Sacubitril/Valsartan in HFrEF for All Protagonist View George Honos MD FRCPC FCCS FACC

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1 Sacubitril/Valsartan in HFrEF for All Protagonist View George Honos MD FRCPC FCCS FACC Head of Cardiology Medical Manager / CV Program CHUM

2 Disclosure Statement Within the past two years: I have had an affiliation (financial or otherwise) with a commercial organization that may have a direct or indirect connection to the content of my presentation. Details below. Does your presentation describe the off-label use of a device, product, or drug that is approved for another purpose? No Type of Relationship A - Consulting Fees/Honoraria B - Officer, Director, Or In Any Other Fiduciary Role C Clinical Trials D - Ownership/Partnership/Principal E - Intellectual Property Rights F - Other Financial Benefit Modest (less than $10K) Sanofi, Roche, Lilly, Lantheus, Novo-Nordik, Novartis None None None None None Organization Name Significant (greater than $10K) Servier, Merck, BMS-Pfizer, Bayer, Boehringer-Ingelheim, Astra-Zeneca, Amgen,, Pfizer

3 >500,000 Canadians living with HF 50,000 new diagnoses each year 1.4 million hospital days per year $2.9 billion in estimated direct costs in Canada (2012) Ross et al. Can J Cardiol 2006;22(9):

4 Reduction in relative risk of mortality vs. placebo However, significant mortality ACEI* β-blocker* MRA* ARB* remains ~50% 16% of patients die 17% within 5 years (4.5% ARR; mean follow up of (3.0% ARR; median follow 41.4 months) up of 33.7 months) SOLVD 1,2 34% (5.5% ARR; mean follow up of diagnosis 6 8 of 1.3 years) CIBIS-II 3 30% (11.0% ARR; mean follow up of 24 months) RALES 4 CHARM- Alternative 5 Survival rates in chronic HF have improved with the introduction of new therapies 1 *On top of standard therapy at the time of the 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) enroled chronic HF patients with LVEF 40%. ACEI=angiotensin-converting-enzyme inhibitor; ARB=angiotensin receptor blocker; HF=heart failure; HFrEF=heart failure with reduced ejection fraction; LVEF=left ventricular ejection fraction; MRA=mineralocorticoid receptor antagonist 1. McMurray et al. Eur Heart J 2012;33: ; 2. SOLVD Investigators. N Engl J Med 1991;325: ; 3. Granger et al. Lancet 2003;362:772 6; 4. CIBIS-II Investigators. Lancet 1999;353:9 13; 5. Pitt et al. N Engl J Med 1999;341:709-17; 50; 6. Go et al. Circulation 2014;129:e28-e292; 7. Yancy et al. Circulation 2013;128:e ; 8. Levy et al. N Engl J Med 2002;347:

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6 Sacubitril/Valsartan Enhancing cgmp-mediated effects of natriuretic peptides Vasodilation Natriuretic and diuretic effects Proliferation Hypertrophy SNS outflow/sympathetic tone Aldosterone secretion Detrimental effects of vascular remodeling Suppressing RAAS-mediated effects Vasoconstriction Sodium and water retention Ventricular hypertrophy/remodeling Aldosterone secretion Cardiac fibrosis Sympathetic tone Systemic vascular resistance cgmp=cyclic guanosine monophosphate; RAAS=renin-angiotensin-aldosterone system; SNS=sympathetic nervous system Levin et al. N Engl J Med 1998;339:321 8 Nathisuwan & Talbert. Pharmacotherapy 2002;22:27 42 Schrier & Abraham. N Engl J Med 2009;341: Langenickel & Dole. Drug Discov Today: Ther Strateg 2012;9:e131 9

7 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi

8 Number of patients PARADIGM-HF 1 : The largest mortality-morbidity trial in patients with HFrEF 10,000 9,000 N=8442 8,000 7,000 N=6505 6,000 5,000 4,000 3,000 2,000 N=2569 N=2548 N=3834 N=1798 N=2737 1,000 0 SOLVD-T CHARM-Added HEAAL RAFT SHIFT EMPHASIS-HF PARADIGM-HF Recruitment CHARM-Added=Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity-added trial; EMPHASIS-HF=Eplerenone in Mild Patients Hospitalization And Survival study in Heart Failure; HEAAL=Heart failure Endpoint evaluation of Angiotensin II Antagonist Losartan; HFrEF=heart failure with reduced ejection fraction; PARADIGM-HF=Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure; RAFT=Resynchronization/Defibrillation for Ambulatory Heart Failure Trial; SHIFT=Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial; SOLVD-T=Studies of Left Ventricular Dysfunction Treatment trial McMurray et al. Eur J Heart Fail 2014;16:817 25

