Novel PCSK9 Outcomes. in Perspective: Lessons from FOURIER & ODYSSEY LDL-C. ASCVD Risk. Suboptimal Statin Therapy
|
|
- Daniella Fox
- 5 years ago
- Views:
Transcription
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.
What Role do the New PCSK9 Inhibitors Have in Lipid Lowering Treatment?
What Role do the New PCSK9 Inhibitors Have in Lipid Lowering Treatment? Jennifer G. Robinson, MD, MPH Professor, Departments of Epidemiology & Medicine Director, Prevention Intervention Center University
More informationMaking War on Cholesterol with New Weapons: How Low Can We/Should We Go? Shaun Goodman
Making War on Cholesterol with New Weapons: How Low Can We/Should We Go? Shaun Goodman Disclosures Research grant support, speaker/consulting honoraria: Sanofi and Regeneron Including ODYSSEY Outcomes
More informationCVD risk assessment using risk scores in primary and secondary prevention
CVD risk assessment using risk scores in primary and secondary prevention Raul D. Santos MD, PhD Heart Institute-InCor University of Sao Paulo Brazil Disclosure Honoraria for consulting and speaker activities
More informationLDL-C treatment goals were introduced in the first National
Point/Counterpoint Counterpoint: Low-Density Lipoprotein Cholesterol Targets Are Not Needed in Lipid Treatment Guidelines Jennifer G. Robinson, Kausik Ray Abstract On the basis of accumulating evidence,
More informationWhat have We Learned in Dyslipidemia Management Since the Publication of the 2013 ACC/AHA Guideline?
What have We Learned in Dyslipidemia Management Since the Publication of the 2013 ACC/AHA Guideline? Salim S. Virani, MD, PhD, FACC, FAHA Associate Professor, Section of Cardiovascular Research Baylor
More informationDoes IMPROVE-IT & FOURIER Confirm or Refute the LDL Hypothesis?
Does IMPROVE-IT & FOURIER Confirm or Refute the LDL Hypothesis? Controversies and Advances in the Treatment of Cardiovascular Disease The Seventeenth in the Series Beverly Hills, November 16, 2017 Sanjay
More informationContemporary management of Dyslipidemia
Contemporary management of Dyslipidemia Todd Anderson Feb 2018 Disclosure Statement Within the past two years: I have not had an affiliation (financial or otherwise) with a commercial organization that
More informationNew ACC/AHA Guidelines on Lipids: Are PCSK9 Inhibitors Poised for a Breakthrough?
New ACC/AHA Guidelines on Lipids: Are PCSK9 Inhibitors Poised for a Breakthrough? Sidney C. Smith, Jr. MD, FACC, FAHA Professor of Medicine/Cardiology University of North Carolina at Chapel Hill Immediate
More informationLipids: new drugs, new trials, new guidelines
Lipids: new drugs, new trials, new guidelines Milan Gupta, MD, FRCPC, FCCS State of the Heart Co-Chair Associate Clinical Professor of Medicine, McMaster University Assistant Professor of Medicine, University
More informationIs Lower Better for LDL or is there a Sweet Spot
Is Lower Better for LDL or is there a Sweet Spot ALAN S BROWN MD, FACC FNLA FAHA FASPC DIRECTOR, DIVISION OF CARDIOLOGY ADVOCATE LUTHERAN GENERAL HOSPITAL, PARK RIDGE, ILLINOIS DIRECTOR OF CARDIOLOGY,
More informationEvolving Concepts on Lipid Management from Ezetimibe (IMPROVE IT) to PCSK9 Inhibitors
Evolving Concepts on Lipid Management from Ezetimibe (IMPROVE IT) to PCSK9 Inhibitors Sidney C. Smith, Jr. MD, FACC, FAHA, FESC Professor of Medicine/Cardiology University of North Carolina at Chapel Hill
More informationGet a Statin or Not? Learning objectives. Presentation overview 4/3/2018. Treatment Strategies in Dyslipidemia Management
Get a Statin or Not? Treatment Strategies in Dyslipidemia Management Michelle Chu, PharmD, BCACP, CDE Assistant Professor of Clinical Pharmacy, USC School of Pharmacy Sahar Dagher, PharmD Virtual Care
More informationNew Strategies for Lowering LDL - Are They Really Worth It?
