New Approaches to Lower LDL-C
|
|
- Gwen Newton
- 5 years ago
- Views:
Transcription
1 New Approaches to Lower LDL-C CSIM 27 October 2016 Jacques Genest MD Cardiovascular Health Across the Lifespan Program McGill University Health Center
2 Disclosure J. Genest MD 2016 Advisory Board, Speaker s Bureau, Consultant, Grants, Clinical Trials Merck * Pfizer Novartis AMGEN * Cerenis Sanofi/Regeneron * Lilly Valeant Aegerion RengenXBio CADTH, CDR INESSS EAS, IAS Stock ownership: none; Off label use: none * Scientific Advisory Relevant disclosure: IMPROVE-IT, CANTOS, CAPREE steering Committees; REVEAL, ACCELERATE, AMG145, Sanofi, TANGO, Lilly Clinical Trials.
3 Cell 2015:161;
4 Diagnosis, Prevention and Management of Statin Adverse Effects and Intolerance: Canadian Consensus Working Group Update (2016) G.B. John Mancini, MD, Steven Baker, MD, Jean Bergeron, MD, David Fitchett, MD, Jiri Frohlich, MD, Jacques Genest, MD, Milan Gupta, MD, Robert A. Hegele, MD, Dominic Ng, MD, Glen J. Pearson, PharmD, Janet Pope, MD, A. Yashar Tashakkor, MD Mancini et al, DOI:
5 Clinical Experience vs Randomized Clinical Trials: The Elephant in the Room regarding Goal-Inhibiting Statin Intolerance (GISI) Mancini et al, DOI:
6 GAUSS-3 Statin Intolerance
7 Comparison of Guidelines CCS 2016 EAS/ESC 2016 AHA/ACC LDL-C Targets/Treatment Recommendations Secondary prevention Statin intolerance < 2 mmol/l or > 50% reduction < 1.8 mmol/l or 50% reduction High-intensity statin. (anticipate > 50% reduction) If 50% cannot be achieved, consider additional therapy. Same Same Same Primary prevention LDL > 5 mmol/l Primary prevention in diabetes Primary prevention High risk > 50% reduction < 2.5 mmol/l High-intensity statin therapy (anticipate 50% reduction) < 2 mmol/l or > 50% reduction For FRS >10%: < 2 mmol/l or > 50% decrease High risk DM: 1.8 mmol/l, or at least 50% reduction Low risk DM: < 2.5 mmol/l SCORE 5% risk of fatal CVD: <2.5 mmol/l High risk DM: High-intensity statin Low risk DM: Moderate-intensity statin For PCRAE >7.5%: Moderate- to high-intensity statin
8 Medications for Hypercholesterolemia Statins Ezetimibe Fibrates Niacin BAR PCSK9 mab CETP inh MTP inh ApoB irna Bempedoic Acid
9 PCSK9 LDL-R A: LDL-R pathway in absence of PCSK9 LDL Degradation Lysosome Endosome apob B: Intracellular PCSK9 route PCSK9 pre-pcsk9 C: Extracellular PCSK9 route Mature PCSK9 ER TGN
10 PCSK9 as a Target Cohen JC, et al. NEJM 2006;354:1264
11 LDLR
12 Antibody technology has evolved over past decades Immunogenicity Highly Immunogenic e.g. Abciximab Chimeric, Still very immunogenic e.g. Bococizumab Can be time-consuming to create Red = mouse Blue = human e.g. Evolocumab and Alirocumab repeated dosing possible Fully Mouse 1 st generation Chimeric 2 nd generation Humanized 3 rd generation Fully Human 4 th generation Nomenclature: Prefix (Pharma) C (Cardiovascular) UMAB 12
13
14
15
16