9 Cumulative probability Results: Primary endpoint: Death from CV causes or first hospitalization for HF Enalapril Sac/Val 0.4 Hazard ratio = 0.80 (95% CI: ) p< NNT*=21 patients Days since randomization No at risk Sac/Val Enalapril *Number needed to treat (NNT) evaluated over the duration of the trial McMurray et al. N Engl J Med 2014;371:

10 Number of deaths HR=0.84 (95% CI: ) p= PARADIGM-HF Results 835 HR*=0.80 (95% CI: ) p< HR=0.80 (95% CI: ) p=0.008 All causes CV causes Sudden cardiac death Cause of death The majority (>80%) of deaths in PARADIGM-HF had a CV cause 1 The mortality benefit of sacubitril/valsartan is related to the observed reduction in sudden cardiac death and death due to worsening heart failure 1 This distribution of cause of death in PARADIGM-HF is comparable to recent HFrEF trials 2 *Results from death from CV causes as per those reported by McMurray et al. Note that the hazard ratio reported by Desai et al. was HR=0.80 (95%CI: ); p< Sac/Val (N=4,187) Enalapril (N=4,212) HR=0.79 (95% CI: ) p= Worsening heart failure ACEI=angiotensin-converting-enzyme inhibitor; ARNI=angiotensin receptor neprilysin inhibitor; CI=confidence interval; CV=cardiovascular; HFrEF=heart failure with reduced ejection fraction; HR=Hazard ratio; PARADIGM-HF=Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure 1.Desai et al. Eur Heart J 2015; epub ahead of print: DOI: /eurheartj/ehv186; 2.O Connor et al. Am J Cardiol 1998;82:881 7

11 % Decrease in CV Mortality Sacubitril/Valsartan Doubles the Effect on CV Death of Current Renin- Angiotensin-Aldosterone System Inhibitors 0% Angiotensin receptor blocker1 ACE inhibitor Angiotensin + neprilysin inhibition 10% 15% 17% 20% 30% 20% 40% Effect of ARB vs placebo derived from CHARM-Alternative trial Effect of ACE inhibitor vs placebo derived from SOLVD-Treatment trial Effect of Sacubitril/Valsartan vs ACE inhibitor derived from PARADIGM-HF trial 1. McMurray et al. Eur Heart J 2015;36(7):

12 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi 2. Less side effects vs ACEi, incl. less hyper K +

13 Prospectively defined safety events Event, n (%) Sac/Val (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 Fewer patients in the sacubitril/valsartan group than in the enalapril group stopped their study medication because of an AE (10.7 vs 12.3%, p=0.03) McMurray et al. N Engl J Med 2014;371:

14 Patients who discontinued study drug (%) Adverse events leading to permanent study drug discontinuation Fewer patients in the sacubitril/valsartan group than in the enalapril group discontinued study drug due to an adverse event (10.7 vs 12.3%; p=0.03) 15 p= Sac/Val (n=4,187) Enalapril (n=4,212) 5 0 Any adverse event p=0.38 p= p= Hypotension Renal impairment Hyperkalemia McMurray et al. N Engl J Med 2014;371:

15 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi 2. Less side effects vs ACEi, incl. less hyper K + 3. Improved QOL vs ACEi

16 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi 2. Less side effects vs ACEi, incl. less hyper K + 3. Improved QOL vs ACEi 4. Consistent benefit within all subgroups

17 Sacubitril/Valsartan Showed Consistent Benefit over Enalapril, Across all Pre-Specified Subgroups This was observed for the primary end-point (CV death or HF hospitalization) and for death from CV causes 1 1. McMurray et al. N Engl J Med 2014;371:

18 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi 2. Less side effects vs ACEi, incl. less hyper K + 3. Improved QOL vs ACEi 4. Consistent benefit within all subgroups 5. Low dose as effective as full dose

19 Risk of primary outcome Sacubitril/Valsartan Efficacy was Maintained With Reduced Dose Compared to Reduced Dose of Enalapril Primary Outcome: Events After Dose Reduction Sac/Val Enalapril HR=0.80 ( 95% CI ) Days from Randomization No. at risk 1, Sacubitril/Valsartan 1, Enalapril Dose Level Sacubitril/ Valsartan Enalapril Vardeny O, et al. J Card Fail. 2015; 21(8):S9 S10 Event (N) HR (95% CI) P / mg 10 mg ( ) < / 51.4 mg /102.8 mg 5-10 mg ( ) < 48.6 / 51.4 mg < 5 mg ( ) CI=confidence interval; HR= hazard ratio; CV=cardiovascular; HF=heart failure; PARADIGM- HF=Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure 1. Vardeny et al. Journal of Cardiac Failure. August 2015: Volume 21, Issue 8, Supplement, S9. Abstract 260.

20 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi 2. Less side effects vs ACEi, incl. less hyper K + 3. Improved QOL vs ACEi 4. Consistent benefit within all subgroups 5. Low dose as effective as full dose 6. +/- MRA; +/- ICD; +/- NT Pro BNP level

21 The Benefit of Sacubitril/Valsartan over Enalapril was Consistent in Subgroups of Patients Receiving Different Therapies Beta-blocker target dose* MRA use Sub-group analyses as per the baseline use of concomitant therapy Enalapril n/n (%) Sacubitril/ Valsartan n/n (%) HR for CV death* (95% CI) 50% 266/1848 (14.4) 249/1919 (13.0) 0.89 (0.75,1.05) <50% 338/2027 (16.7) 266/1948 (13.7) 0.81 (0.69,0.96) No 304/1812 (16.8) 243/1916 (12.7) 0.75 (0.63, 0.89) Yes 389/2400 (16.2) 315/2271 (13.9) 0.84 ( ) Use of ICD (including CRT-D) No 609/3592 (17.0) 491/3564 (13.8) 0.80 (0.71,0.90) Yes 84/620 (13.6) 67/623 (10.8) 0.76 (0.55,1.05) Interaction p-value CI, confidence interval; CRT-D, cardiac resynchronization therapy defibrillator; CV, cardiovascular; CV, cardiovascular; HR, hazard ratio; ICD, implantable cardioverter defibrillator MRA, mineralocorticoid receptor antagonist 1. Okumara N, et al. Consistent benefit of sacubitril/valsartan over enalapril, irrespective of background therapy in PARADIGM HF. ACC (abstract) ; April 2016

22 Effect of treatment according to NT probnp level All-cause death Line of identity 95% CI LCZ696/ enalapril hazard ratio Baseline NT probnp (pg/ml) Courtesy of Dr. John McMurray Presented at ESC Rome 2016

23 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi 2. Less side effects vs ACEi, incl. less hyper K + 3. Improved QOL vs ACEi 4. Consistent benefit within all subgroups 5. Low dose as effective as full dose 6. +/- MRA; +/- ICD, +/- NT Pro BNP level 7. +/- RF; +/- albuminuria

24 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi 2. Less side effects vs ACEi, incl. less hyper K+ 3. Improved QOL vs ACEi 4. Consistent benefit within all subgroups 5. Low dose as effective as full dose 6. +/- MRA; +/- ICD, +/- NT Pro BNP level 7. +/- RF; +/- albuminuria 8. +/- EF; +/- stable HF; +/- HF risk score