New Strategies for Lowering LDL - Are They Really Worth It? Gregg C. Fonarow, MD, FACC, FAHA, FHFSA Eliot Corday Professor of CV Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Co-Director,
More information4 th and Goal To Go How Low Should We Go? :
4 th and Goal To Go How Low Should We Go? : Evaluating New Lipid Lowering Therapies Catherine Bourg Rebitch, PharmD, BCACP Clinical Associate Professor Disclosure The presenter has nothing to disclose
More informationDisclosures. Objectives 2/11/2017
Role of Non-Statin Therapy in CV Risk Reduction James A. Underberg, MD, MS, FACPM, FACP, FASH, FNLA,FASPC Clinical Assistant Professor of Medicine NYU School of Medicine NYU Langone Center for Cardiovascular
More informationConfusion about guidelines: How should we treat lipids?
Confusion about guidelines: How should we treat lipids? Anne Carol Goldberg, MD, FACP, FAHA, FNLA Professor of Medicine Washington University School of Medicine American College of Physicians Missouri
More informationFOURIER: Enough Evidence to Justify Widespread Use? Did It fulfill Its Expectations?
FOURIER: Enough Evidence to Justify Widespread Use? Did It fulfill Its Expectations? CVCT Washington, DC November 3, 2017 Marc S. Sabatine, MD, MPH Chairman, TIMI Study Group Lewis Dexter, MD, Distinguished
More informationPCSK9 Inhibitors: Promise or Pitfall?
PCSK9 Inhibitors: Promise or Pitfall? Tracy Harlan, PharmD PGY2 Ambulatory Care Resident University of Iowa Hospitals and Clinics tracy harlan@uiowa.edu Tracy Harlan does not have any actual or potential
More informationPCSK9 Agents Drug Class Prior Authorization Protocol
PCSK9 Agents Drug Class Prior Authorization Protocol Line of Business: Medicaid P & T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of medical
More informationAccumulating Clinical data on PCSK9 Inhibition: Key Lessons and Challenges
ESC 2015 London Accumulating Clinical data on PCSK9 Inhibition: Key Lessons and Challenges Paul M Ridker, MD, MPH Eugene Braunwald Professor of Medicine Harvard Medical School Director, Center for Cardiovascular
More informationNew Horizons in Dyslipidemia Management in Primary Care
New Horizons in Dyslipidemia Management in Primary Care Copyright 2017 by Sea Courses Inc. All rights reserved. No part of this document may be reproduced, copied, stored, or transmitted in any form or
More informationPCSK9 Inhibitors and Modulators
PCSK9 Inhibitors and Modulators Pam R. Taub MD, FACC Director of Step Family Cardiac Rehabilitation and Wellness Center Associate Professor of Medicine UC San Diego Health System Disclosures Speaker s
More informationACC/AHA GUIDELINES ON LIPIDS AND PCSK9 INHIBITORS
ACC/AHA GUIDELINES ON LIPIDS AND PCSK9 INHIBITORS Ziyad Ghazzal MD, FACC, FSCAI Professor of Medicine Deputy Vice President/Dean Associate Dean for Clinical Affairs American University of Beirut Adjunct
More informationLandmesser U et al. Eur Heart J 2017; https://doi.org/ /eurheartj/ehx549
2017 Update of ESC/EAS Task Force on Practical Clinical Guidance for PCSK9 inhibition in Patients with Atherosclerotic Cardiovascular Disease or in Familial Hypercholesterolaemia Cardiovascular Outcomes
More informationDrug Class Monograph
Drug Class Monograph Class: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Drugs: Praluent (alirocumab), Repatha (evolocumab) Line of Business: Medi-Cal Effective Date: February 17, 2016
More informationCan We Cure Atherosclerosis?
