Novel PCSK9 Outcomes. in Perspective: Lessons from FOURIER & ODYSSEY LDL-C. ASCVD Risk. Suboptimal Statin Therapy

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1 LDL-C Novel PCSK9 Outcomes Suboptimal Statin Therapy ASCVD Risk in Perspective: Lessons from FOURIER & ODYSSEY Jennifer G. Robinson, MD, MPH Professor, Departments of Epidemiology & Medicine Director, Prevention Intervention Center University of Iowa Iowa City, Iowa

2 Disclosures Jennifer G. Robinson, MD, MPH Research Grants to Institution: Acasti, Amarin, Amgen, AstraZeneca, Esai, Esperion, Merck, Pfizer, Regeneron, Sanofi, Takeda Consultant: Amgen, Merck, Novo Nordisk, Pfizer, Regeneron, Sanofi Vice Chair, 2013 ACC/AHA Cholesterol Guideline 2

3 Proportional Reduction in Event Rate (SE) LDL-C lowering drugs to date Major CVD Event (MACE) Reduction over Mean/median duration: Statins (5 years), Ezetimibe (7 years), PCSK9 mabs (11-34 months) OSLER I & II LDL-C mg/dl ODYSSEY LONGTERM/ASCVD* LDL-C mg/dl IMPROVE-IT ASCVD LDL-C mg/dl ( mmol/l) FOURIER mg/dl ODYSSEY OUTCOMES mg/dl Reduction in LDL-C (mmol/l) *Applied FOURIER inclusion criteria to LONG TERM. ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; LDL-C, low-density lipoprotein cholesterol mab, monoclonal antibodypcsk9, proprotein convertase subtilisin/kinexin type 9. CTT Collaboration. Lancet. 2005;366: ; Cannon CP et al. N Engl J Med. 2015;372: ; Robinson JG et al. N Engl J Med. 2015;372: ; Sabatine MS et al. N Engl J Med. 2015;372: ; The HPS2-THRIVE Collaborative Group. N Engl J Med. 2014;371: ; The ACCORD Study Group. N Engl J Med. 2010;362: ; AIM-HIGH. N Engl J Med. 2011;365: ; Sabatine M et al. N Engl J Med. doi /NEJMoa ; Robinson JG et al. Presented at ACC Poster number

4 FOURIER too short? Landmark analyses ASCVD Year 2 25% RRR Less than 35% RRR expected from CTT for 1.6 mmol/l LDL-C ASCVD=CVD death, myocardial infarction, stroke Sabatine M et al. N Engl J Med. 2017;376:

5 No Reason to Expect Greater RRR After 2 Years Based on 5 RCTs Mod vs High Intensity Statin Events (% p.a.) Year More statin Less statin 0-1 year 1-2 years 2-3 years 3-4 years 4-5 years 5+ years 1396 (7.4) 1641 (8.8) 645 (3.8) 741 (4.4) 499 (3.6) 603 (4.4) 470 (3.6) 522 (4.1) 414 (3.7) 476 (4.4) 413 (3.9) 433 (4.1) RR (CI) per 1 mmol/l reduction in LDL-C 0.72 ( ) 0.72 ( ) 0.66 ( ) 0.75 ( ) 0.69 ( ) 0.83 ( ) Cumulative RRR/1 mmol/l 28% 30% 29% 29% 27% All years 3837 (4.5) 4416 (5.3) 0.72 ( ) Years (3.7) 2775 (4.3) 0.72 ( ) 99% or 95% CI Test for heterogeneity between RR in first year and RR in years 1-5+: NS LDL-C lowering better LDL-C lowering worse CCT, Cholesterol Treatment Trialists; LDL-C, low-density lipoprotein cholesterol; MCVE, major cardiovascular events; RR, relative risk; RRR, relative risk reduction. Data from Accessed December 20, 2017.