17 ODYSSEY Long-Term: Alirocumab Plus Statin Achieved a 62% Reduction in LDL-C over Placebo+Statin at 24 weeks mmol/l 3.17 mmol/l 0.8% 3.6% Median LDL-C (mmol/l) % reduction, P<0.001 Absolute reduction: 1.2 mmol/l 1.25 mmol/l -61.0% 1.50 mmol/l -52.4% 0.60 Alirocumab + statin therapy at maximum tolerated dose ± other LLT (150 mg q2w) Placebo + statin therapy at maximum tolerated dose ± other LLT No. of patients with data available Week Placebo Alirocumab Robinson J, et al. N Engl J Med. 2015;372(16):
18 ODYSSEY Long-Term: Reduction in the Rate of Cardiovascular Events- Post-hoc Analysis Kaplan-Meier Estimates for Time to First Adjudicated Major CV Event 0.06 Kaplan-Meier Estimates for Time to First Adjudicated Major CV Event* Cumulative probability of event Safety Analysis Cox model analysis HR % CI: 0.26 to 0.82 P<0.01 Alirocumab + max-tolerated statin ± other LLT (150 mg q2w) Placebo + max-tolerated statin ± other LLT 54% RRR 0.00 No. at Risk Placebo Alirocumab Weeks *Primary endpoint for the ODYSSEY OUTCOMES trial: CHD death, Non-fatal MI, Fatal and non-fatal ischemic stroke, Unstable angina requiring hospitalization. LLT, lipid-lowering therapy 52 weeks for all patients continuing treatment, incl. 607 patients who completed W78 visit Robinson J, et al. N Engl J Med. 2015;372(16):
19 Ratio of LDL Lowering to CV Event Reduction with PCSK9 Inhibitors Holds True to the LDL Hypothesis 70% 60% Proportional reduction in event rate (SE) 50% 40% 30% 20% 10% IMPROVE-IT ODYSSEY Long-Term OSLER 0% -10% Reduction in LDL cholesterol (mmol/l) Waters DD. Hsue PY. Circ Res. 2015;16:
20 Bococizumab Christie M. Ballantyne, et al. Results of Bococizumab, A Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, from a Randomized, Placebo-Controlled, Dose-Ranging Study in Statin-Treated Subjects With Hypercholesterolemia The American Journal of Cardiology, Volume 115, Issue 9, 2015,
21 PCSK9 Outcome Trials Alirocumab Evolocumab Bococizumab Trial ODYSSEY Outcomes (secondary prevention) FOURIER (secondary prevention) SPIRE1 (secondary prevention) SPIRE2 (primary prevention) No of patients 18,600 27,500 17,000 10,600 Dosage s/c, Q2W s/c, Q2W or Q4W s/c, Q2W s/c, Q2W Start date Oct 2012 Jan 2013 Oct 2013 Oct 2013 Expected End date Q1 2017? Primary endpoint Mar 2018 Feb 2018 Aug 2017 Aug 2017 CHD death non-fatal MI fatal and non-fatal ischemic stroke high risk UA requiring hospitalization CV death MI Stroke hospitalization for UA coronary revascularization CV death non-fatal MI non-fatal stroke hospitalization for UA needing urgent revascularization CV death non-fatal MI non fatal stroke hospitalization for UA needing urgent revascularization Duration Up to Month 64 Up to 5 years Up to Month 60 Up to Month 60 Population Patients 4 to 52 wks post High risk patients ACS LDL-C 70 (1.8) and LDL-C 70 (1.8) <100 (2.6) or History of clinically evident CVD: MI, stroke or symptomatic PAD and 1 major RF or 2 minor RFs LDL-C 70 (1.8) or High risk subjects LDL-C 100 (2.6) or 73,700 patients