Can We Cure Atherosclerosis? Jennifer G Robinson MD MPH Professor, Departments of Epidemiology & Medicine Director, Prevention Intervention Center University of Iowa What if you had a guide To guarantee
More informationEducational Objectives. Disease Trajectories and CVD Risk Reduction. Hypercholesterolemia Support for LDL-C Causality
Educational Objectives At the conclusion of this activity, participants should be able to: Evaluate the extent of residual CVD risk to which ASCVD patients are exposed, and treat additional CVD risk elements
More informationPamela B. Morris, MD, FACC, FAHA, FASPC, FNLA
2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-statin Therapies for LDL-C Lowering in the Management of ASCVD Risk Pamela B. Morris, MD, FACC, FAHA, FASPC, FNLA
More informationUpdate on Dyslipidemia and Recent Data on Treating the Statin Intolerant Patient
Update on Dyslipidemia and Recent Data on Treating the Statin Intolerant Patient Steven E. Nissen MD Chairman, Department of Cardiovascular Medicine Cleveland Clinic Disclosure Consulting: Many pharmaceutical
More informationNo relevant financial relationships
MANAGEMENT OF LIPID DISORDERS Balancing Benefits and harms Disclosure Robert B. Baron, MD MS Professor and Associate Dean UCSF School of Medicine No relevant financial relationships baron@medicine.ucsf.edu
More informationLandmark Clinical Trials.
Landmark Clinical Trials 1 Learning Objectives Discuss clinical trials and their role in lipid and lipoprotein treatment in cardiovascular prevention. Review the clinical trials of lipid-altering drug
More informationCholesterol, guidelines, targets and new medications
Cholesterol, guidelines, targets and new medications Alexis Baass MD, MSc, FRCPC, DABCL, FNLA Medical Biochemist and Lipidologist MUHC Clinical Researcher and Lipidologist IRCM Disclaimers Grants/Research
More information2017 Update in Internal Medicine: Clinical Dyslipidemia Update
2017 Update in Internal Medicine: Clinical Dyslipidemia Update Erin E. Kershaw, M.D. Chief, Division of Endocrinology Associate Professor of Medicine Certified in Endocrinology, Diabetes, and Metabolism
More informationManaging Dyslipidemia in Disclosures. Learning Objectives 03/05/2018. Speaker Disclosures
Managing Dyslipidemia in 2018 Glen J. Pearson, BSc, BScPhm, PharmD, FCSHP, FCCS Professor of Medicine (Cardiology) Co-Director, Cardiac Transplant Clinic; Associate Chair, Health Research Ethics Boards;
More information2/26/19. Secondary Cardiovascular Risk Reduction: Incorporating Evolving Data to Individualize Care. Disclosures. Faculty
Secondary Cardiovascular Risk Reduction: Incorporating Evolving Data to Individualize Care Faculty v Karol E. Watson, MD, PhD Professor of Medicine/Cardiology Co-director, UCLA Program in Preventive Cardiology
More informationSupplementary Online Content
Supplementary Online Content Navarese EP, Robinson JG, Kowalewski M, et al. Association between baseline LDL-C level and total and cardiovascular mortality after LDL-C lowering: a systematic review and
More informationPCSK9 Inhibitors Are They Worth The Money? Michael J. Blaha MD MPH
PCSK9 Inhibitors Are They Worth The Money? Michael J. Blaha MD MPH Presented by: Michael J. Blaha November 16, 2017 1 Financial Disclosures Grants: Amgen Foundation, Aetna Foundation Advisory Boards: Amgen,
More informationModern Lipid Management:
Modern Lipid Management: New Drugs, New Targets, New Hope Kirk U. Knowlton, M.D Director of Cardiovascular Research Co Chief of Cardiology Why lower LDL C in those without evidence of CAD (primary prevention)
More informationPCSK9 Inhibitors for Treatment of High Cholesterol. Public Meeting October 27, 2015
PCSK9 Inhibitors for Treatment of High Cholesterol Public Meeting October 27, 2015 Agenda Meeting Convened and Opening Remarks 10:00 AM- 10:15 AM Steven Pearson, MD, MSc, President, Institute for Clinical
More informationAlirocumab Treatment Effect Did Not Differ Between Patients With and Without Low HDL-C or High Triglyceride Levels in Phase 3 trials
