RAs LCZ696

10 Chronic HFrEF survival rates have improved over time with the introduction of new therapies; however, significant mortality remains 5 ACEI * ARB * β-blocker * MRA * Reduction in relative risk of mortality vs placebo 16% 23% (4.5% ARR; mean follow up of 41.4 months) SOLVD 1 (3.0% ARR; median follow-up of 33.7 months) CHARM-Alternative 2 32% (5.5% ARR; mean follow up of 1.3 years) CIBIS-II 3 30% (11.0% ARR; mean follow up of 24 months) RALES 4 * On top of standard therapy at the time of study (except in CHARM-Alternative where background ACEI therapy was excluded). Patient populations varied between trials and as such relative risk reductions cannot be directly compared. SOLVD (Studies of Left Ventricular Dysfunction), CIBIS-II (Cardiac Insufficiency Bisoprolol Study II) and RALES (Randomized Aldactone Evaluation Study) enrolled chronic HF patients with LVEF 35%. CHARM-Alternative (Candesartan in Heart failure: Assessment of Reduction in Mortality and Morbidity) enrolled chronic HF patients with LVEF 40%. ARR: absolute risk reduction; HFrEF: heart failure with reduced ejection fraction; MRA: mineralocorticoid receptor antagonist; RRR: relative risk reduction 1. SOLVD Investigators. N Engl J Med 1991;325: ; 2. Granger et al. Lancet 2003;362: CIBIS-II Investigators. Lancet 1999;353:9 13; 4. Pitt et al. N Engl J Med 1999;341:709-17; 5. Roger et al. JAMA 2004;292:344 50

11 Natriuretic peptides have potential beneficial actions in HF Release of ANP and BNP from heart and CNP in vasculature 1 Sympathetic outflow 2 Vasopressin 2 Salt appetite and water intake 2 Na + /H 2 O loss 2 Aldosterone 2 Renin 2 CNP (endothelium) 3 ANP/BNP 2 Relaxation; arterial stiffness 4 Hypertrophy 2,5 7 Fibroblast proliferation 4,8,9 Vasodilation 2,3,4 Systemic vascular resistance 4 Pulmonary artery pressure 4 Pulmonary capillary wedge pressure 4 Right atrial pressure 4 ANP = atrial natriuretic peptide; BNP = B-type natriuretic peptide; CNP = C-type natriuretic peptide; HF = heart failure 1. Forssmann et al. Arch Histol Cytol 1989;52 Suppl: ; 2. Levin et al. N Engl J Med 1998;339;321 8; 3. Lumsden et al. Curr Pharm Des 2010;16:4080 8; 4. Langenickel & Dole. Drug Discovery Today: Ther Strateg 2012;9:e131 9; 5. Gardner et al. Hypertension 2007;49:419 26; 6. Tokudome et al. Circulation 2008;117; ; 7. Horio et al. Endocrinology 2003;144: ; 8. D'Souza et al. Pharmacol Ther 2004 ;101:113 29; 9. Cao & Gardner. Hypertension 1995;25:227 34;

12 How can I increase NP levels in body? 1. Simply by administering it (VMAC, ASCEND-HF, synthetic BNP analoque, only for BNP) 2. By decreasing their catabolism (commonpathway)

13 One Enzyme Neprilysin Degrades Many Endogenous Vasoactive Peptides Endogenous vasoactive peptides (natriuretic peptides, adrenomedullin, bradykinin, substance P, calcitonin gene-related peptide) Inactive metabolites

14 Neprilysin Inhibition Potentiates Actions of Endogenous Vasoactive Peptides That Counter Maladaptive Mechanisms in Heart Failure Endogenous vasoactive peptides (natriuretic peptides, adrenomedullin, bradykinin, substance P, calcitonin gene-related peptide) Neurohormonal activation Vascular tone Cardiac fibrosis, hypertrophy Sodium retention Neprilysin Neprilysin inhibition Inactive metabolites

15 Neprilysin (NEP) inhibition must be accompanied by simultaneous RAAS blockade Angiotensinogen Renin Ang I ACE Ang II NEP NEP Ang-(1 7) Inactive fragments AT 1 receptor Biological actions Signaling cascade Hypertrophy Fibrosis Vasoconstriction Hypertrophy Na+/H 2 O retention Aldosterone release Norepinephrine release Sympathetic tone ACE = angiotensin converting enzyme; AT 1 = angiotensin II type 1; Ang = angiotensin; NEP = neprilysin; RAAS = renin angiotensin aldosterone system Adapted from Von Lueder et al. Circ Heart Fail 2013;6:

16 Neprilysin is an enzyme with a high affinity to both ANP and CNP, and a low affinity for BNP Atrial natriuretic peptide (ANP) C-type natriuretic peptide (CNP) B-type natriuretic peptide (BNP) NH 2 NH 2 NH 2 COOH- COOH- COOH- Neprilysin has a high affinity for both ANP and CNP 1,3 Neprilysin inhibition predominantly enhances the effects of ANP and CNP, 1 leading to: Vasodilation Diuresis/natriuresis Proliferation Hypertrophy Aldosterone Sympathetic tone Cardiac preload Venous capacitance BNP is more resistant to hydrolysis by neprilysin than ANP and CNP 1,3 BNP decreases when neprilysin and RAAS are simultaneously inhibited 1,2 Decrease may reflect hemodynamic improvements in HF patients 4 Neprilysin does not hydrolyze NT-proBNP 1 NT-proBNP remains a useful biomarker of therapeutic effect and prognosis during neprilysin inhibition 1 ANP = atrial natriuretic peptide; BNP = B-type natriuretic peptide; CNP = C-type natriuretic peptide; HFrEF = heart failure with reduced ejection fraction; NT-proBNP = N-terminal pro B-type natriuretic peptide; RAAS = renin-angiotensin-aldosterone-system 1. Langenickel& Dole. Drug Discovery Today: Ther Strateg 2012;9:e Averkov et al. Presented at AHA Scientific Sessions, November 2010; 3. Von Lueder et al. Circ Heart Fail 2013;6: ; 4. Solomon et al. Lancet 2012;380:

17 LCZ696: Angiotensin Receptor Neprilysin Inhibition LCZ696 Angiotensin receptor blocker Inhibition of neprilysin

18 LCZ696 is a angiotensin receptor neprilysin inhibitor (ARNI) LCZ696 is a novel drug which delivers simultaneous neprilysin inhibition and AT 1 receptor blockade 1 3 LCZ696 is a salt complex that comprises the two active components in a 1:1 molar ratio: 2,3 sacubitril (AHU377) a pro-drug; further metabolized to the neprilysin inhibitor LBQ657, and 3D LCZ696 structure 2 valsartan an AT 1 receptor blocker ARNI = angiotensin receptor neprilysin inhibitor; AT 1 = angiotensin II type 1 1. Bloch, Basile. J Clin Hypertens 2010;12:809 12; 2. Gu et al. J Clin Pharmacol 2010;50:401 14; 3. Langenickel & Dole. Drug Discov Today: Ther Strateg 2012;9:e131 9

19 PARADIGM-HF: Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure PARADIGM-HF: Is the study to test the effect of LCZ696 on morbidity and mortality in patients with HFrEF Primarily evaluates whether simultaneous angiotensin receptor neprilysin inhibition with LCZ696 compared with enalapril, in addition to conventional HF treatment delays time to first occurrence of either CV death or HF hospitalization in patients with stable NYHA FC II IV HF and reduced ejection fraction (LVEF 40%*) Determine the place of the ARNI LCZ696 as an alternative to an ACEI (enalapril) in patients with chronic systolic HFrEF

20 PARADIGM-HF (2014) LCZ696 Enalapril LCZ mg BD n=4187 NYHA II IV, LVEF 40% Randomization Enalapril* 10 mg b.d n=4212 Primary endpoint: CV mortality or first hospitalization for HF Cumulative probability of death from CV causes or first hospitalization for HF Hazard Ratio = 0.80 (95% CI: ) p< Days since randomization Conclusions: LCZ696 was superior to enalapril in reducing the risks of death and of hospitalization for heart failure * In addition to recommended therapy LVEF: left ventricular ejection fraction; NYHA: New York Heart Association; BD: twice daily McMurray et al. N EnglMed 2014;371:

21 PARADIGM-HF: components of primary endpoint 1.0 Death from CV causes LCZ696 Enalapril Cumulative probability Hazard Ratio = 0.80 (95% CI: ) p<0.001 No. at risk LCZ696 Enalapril Days since randomization McMurray et al. N Engl Med 2014;371:

22 PARADIGM-HF: components of primary endpoint 1.0 First hospitalization for HF LCZ696 Enalapril Cumulative probability Hazard Ratio = 0.79 (95% CI: ) p<0.001 No. at risk LCZ696 Enalapril Days since randomization McMurray et al. N Engl Med 2014;371:

23 PARADIGM-HF: component of secondary endpoint 1.0 Death from any cause LCZ696 Enalapril Cumulative probability Hazard Ratio = 0.84 (95% CI: ) p<0.001 No. at risk LCZ696 Enalapril Days since randomization McMurray et al. N Engl Med 2014;371:

24 Drugs That Reduce Mortality in Heart Failure With Reduced Ejection Fraction 0% Angiotensin receptor blocker ACE inhibitor Beta blocker Mineralocorticoid receptor antagonist % Decrease in Mortality 10% 20% 30% 40% Drugs that inhibit the renin-angiotensin system have modest effects on survival Based on results of SOLVD-Treatment, CHARM-Alternative, COPERNICUS, MERIT-HF, CIBIS II, RALES and EMPHASIS-HF

25 How would LCZ696 have compared with placebo? (1/2) HR for LCZ696 vs imputed placebo HR for LCZ696 vs imputed placebo HR for LCZ696 vs enalapril (PARADIGM-HF 1 ) HR for enalapril vs * placebo (SOLVD- T 2 ) HR for LCZ696 vs candesartan (PARADIGM-HF)* HR for candesartan * vs placebo (CHARM- Alternative 3 ) LCZ696 LCZ696 PARADIGM-HF putative PARADIGM-HF putative Enalapril Placebo Candesartan Placebo SOLVD-T CHARM-Alternative *Based on the assumption that effect of LCZ696 vs. enalapril would be same as that of LCZ696 vs. candesartan CV, cardiovascular; HF, heart failure; HR, hazard ratio 1. McMurray et al. Eur Heart J 2015;36: The SOLVD Investigators. N Engl J Med 1991;325: Granger et al. Lancet 2003;362:

26 How would LCZ696 have compared with placebo? (2/2) CV death Hazard Ratio SOLVD-T CHARM-Alternative HR: 0.83 (0.73, 0.95), p=0.008 HR: 0.85 (0.71, 1.02), p=0.072 PARADIGM-HF putative placebo From SOLVD-T From CHARM-Alternative HR: 0.66 (0.56, 0.79), p< HR: 0.68 (0.55, 0.84), p= Favors active drug Favors placebo CV, cardiovascular; HF, heart failure; HR, hazard ratio; MRA, mineralocorticoid receptor antagonist; RRR, relative risk reduction McMurray et al. EurHeart J 2015;36:

27 PARADIGM-HF: prospectively defined safety events Event, n (%) LCZ696 (n=4187) Enalapril (n=4212) p-value Hypotension Symptomatic 588 (14.0) 388 (9.2) <0.001 Symptomatic with SBP <90 mmhg 112 (2.7) 59 (1.4) <0.001 Elevated serum creatinine 2.5 mg/dl 139 (3.3) 188 (4.5) mg/dl 63 (1.5) 83 (2.0) 0.10 Elevated serum potassium >5.5 mmol/l 674 (16.1) 727 (17.3) 0.15 >6.0 mmol/l 181 (4.3) 236 (5.6) Cough 474 (11.3) 601 (14.3) <0.001 Angioedema (adjudicated by a blinded expert committee) No treatment or use of antihistamines only 10 (0.2) 5 (0.1) 0.19 Catecholamines or glucocorticoids without hospitalization 6 (0.1) 4 (0.1) 0.52 Hospitalized without airway compromise 3 (0.1) 1 (<0.1) 0.31 Airway compromise McMurray et al. N Engl Med 2014;371:

28 NEUROHUMORAL ACTIVATION RENIN ANGIOTENSIN ALDOSTERONE ANGIOTENSIN II ALDOSTERONE SYMPATHETIC NERVOUS SYSTEM NOREPINEPHRINE VASOPRESSIN(ADH) ENDOTHELIN CYTOKINES UPSTREAM PATHWAYS (MİCRORNA)

29 Pharmacological therapies in HF An overview Drugs with proven efficacy in reducing mortality Inhibiting Ang II production or blocking AT1 receptors Competitive antagonists of betaadrenergic receptors Reduce release of renin Competitive antagonists of aldosterone receptor Therapies used in heart failure ARNİ ACEI, ARBs β-blockers MRAs Enalapril, captopril, valsartan, ca ndesartan, losartan Reduce preload and afterload Bisoprolol, carvedilol, metoprolol, nebivolol Spironolactone, eplerenone Reduce preload Drugs used to improve symptoms Inhibitors of Na+ reabsorption Competitive antagonists of vasopressin receptors No releasers Inhibitors of Na+/K+ ATPase Simulators of betaadrenergic receptors Inhibitors of camp degradation and increase adrenergic effect Thiazides Loop Diuretics Vaptans Organic nitrates Cardiac glycosides β-antagonists Phosphodiesterase inhibitors F u rosemide Hydrochlorothiazide Conivaptan Tolvaptan Nitrates N itroprusside Digoxin Dobutamine Milrinone Reduce preload Augment cardiac contractility ACEI: angiotensin-converting enzyme inhibitor; ARB: angiotensin-receptor blocker; AT: angiotensin; camp: cyclic adenosine monophosphate; β-b: β-blocker; MRA: mineralocorticoid receptor antagonist; NO: nitrous oxide. McMurray et al. Eur Heart J 2012;33:

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