22 Anti-drug antibodies (ADA): the challenge Immunogenicity: The potential for an antigen to induce an immune response Immunogenicity against therapeutic proteins that are not in the normal human repertoire is a normal immune response. Reaction to neo-antigens Proteins are non-human Fusion proteins create new epitopes Unusual glycosylation Anti-drug antibody formation Antibody Fab (Neutralizing) Anti-PSCK9 Antibody Fc
23 PCSK9 RNAi Lancet 383;9911, 60 68
24 PCSK9 mab Clinical Indications Familial Hypercholesterolemia ASCVD (Atherosclerotic Cardiovascular Disease) not at goal despite maximally tolerated lipid-lowering therapy Statin intolerant
25
26 CETPinh Torcetrapib: off-target effects (?) increase MACE Dalcetrapib: HDL elevation but no LDL-C lowering: no effect on MACE Anacetrapib: Decrease in LDL-C overestimated by Friedewald formula; effect size smaller. Concerns with prolonged terminal half-life Evacetrapib. Decrease in LDL-C overestimated by Friedewald formula; effect size smaller. Shorter terminal T 1/2 but still prolonged Orocetrapib (TA-8995) TULIP trial reported 2015
27 Medications for Hypercholesterolemia Statins Ezetimibe Fibrates Niacin BAR PCSK9 mab CETP inh MTP inh ApoB irna Bempedoic Acid
28 VLDL Assembly and secretion Mipomersen Lomatipibe 28
29 (Juxtapid ) 29
30 Lomatipide and Homozygous FH
31 Bempedoic Acid Esperion ETC 1002 Bempedoic acid inhibits ATP-citrate lyase (ACL)
32 Bempedoic Acid Esperion ETC 1002
33 In Conclusion PCSK9 inhibitors hold great promise for the treatment of severe LDL-C elevation Clinical trials are underway to determine if PCSK9inh reduce ASCVD CETPinh (Anacetrapib) is tested in the REVEAL trial and results are expected in 2017
34
35 Extracorporeal LDL Filtration
36 Liposorber (Kaneka) HELP (Braun)
37 Courtoisie Dr Jean Bergeron
38 Extracorporeal LDL Filtration (HELP) Mean LDL-C (mmol/l) Apheresis + Atorvastatin Mean LDL-C (mg/dl) Time (years) Genest J. NEJM 1999;341:490
39 A B C D
Making 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 informationPaul Ehrlich and PCSK9 inhibition: A Magic Bullet for CVD prevention?
Paul Ehrlich and PCSK9 inhibition: A Magic Bullet for CVD prevention? Jacques Genest MD Cardiovascular Research Laboratories McGill University Health Center Endocrinology Rounds 19 Nov 2015 Disclosure
More informationCanadian Lipid Guidelines, a Century of Cholesterol and PCSK9inh
Canadian Lipid Guidelines, a Century of Cholesterol and PCSK9inh Jacques Genest MD Cardiovascular Research Laboratories McGill University Health Center McGill Refresher Course Dec 5, 2016 Disclosure J.
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 informationCanadian Lipid Guidelines, a Century of Cholesterol and Paul Erlich
Canadian Lipid Guidelines, a Century of Cholesterol and Paul Erlich Jacques Genest MD Cardiovascular Research Laboratories McGill University Health Center Endocrinology Rounds 19 Nov 2015 Disclosure J.