Alirocumab Treatment Effect Did Not Differ Between Patients With and Without Low HDL-C or High Triglyceride Levels in Phase 3 trials G. Kees Hovingh, 1 Richard Ceska, 2 Michael Louie, 3 Pascal Minini,
More informationNEWS BRIEFING Diabetes and Cardiovascular Disease. Moderated by: Robert Eckel, MD University of Colorado
NEWS BRIEFING Diabetes and Cardiovascular Disease Moderated by: Robert Eckel, MD University of Colorado 1 EMBARGO POLICY All recordings are for personal use only and not for rebroadcast online or in any
More informationUpdate on Lipid Guidelines and Intense Treatment of LDL-C with PCSK9 Inhibitors Carl J. Lavie, MD,FACC,FACP,FCCP
Update on Lipid Guidelines and Intense Treatment of LDL-C with PCSK9 Inhibitors Carl J. Lavie, MD,FACC,FACP,FCCP Professor of Medicine Medical-Director, Preventive Cardiology John Ochsner Heart and Vascular
More informationATP IV: Predicting Guideline Updates
Disclosures ATP IV: Predicting Guideline Updates Daniel M. Riche, Pharm.D., BCPS, CDE Speaker s Bureau Merck Janssen Boehringer-Ingelheim Learning Objectives Describe at least two evidence-based recommendations
More informationCLINICAL OUTCOME Vs SURROGATE MARKER
CLINICAL OUTCOME Vs SURROGATE MARKER Statin Real Experience Dr. Mostafa Sherif Senior Medical Manager Pfizer Egypt & Sudan Objective Difference between Clinical outcome and surrogate marker Proper Clinical
More informationManagement of LDL as a Risk Factor. Raul D. Santos MD, PhD Heart Institute-InCor University of Sao Paulo Brazil
Management of LDL as a Risk Factor Raul D. Santos MD, PhD Heart Institute-InCor University of Sao Paulo Brazil Disclosure Consulting for: Merck, Astra Zeneca, ISIS- Genzyme, Novo-Nordisk, BMS, Pfizer,
More informationJUPITER NEJM Poll. Panel Discussion: Literature that Should Have an Impact on our Practice: The JUPITER Study
Panel Discussion: Literature that Should Have an Impact on our Practice: The Study Kaiser COAST 11 th Annual Conference Maui, August 2009 Robert Blumberg, MD, FACC Ralph Brindis, MD, MPH, FACC Primary
More informationSupplementary Online Content
Supplementary Online Content Cannon CP, Khan I, Klimchak AC, Reynolds MR, Sanchez RJ, Sasiela WJ. Simulation of lipid-lowering therapy intensification in a population with atherosclerotic cardiovascular
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2062-8 Program Prior Authorization/Medical Necessity Medication Praluent (alirocumab) P&T Approval Date 5/2015, 8/2015, 9/2015,
More informationEffective Treatment Options With Add-on or Combination Therapy. Christie Ballantyne (USA)
Effective Treatment Options With Add-on or Combination Therapy Christie Ballantyne (USA) Effective treatment options with add-on or combination therapy Christie M. Ballantyne, MD Center for Cardiovascular
More informationWhat s our starting point? New Lipid-Lowering Drugs: PCSK9 Inhibitors. Why You Should Care. Outline ATPIII Guidelines 1
New Lipid-Lowering Drugs: Inhibitors Blockbusters or Bust? Jody Mallicoat, BS, PharmD PGY1 Pharmacy Resident OSF Saint Francis Medical Center, Peoria, IL What s our starting point? Had you heard of inhibitors
More informationCase Presentation. Rafael Bitzur The Bert W Strassburger Lipid Center Sheba Medical Center Tel Hashomer
Case Presentation Rafael Bitzur The Bert W Strassburger Lipid Center Sheba Medical Center Tel Hashomer Case Presentation 50 YO man NSTEMI treated with PCI 1 month ago Medical History: Obesity: BMI 32,
More informationClass Update PCSK9 Inhibitors
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More information2016 ESC/EAS Guideline in Dyslipidemias: Impact on Treatment& Clinical Practice
2016 ESC/EAS Guideline in Dyslipidemias: Impact on Treatment& Clinical Practice Nattawut Wongpraparut, MD, FACP, FACC, FSCAI Associate Professor of Medicine, Division of Cardiology, Department of Medicine
More informationDisclosures No relationships (not even to an employer) No off-label uses. Cholesterol Lowering Guidelines: What now?