25 Treatment effect of sacubitril/valsartan: CV death/hf hospitalization, CV death, all-cause mortality (A) Cardiovascular Death or HF Hospialization (B) Cardiovascular Death (C) All-Cause Mortality Favors sacubitril/valsartan Favors enalapril Favors sacubitril/valsartan Favors enalapril Favors sacubitril/valsartan Favors enalapril Overall Overall Overall Interaction p = 0.16 Interaction p = 0.66 Interaction p = 0.89 <3 Months ARR 3.2% <3 Months ARR 2.2% <3 Months ARR 2.4% 3 6 Months 3 6 Months 3 6 Months 6 12 Months 6 12 Months 6 12 Months >12 Months >12 Months >12 Months No Prior HF Hospitalization ARR 3.1% No Prior HF Hospitalization ARR 2.0% No Prior HF Hospitalization ARR 1.8%.5 Hazard Ratio Hazard Ratio Hazard Ratio Treatment effect of sacubitril/valsartan based on the presence of and time from a heart failure hospitalization prior to screening on the outcomes of (A) cardiovascular death or heart failure hospitalization (B) cardiovascular death, and (C) all-cause mortality CV, cardiovascular; HF, heart failure; SCD, sudden cardiac deaths Solomon et al. JACC 2016;13:1349

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28 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi 2. Less side effects vs ACEi, incl. less hyper K+ 3. Improved QOL vs ACEi 4. Consistent benefit within all subgroups 5. Low dose as effective as full dose 6. +/- MRA; +/- ICD, +/- NT Pro BNP level 7. +/- RF; +/- albuminuria 8. +/- EF; +/- stable HF; +/- HF risk score 9. Rapid impact 1 st 30 days

29 Kaplan-Meier estimate of cumulative rate The reduction in heart failure hospitalization with Sac/Val was evident within the first 30 days after randomization Enalapril (N=4,212) Sac/Val (N=4,187) HR 0.60 (95% CI: ) p= Days after randomization Shown is the Kaplan-Meier estimate of the cumulative probability of a first hospitalization for heart failure during the first 30 days after randomization. The analysis at 30 days was prespecified and also represented the earliest time point at which the difference between the Sac/Val and enalapril groups was statistically significant. Packer et al. Circulation. 2015;131:54 61.

30 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi 2. Less side effects vs ACEi, incl. less hyper K+ 3. Improved QOL vs ACEi 4. Consistent benefit within all subgroups 5. Low dose as effective as full dose 6. +/- MRA; +/- ICD 7. +/- RF; +/- albuminuria 8. +/- EF; +/- stable HF; +/- HF risk score 9. Rapid impact 1 st 30 days 10. Less re-hospitalization with HF

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32 Salcubitril/Valsartan in HFrEF for All Top 10 reasons why : 1. Greater efficacy vs ACEi 2. Less side effects vs ACEi, incl. less hyper K+ 3. Improved QOL vs ACEi 4. Consistent benefit within all subgroups 5. Low dose as effective as full dose 6. +/- MRA; +/- ICD, +/- NT Pro BNP level 7. +/- RF; +/- albuminuria 8. +/- EF; +/- stable HF; +/- HF risk score 9. Rapid impact 1 st 30 days 10. Less re-hospitalization with HF

33 Sacubitril/Valsartan Health Canada approved indication: Oct 2015 Treatment of heart failure with reduced ejection fraction (HFrEF) in patients with NYHA Class II or III symptoms, to reduce the incidence of cardiovascular death and heart failure hospitalisation 1 1 J.G. Howlett, The Canadian Cardiovascular Society HF companion; CJC 2015: 1-15

34 CCS HF Algorithm: Therapeutic Approach To Patients With CHF And Reduced Ejection Fraction Diuretics to relieve congestion Titrated to minimum effective dose to maintain euvolemia NYHA I Continue triple therapy NYHA I or LVEF <35% Continue present management Reassess every 1-3 years or with clinical status change Patient with LVEF <40% Triple Therapy ACEi (or ARB if ACEi intolerant), BB, MRA Titrate to target doses or maximum tolerated evidence-based dose Reassess Symptoms NYHA II-IV SR, HR 70 bpm ADD Ivabradine and SWITCH ACEi or ARB to LCZ696 for eligible patients Reassess Symptoms and LVEF NYHA I-III and LVEF 35% refer to ICD/CRT algorithm Consider LVEF reassessment every 1-5 years NYHA II-IV SR with HR < 70 bpm or AF or pacemaker SWITCH ACEi or ARB to LCZ696 for eligible patients NYHA IV Consider: Hydralazine/nitrates Referral for advanced HF therapy (mechanical circulatory support/transplant) Advance HF referral Reassess as needed according to clinical status Non-pharmacologic therapies (teaching self care, exercise) Advance Care Plan and Documentation of Goals of Care

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