More informationThe Target is LDL, HDL not so much
The Target is LDL, HDL not so much HDL: A riddle wrapped in a mystery inside an enigma Jacques Genest MD Cardiovascular Research Laboratories McGill University Health Center Disclosure J. Genest MD 2013
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 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 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 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 informationWhat 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 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 informationPCSK9 Inhibitors Current Status
PCSK9 Inhibitors Current Status Ryan T. Whitney, MD FACC Bryan Heart Spring Conference 2016 Disclosures, Conflicts, and Nefarious Connections I own no stock in the companies mentioned in this talk. I am
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 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 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 informationPCSK9 Inhibitors Current Status
PCSK9 Inhibitors Current Status Ryan T. Whitney, MD FACC Bryan Heart Fall Conference 2015 Disclosures, Conflicts, and Nefarious Connections I own no stock in the companies mentioned in this talk. I am
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 informationPCSK9 antibodies: A new therapeutic option for the treatment of hypercholesterolemia
: 262-267, 2017 Περίληψη Διάλεξης PCSK9 antibodies: A new therapeutic option for the treatment of hypercholesterolemia I. Gouni-Bethold Polyclinic for Endocrinology, Diabetes, and Preventive Medicine University
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 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 informationNovel PCSK9 Outcomes. in Perspective: Lessons from FOURIER & ODYSSEY LDL-C. ASCVD Risk. Suboptimal Statin Therapy
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,
More informationEffect of the PCSK9 Inhibitor Evolocumab on Cardiovascular Outcomes
Effect of the PCSK9 Inhibitor Evolocumab on Cardiovascular Outcomes MS Sabatine, RP Giugliano, SD Wiviott, FJ Raal, CM Ballantyne, R Somaratne, J Legg, SM Wasserman, R Scott, MJ Koren, and EA Stein for
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 informationBeyond HDL: new therapeutic targets
Rome Cardiology Forum 2014 An ESC Update Programme in Cardiology Rome, 29-31 2014 Beyond HDL: new therapeutic targets Marcello Arca, MD Dipartimento di Medicina Interna e Specialità Mediche UOS Centro
More informationHyperlipidemia Guidelines: What s New in 2015? Eva Lonn, MD, MSc Professor of Medicine
Hyperlipidemia Guidelines: What s New in 2015? Eva Lonn, MD, MSc Professor of Medicine The new england journal of medicine Original Article Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes
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 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 informationEVIDENCE TO DATE EVOLOCUMAB (REPATHA)
and Clinical Outcomes in Patients with Cardiovascular Disease, March 2017 1 CLINICAL QUESTION In patients with atherosclerotic cardiovascular disease and LDL >1.8mmol/L or non-hdl > 2.6mmol/L, how does
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 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 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 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 informationIndicações para um inibidor de PCSK9
Indicações para um inibidor de PCSK9 Renato D. Lopes, MD MHS PhD Professor of Medicine Division of Cardiology Duke Clinical Research Institute Duke University Medical Center 1987 2017: 30 years since first
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 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 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 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 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 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 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 informationCharacterization of Types and Sizes of Myocardial Infarction Reduced with Evolocumab in FOURIER
Characterization of Types and Sizes of Myocardial Infarction Reduced with Evolocumab in FOURIER Stephen D Wiviott, Robert P Giugliano, David A Morrow, Gaetano M De Ferrari, Basil S Lewis, Kurt Huber, Julia
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 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 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 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 informationEffect of alirocumab on the frequency of lipoprotein apheresis: A randomised Phase III trial
Effect of alirocumab on the frequency of lipoprotein apheresis: A randomised Phase III trial Patrick M. Moriarty, Klaus G. Parhofer, Stephan P. Babirak, Marc-Andre Cornier, P. Barton Duell, Bernd Hohenstein,
More informationPCSK9 inhibition across a wide spectrum of patients: One size fits all?
PCSK9 inhibition across a wide spectrum of patients: One size fits all? PACE ESC Barcelona 2017 G.K. Hovingh MD PhD MBA dept of vascular medicine Academic Medical Center the Netherlands g.k.hovingh@amc.uva.nl
More informationPCSK9 Inhibitors for Lowering Cholesterol: Ready for Prime Time?