Disclosures No relationships (not even to an employer) No off-label uses Cholesterol Lowering Guidelines: What now?, FACP 1 2 65-year-old white woman Total cholesterol 175mg/dL HDL 54 mg/dl LDL 96 mg/dl
More informationPage 1 of 13. Produced: July 2018 NHS Midlands and Lancashire CSU Not for Commercial Use
New Medicine Recommendation Evolocumab (Repatha SureClick ) For prevention of cardiac events in patients with CHD and a history of ACS, in combination with a statin Recommendation: Black Evolocumab is
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2063-8 Program Prior Authorization/Medical Necessity Medication Repatha (evolocumab) P&T Approval Date 5/2015, 9/2015, 11/2015,
More informationAn update on lipidology and cardiovascular risk management. Lipids, Metabolism & Vascular Risk Section - Royal Society of Medicine
An update on lipidology and cardiovascular risk management Lipids, Metabolism & Vascular Risk Section - Royal Society of Medicine National and international lipid modification guidelines: A critical appraisal
More informationDisclosure. No relevant financial relationships. Placebo-Controlled Statin Trials
MANAGEMENT OF HYPERLIPIDEMIA AND CARDIOVASCULAR RISK IN WOMEN: Balancing Benefits and Harms Disclosure Robert B. Baron, MD MS Professor and Associate Dean UCSF School of Medicine No relevant financial
More informationStatins and PCSK9 inhibitors for stroke prevention
Statins and PCSK9 inhibitors for stroke prevention Haralampos Milionis Professor of Internal Medicine School of Medicine, University of Ioannina Ioannina, Greece Reduction in CV events (%) Every 1 mmol/l
More informationCost-effectiveness of evolocumab (Repatha ) for hypercholesterolemia
Cost-effectiveness of evolocumab (Repatha ) for hypercholesterolemia The NCPE has issued a recommendation regarding the cost-effectiveness of evolocumab (Repatha ). Following NCPE assessment of the applicant
More informationNephrologisches Zentrum Göttingen GbR Priv. Doz. Dr. med. V. Schettler
Therapeutic algorithm for Patients with severe Hypercholesterolemia or isolated Lipoprotein(a)-Hyperlipoproteinemia with progressive cardiovascular disease: PCSK9- Inhibitors, Lipoprotein Apheresis or
More informationLipid Management C. Samuel Ledford, MD Interventional Cardiology Chattanooga Heart Institute
Lipid Management 2018 C. Samuel Ledford, MD Interventional Cardiology Chattanooga Heart Institute Disclosures No Financial Disclosures Disclosures I am an Interventional Cardiologist I put STENTS in for
More informationPCSK9 Inhibitors: Changing the Landscape of Lipid-Lowering Therapy
PCSK9 Inhibitors: Changing the Landscape of Lipid-Lowering Therapy http://parriscardio.theangelheartcenter.com/wp-content/uploads/2013/03/heart-disease-prevention.jpg Jennifer Jiang, PharmD PGY1 Pharmacy
More informationLDL cholesterol and cardiovascular outcomes?