6 Baseline LDL-C critical importance MACE: ODYSSEY vs FOURIER vs SPIRE II ODYSSEY OUTCOMES Mean baseline LDL-C 87 mg/dl (2.25 mmol/l) Mean LDL-C in treated group 49 months Median 2.8 years RRR 15% FOURIER Mean baseline LDL-C 92 mg/dl (2.4 mmol/l) Mean LDL-C in treated group 60 months Median 2.2 years RRR 15% SPIRE-2 Mean baseline LDL-C 134 mg/dl(3.5 mmol/l) Mean LDL-C in treated group 59 months Median 1-year RRR 21% LDL-C, low-density lipoprotein cholesterol; MACE, major adverse cardiac event; RRR, relative risk reduction. Sabatine M et al. N Engl J Med. 2017;376: ; Ridker PM et al. N Engl J Med. 2017;376: ; Schwartz G, et al Presented at ACC Scientific Sessions March 9, 2018 Orlando FL

7 Baseline LDL-C critically important ODYSSEY OUTCOMES 24% RRR vs. CTT Expected RRR 26% for 1.2* mmol/l LDL-C * Estimated midpoint of Week 4 LDL-C 54 mg/dl ( 1.4 mmol/l) & End of Study LDL-C 35 mg/dl ( 1 mmol/l) Schwartz G, et al Presented at ACC Scientific Sessions March 9, 2018 Orlando FL

8 Most benefit - baseline LDL-C >100 mg/dl ODYSSEY OUTCOMES ODYSSEY OUTCOMES LDL-C>100 mg/dl 24% RRR MACE Year 2+ Observed 29% RRR MACE vs. CTT expected for 26-34% RRR MACE 1.2 mmol/l LDL-C CTT Collaboration. Lancet. 2005;366: ; Data from Accessed December 20 ; Tice, JA et al. Insitute for Clinical and Economic Review. Alirocumab for High Cholesterol Preliminary New Evidence Update. March 10, 2018.

9 Why was relative risk reduction attenuated in FOURIER & ODYSSEY OUTCOMES LDL-C<100 mg/dl? 9

10 Baseline LDL-C drives total mortality reductions Meta-analyses statin, ezetimibe, PCSK9i RCTs Navarese EP & Robinson JG, et al. JAMA 2018; 319:

11 Baseline LDL-C drives CVD mortality reductions Meta-analyses statin, ezetimibe, PCSK9i RCTs Navarese EP & Robinson JG, et al. JAMA 2018; 319:

12 Largest Absolute CVD Risk Reduction Benefit in High-risk Patients with Higher LDL-C Levels Cardiovascular Event Rate (%) PCSK9 mab Greatest Benefit CHD + Diabetes CHD + MS or IFG 30 ODYSSEY CHD-No MS or IFG FOURIER Diabetes No CVD No CVD No Diabetes LDL (mg/dl) mmol/l Intent-to-treat LDL cholesterol level and risk for hard cardiovascular events CVD, cardiovascular disease; IFG, impaired fasting glucose; LDL-C, low-density lipoprotein cholesterol; mab, monoclonal antibody; MS, metabolic syndrome; PCSK9, proprotein convertase subtilisin/kinexin type 9. Risk curve concept: Robinson JG, Stone NJ. Am J Cardiol. 2006:98; ; FOURIER median of baseline LDL-C quartiles from Sabatine M, et al. Presented ACC Scientific Sessions; March 2017; Washington DC.; Schwartz G, et al Presented at ACC Scientific Sessions March 9, 2018 Orlando FL

13 WHY is LDL-C level important? Statins Statins+Evolocumab Puri, R., et al., Am J Cardiol, : p ; Nicholls, S.J., et al., JAMA, (22): p ; Robinson 2018 submitted. 13