LDL cholesterol and cardiovascular outcomes? Prof Kausik Ray, BSc (hons), MBChB, FRCP, MD, MPhil (Cantab), FACC, FESC Professor of Cardiovascular Disease Prevention St Georges University of London Honorary
More informationReducing Cardiovascular Risk Through Non-Statins. Kim K. Birtcher, PharmD Joseph Saseen, PharmD
Reducing Cardiovascular Risk Through Non-Statins Kim K. Birtcher, PharmD Joseph Saseen, PharmD Target Audience: Pharmacists ACPE#: 0202-0000-18-049-L01-P Activity Type: Application-based This activity
More informationA New Age of Dyslipidemia Treatment: Role of Non- Statin Therapies
A New Age of Dyslipidemia Treatment: Role of Non- Statin Therapies BRODY MAACK, PHARMD, BCACP, CTTS Objectives 1. Review current guidelines regarding use of statin medications in the treatment and prevention
More informationAnne Carol Goldberg, MD, FACP, FAHA, FNLA Washington University, St. Louis, MO USA
Efficacy and Safety of Bempedoic Acid Added to Maximally Tolerated Statins in Patients with Hypercholesterolemia and High Cardiovascular Risk: The CLEAR Wisdom Trial Anne Carol Goldberg, MD, FACP, FAHA,
More informationLipid Therapy: Statins and Beyond. Ivan Anderson, MD RIHVH Cardiology
Lipid Therapy: Statins and Beyond Ivan Anderson, MD RIHVH Cardiology Outline The cholesterol hypothesis and lipid metabolism The Guidelines 4 Groups that Benefit from Lipid therapy Initiation and monitoring
More informationLipid Management: The Next Level How Will the New ACC/AHA Guidelines Change My Practice
Lipid Management: The Next Level How Will the New ACC/AHA Guidelines Change My Practice Vera Bittner, MD, MSPH Professor of Medicine Section Head, Preventive Cardiology Medical Director, Cardiac Rehabilitation
More informationDefining Severe Familial Hypercholesterolemia. Raul D. Santos MD, PhD Brazil
Defining Severe Familial Hypercholesterolemia Raul D. Santos MD, PhD Brazil 1 Disclosure Honoraria received for consulting, speaker and or researcher activities : Astra Zeneca, Akcea, Amgen, Biolab, Esperion,
More informationNew Approaches to Lower LDL-C
New Approaches to Lower LDL-C CSIM 27 October 2016 Jacques Genest MD Cardiovascular Health Across the Lifespan Program McGill University Health Center Disclosure J. Genest MD 2016 Advisory Board, Speaker
More informationManaging Lipids and Cardiovascular Risk: Using the Data to Optimize Care
Clinical Updates for Nurse Practitioners and Physician Assistants: 2018 Managing Lipids and Cardiovascular Risk: Using the Data to Optimize Care Faculty Robert L. Gillespie, MD, FACC, FASE, FASNC Immediate
More informationLDL and the Benefits of Statin Therapy
LDL and the Benefits of Statin Therapy Allan Sniderman McGill University ACC/AHA did not recommend a target-based approach. Right? P 2899 The Expert Panel was unable to find any RCTs that evaluated titration
More informationJohn J.P. Kastelein MD PhD Professor of Medicine Dept. of Vascular Medicine Academic Medial Center / University of Amsterdam
Latest Insights from the JUPITER Study John J.P. Kastelein MD PhD Professor of Medicine Dept. of Vascular Medicine Academic Medial Center / University of Amsterdam Inflammation, hscrp, and Vascular Prevention
More informationNew Guidelines in Dyslipidemia Management
The Fourth IAS-OSLA Course on Lipid Metabolism and Cardiovascular Risk Muscat, Oman, February 2018 New Guidelines in Dyslipidemia Management Dr. Khalid Al-Waili, MD, FRCPC, DABCL Senior Consultant Medical
More informationDyslipidemia and Combination Therapy: A Framework for Clinical Decision Making
Dyslipidemia and Combination Therapy: A Framework for Clinical Decision Making Shashank Sinha, MD Pamela B. Morris, MD, FACC 8 October 2016 Mexico City Introduction: Pamela B. Morris, MD, FACC COMING TO
More informationClass Update PCSK9 Inhibitors
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationStatins ARE Enough For The Prevention of CVD! Professor Kausik Ray Imperial College London, UK
1 Disclosures Advisory boards PCSK9- Sanofi/ Regeneron, Amgen, Pfizer, Roche, MSD NLI/ SC member for Odyssey- (Sanofi/ Regeneron), Roche Investigator initiated research grant support (Sanofi/Regeneron/
More informationMS Sabatine, RP Giugliano, AC Keech, PS Sever, SA Murphy and TR Pedersen, for the FOURIER Steering Committee & Investigators
Evolocumab Reduces Cardiovascular Events in Patients with Baseline LDL-C
More informationResults of ODYSSEY OUTCOMES Trial
Results of ODYSSEY OUTCOMES Trial Evaluation of long-term cardiovascular outcomes after Acute Coronary Syndrome (ACS) during treatment with Praluent (alirocumab) Investor call at ACC, Orlando, March 10,
More informationHYPERLIPIDEMIA IN THE OLDER POPULATION NICOLE SLATER, PHARMD, BCACP AUBURN UNIVERSITY, HARRISON SCHOOL OF PHARMACY JULY 16, 2016
HYPERLIPIDEMIA IN THE OLDER POPULATION NICOLE SLATER, PHARMD, BCACP AUBURN UNIVERSITY, HARRISON SCHOOL OF PHARMACY JULY 16, 2016 NOTHING TO DISCLOSE I, Nicole Slater, have no actual or potential conflict
More informationWhats new in lipid management, and Can your high CV risk patients benefit from a PCSK9i?
Whats new in lipid management, and Can your high CV risk patients benefit from a PCSK9i? Copyright 2017 by Sea Courses Inc. All rights reserved. No part of this document may be reproduced, copied, stored,
More informationESC Geoffrey Rose Lecture on Population Sciences Cholesterol and risk: past, present and future
ESC Geoffrey Rose Lecture on Population Sciences Cholesterol and risk: past, present and future Rory Collins BHF Professor of Medicine & Epidemiology Clinical Trial Service Unit & Epidemiological Studies
More informationPlacebo-Controlled Statin Trials Prevention Of CVD in Women"
MANAGEMENT OF HIGH BLOOD CHOLESTEROL: IMPLICATIONS OF THE NEW GUIDELINES Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Declaration of full disclosure: No conflict of interest
More informationPCSK9 Inhibitors: Narnia vs. Medicare Bankruptcy
PCSK9 Inhibitors: Narnia vs. Medicare Bankruptcy Sergio Fazio, MD, PhD William and Sonja Connor Professor of Preventive Cardiology Professor of Medicine, Physiology & Pharmacology Director, Center for
More informationWeigh the benefit of statin treatment: LDL & Beyond
Weigh the benefit of statin treatment: LDL & Beyond Duk-Woo Park, MD, PhD Heart Institute, University of Ulsan College of Medicine, Asan Medical, Seoul, Korea FOURIER Further cardiovascular OUtcomes Research
More informationWhat do the guidelines say about combination therapy?
What do the guidelines say about combination therapy? Christie M. Ballantyne, MD Center for Cardiovascular Disease Prevention Methodist DeBakey Heart & Vascular Center Baylor College of Medicine Houston,
More informationCholesterol; what are the future lipid targets?