14 14 Putting it all together Clinical guidance

15 NNT to Inform Nonstatin Decision Making Determine potential for NET BENEFIT from adding additional LDL-C lowering for additional CVD risk reduction NNT Number needed to treat to prevent one event 1 NNT = ARR Absolute risk reduction = Absolute CVD risk X Relative risk reduction from therapy ARR, absolute risk reduction; CVD, cardiovascular disease; LDL-C, low-density lipoprotein cholesterol; NNT, number needed to treat. Robinson JG et al. J Am Coll Cardiol. 2016;68:

16 Extremely High, Very High, and High-risk Patients ON STATINS: Who Are They? Extremely High Risk Very High Risk High Risk CVD++ CVD+ risk factors/fh+ risk factors CVD or FH, no risk factors 45% 10-year ASCVD Risk 30%-40% 10-year ASCVD Risk 20% 10-year ASCVD Risk CVD + FH CVD + polyvascular disease CVD + PVD CVD+ recurrent CVD events CVD+ LDL-C >100 mg/dl + CRP >3 mg/l CVD + diabetes (no polyvascular disease) CVD + chronic kidney disease (excluding hemodialysis) Recent acute coronary syndromes CVD + poorly controlled risk factors FH age years + poorly controlled CVD risk factors CVD+ high risk characteristics + CRP >3 mg/dl & LDL-C <100 mg/dl CVD with well-controlled risk factors FH age years, no or wellcontrolled risk factors ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; FH, familial hypercholesterolemia. Robinson JG, Watson K, et al. Rev Cardiovasc Med. 2018; Robinson JG et al. J Am Coll Cardiol. 2016;68:

17 ACS, acute coronary syndrome; CKD, chronic kidney disease; CVD, cardiovascular disease; DM, diabetes mellitus; FH, familial hypercholesterolemia; LDL-C, lowdensity lipoprotein cholesterol; PVD, polyvascular disease.; Robinson JG, Watson K. Rev Cardiovasc Med. 2018, In press. Patient Risk Groups: Risk Phenotypes Extremely High Risk Very High Risk High Risk >40% 10-year ASCVD risk CVD + FH CVD + PVD Polyvascular disease CVD + recurrent events CVD+comorbidities +CRP >3 mg/l 30-39% 10-year ASCVD risk CVD + DM (no PVD) CVD + CKD ACS CVD or FH + poorly controlled risk factors 20-29% 10- year ASCVD risk CVD + well controlled risk factors Primary prevention FH well controlled risk factors

18 NNT and Discounting: Some Groups PCSK9 mab Are Cost Effective in 2016 ICER analysis Cost Effectiveness (Based on 2016 ICER Analysis) NNT Very-high-risk individuals with LDL-C 190 mg/dl (4.9 mmol/l) or LDL-C 160 (4.1 mmol/l) mg/dl if 65% LDL-C reduction No discount / $150,000 QALY NNT Very-high-risk patients with LDL-C 100 mg/dl (2.6 mmol/l) High-risk patients with LDL-C 130 mg/dl (3.4 mmol/l) Depending on discount Discount 50% ( $7700/year) /$150,000 QALY Discount 60% ( $5400/year) /$100,000 QALY Discount 77% ( $3200/year) /$50,000 QALY Discount 85% ( $2200/year) to avoid exceeding growth targets US healthcare costs Cost per QALY gained over 5 years of treatment (assuming undiscounted acquisition cost of $14,000/year and 50% relative risk reduction with PCSK9 mab). All costs in US dollars. LDL-C, low-density lipoprotein cholesterol; mab, monoclonal antibodies; NNT, number needed to treat; PCSK9, proprotein convertase subtilisin/kinexin type 9; QALY, quality-adjusted life-year. Robinson JG et al. J Am Coll Cardiol. 2016;68: ; Tice JA et al. JAMA Intern Med. 2016;176:

19 CVD + FH CVD Plus++ = Extremely High Risk 45% 10-year ASCVD risk 5-year NNT to prevent 1 ASCVD event Initial LDL-C Ezetimibe LDL-C 20% PCSK9 mab LDL-C 50% PCSK9 mab 65% 190 mg/dl (4.9 mmol/l) mg/dl (4.1 mmol/l) mg/dl (3.4 mmol/l) mg/dl (2.6 mmol/l) mg/dl (1.8 mmol/l) 56 28* 22* Reasonable NNT thresholds: Physicians: NNT < 50; Patients: NNT <30 Patient case: Male, 52 y, post MI & LDL-C 105 mg/dl on atorvastatin 80 mg for 6 months Age & untreated LDL-C probably about 220 mg/dl ( 50%) suggests FH *2-year relative risk reduction for FOURIER CTT endpoint from Sabatine MS et al. N Engl J Med. 2015;372: ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; DM, diabetes mellitus; FH, familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; NNT, number needed to treat; mab, monoclonal antibody; PCSK9, proprotein convertase subtilisin/kinexin type 9. Robinson JG et al. J Am Coll Cardiol. 2016;68:

20 CVD Plus = Very High Risk 30% 10-year ASCVD risk 5-year NNT to prevent 1 ASCVD event Initial LDL-C Ezetimibe LDL-C 20% PCSK9 mab LDL-C 50% PCSK9 mab 65% 190 mg/dl (4.9 mmol/l) mg/dl (4.1 mmol/l) mg/dl (3.4 mmol/l) mg/dl (2.6 mmol/l) mg/dl (1.8 mmol/l) 88 43* 33* Reasonable NNT thresholds: Physicians: NNT < 50; Patients: NNT <30 Patient case: Man, 67 y, post MI, diabetes, & LDL-C 105 mg/dl on pravastatin 10 mg On maximally tolerated statin *2-year relative risk reduction for FOURIER CTT endpoint from Sabatine MS et al. N Engl J Med. 2015;372: ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; DM, diabetes mellitus; FH, familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; NNT, number needed to treat; mab, monoclonal antibody; PCSK9, proprotein convertase subtilisin/kinexin type 9. Robinson JG et al. J Am Coll Cardiol. 2016;68: ; Steel N. BMJ. 2000; 320:

21 High Risk 20% 10-year ASCVD risk 5-year NNTs Clinical ASCVD without high-risk characteristics (no diabetes/high-risk characteristics and primary LDL-C <190 mg/dl) Primary prevention FH (heterozygous; no clinical ASCVD; age >40 years) Initial LDL-C Ezetimibe 20% Percent LDL-C Reduction PCSK9 mab 50% PCSK9 mab 65% 190 mg/dl mg/dl mg/dl mg/dl mg/dl * 50* Reasonable NNT thresholds: Physicians: NNT < 50; Patients: NNT <30 Patient case: Man, 67 y, post MI, no diabetes, well-controlled risk factors & LDL-C 105 mg/dl on simvastatin 20 mg (maximally tolerated statin) *2-year relative risk reduction for FOURIER CTT endpoint from Sabatine MS et al. N Engl J Med. 2015;372: Robinson JG et al. J Am Coll Cardiol. 2016;68: ASCVD, atherosclerotic cardiovascular disease; FH, familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; NNT, number needed to treat.

22 High Priority Patient Groups Target Nonstatins Based on CVD Risk and LDL-C Extreme High Risk Very High Risk High Risk LDL-C >70 mg/dl CVD + FH CVD + PVD Polyvasular disease CVD + recurrent events CVD+comorbidities+ CRP >3 mg/l LDL-C >100 mg/dl CVD + DM (no PVD) CVD + CKD ACS CVD or FH + poorly controlled risk factors LDL-C >130 mg/dl CVD + well controlled risk factors Primary prevention FH well controlled risk factors ACS, acute coronary syndrome; CKD, chronic kidney disease; CVD, cardiovascular disease; DM, diabetes mellitus; FH, familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; PVD, polyvascular disease. Robinson JG, Watson K. Rev Cardiovasc Med.

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