Cholesterol; what are the future lipid targets? lipidologist out-of-business in 5-10 years? G.Kees Hovingh dept of vascular medicine, Academic Medical Center g.k.hovingh@amc.uva.nl Disclosure - Consultant
More informationManagement of Lipid Disorders and Hypertension: Implications of the New Guidelines
Management of Lipid Disorders and Hypertension Management of Lipid Disorders and Hypertension: Implications of the New Guidelines Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine
More informationDYSLIPIDEMIA. Michael Brändle, Stefan Bilz
DYSLIPIDEMIA Michael Brändle, Stefan Bilz Cardiovascular risk in patients with DM Current guidelines with emphasis on patients with DM Familial Hypercholesterolemia PCSK9-inhibitors Primary Prevention
More informationBest Lipid Treatments
Best Lipid Treatments Pam R. Taub MD, FACC Director of Step Family Cardiac Rehabilitation and Wellness Center Associate Professor of Medicine UC San Diego Health System Overview of Talk Review of pathogenesis
More information9/18/2017 DISCLOSURES. Consultant: RubiconMD. Research: Amgen, NHLBI OUTLINE OBJECTIVES. Review current CV risk assessment tools.
UW MEDICINE UW MEDICINE UCSF ASIAN TITLE HEALTH OR EVENT SYMPOSIUM 2017 DISCLOSURES Consultant: RubiconMD ESTIMATING CV RISK IN ASIAN AMERICANS AND PREVENTION OF CVD Research: Amgen, NHLBI EUGENE YANG,
More informationManaging Lipids and Cardiovascular Risk: Using the Data to Optimize Care
Emerging Challenges in Primary Care: 2018 Managing Lipids and Cardiovascular Risk: Using the Data to Optimize Care Faculty Ola Akinboboye, MD, MPH, MBA Associate Professor of Clinical Medicine Cornell
More informationEmerging Challenges in Primary Care: Managing Lipids and Cardiovascular Risk: Using the Data to Optimize Care
Emerging Challenges in Primary Care: 2018 Managing Lipids and Cardiovascular Risk: Using the Data to Optimize Care Faculty Ola Akinboboye, MD, MPH, MBA Associate Professor of Clinical Medicine Cornell
More informationManaging Lipids and Cardiovascular Risk: Using the Data to Optimize Care
Emerging Challenges in Primary Care: 2018 Managing Lipids and Cardiovascular Risk: Using the Data to Optimize Care Faculty Ola Akinboboye, MD, MPH, MBA Associate Professor of Clinical Medicine Cornell
More informationNo relevant financial relationships
MANAGEMENT OF LIPID DISORDERS: WHERE DO WE STAND WITH THE NEW PRACTICE GUIDELINES? Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Disclosure No relevant financial relationships
More informationPlacebo-Controlled Statin Trials MANAGEMENT OF HIGH BLOOD CHOLESTEROL MANAGEMENT OF HIGH BLOOD CHOLESTEROL: IMPLICATIONS OF THE NEW GUIDELINES
MANAGEMENT OF HIGH BLOOD CHOLESTEROL: IMPLICATIONS OF THE NEW GUIDELINES Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Declaration of full disclosure: No conflict of interest
More informationCottrell Memorial Lecture. Has Reversing Atherosclerosis Become the New Gold Standard in the Treatment of Cardiovascular Disease?
Cottrell Memorial Lecture Has Reversing Atherosclerosis Become the New Gold Standard in the Treatment of Cardiovascular Disease? Stephen Nicholls MBBS PhD @SAHMRI_Heart Disclosures Research support: AstraZeneca,
More informationDyslipidemia: Lots of Good Evidence, Less Good Interpretation.
Dyslipidemia: Lots of Good Evidence, Less Good Interpretation. G Michael Allan Evidence & CPD Program, ACFP Associate Professor, Dept of Family, U of A. CFPC CoI Templates: Slide 1 Faculty/Presenter Disclosure
More information2013 ACC AHA LIPID GUIDELINE JAY S. FONTE, MD
2013 ACC AHA LIPID GUIDELINE JAY S. FONTE, MD How do you interpret my blood test results? What are our targets for these tests? Before the ACC/AHA Lipid Guidelines A1c:
More information