Original Article Thomas Knickelbine, MD, FACC, FSCCT, FSCAI From: Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, MN Address for correspondence: Thomas Knickelbine, MD, FACC,
More informationHYPERCHOLESTEROLEMIA
UPDATES ON HYPERCHOLESTEROLEMIA WITH EMPHASIS ON PCSK9 INHIBITORS July, 2018 Chicago by Ernesto L. Chua, MD, FACC, FACP, FPCP Board Certified in Internal Medicine Board Certified in Cardiology COL, USAF,
More informationDrug Class Review Proprotein Convertase Subtilisin Kexin type 9 (PCSK9) Inhibitors
Drug Class Review Proprotein Convertase Subtilisin Kexin type 9 (PCSK9) Inhibitors Final Original Report July 2015 The purpose of reports is to make available information regarding the comparative clinical
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 informationClinical Efficacy and Safety of Achieving Very Low LDL-C Levels With the PCSK9 Inhibitor Evolocumab in the FOURIER Outcomes Trial
Clinical Efficacy and Safety of Achieving Very Low LDL-C Levels With the PCSK9 Inhibitor Evolocumab in the FOURIER Outcomes Trial RP Giugliano, TR Pedersen, AC Keech, PS Sever, JG Park, and MS Sabatine,
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Proprotein Convertase Subtilisin/kexin type 9 Page 1 of 24 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Proprotein Convertase Subtilisin/kexin type 9 (PCSK9)
More informationPCSK9 and its Role in LDL Receptor Regulation Muscat, Oman - 9 February 2019
PCSK9 and its Role in LDL Receptor Regulation Muscat, Oman - 9 February 2019 Professor Gilles Lambert, PhD LaboratoireInserm U1188 Universitéde la Réunion Faculté de Médecine Saint Denis de la Réunion,
More informationPCSK9 Inhibitors: A View of Clinical Studies
PCSK9 Inhibitors: A View of Clinical Studies Slide deck kindly donated for website use by Professor Raul D. Santos Lipid Clinic InCor-HCFMUSP Sao Paulo, Brazil PCSK9 Inhibitors : A View of Clinical Studies
More informationInvestigator Meeting. Monday, September 12, 2016
Investigator Meeting Monday, September 12, 2016 Principal Investigators Milan Gupta, MD, FRCPC, FACC Associate Clinical Professor of Medicine, McMaster University Brampton, ON Steering Committee David
More informationDyslipidemia Treatment in 2016 Novel Agents Combination Therapies Statin Intolerance
Dyslipidemia Treatment in 2016 Novel Agents Combination Therapies Statin Intolerance Hani Sabbour MD FACC FHRS Clinical Assistant Professor of Cardiology Brown University Rhode Island USA Consultant Cardiology
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 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 informationThe ACCELERATE Trial
The ACCELERATE Trial Impact of the Cholesteryl Ester Transfer Protein Inhibitor Evacetrapib on Cardiovascular Outcome Stephen J Nicholls for the ACCELERATE investigators Disclosure Research support: AstraZeneca,
More informationCCC Dyslipidemia Lipid lowering/atherosclerosis clinical trials update. November 17 th, 2018
CCC Dyslipidemia Lipid lowering/atherosclerosis clinical trials update November 17 th, 2018 Faculty/Presenter Disclosure Faculty: Rick Ward Relationships with commercial interests: Grants/Research Support:
More informationCETP inhibition: pros and cons. Philip Barter The Heart Research Institute Sydney, Australia
CETP inhibition: pros and cons Philip Barter The Heart Research Institute Sydney, Australia Philip Barter Disclosures Received honorariums for lectures, consultancies or membership of advisory boards from:
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 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 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 informationChallenges in lipid management
Challenges in lipid management Milan Gupta MD, FRCPC, FACC State of the Heart Co-Chair Associate Clinical Professor of Medicine, McMaster University Assistant Professor of Medicine, University of Toronto
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 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 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 informationPCSK9 for LDL Cholesterol Reduction: What have we learned from clinical trials?
PCSK9 for LDL Cholesterol Reduction: What have we learned from clinical trials? Slide deck kindly supplied as an educational resource by Dr Evan A Stein MD PhD Director Emeritus Metabolic & Atherosclerosis
More informationWorkshop. Todd Anderson MD / Jacques Genest MD
Workshop Todd Anderson MD / Jacques Genest MD Game-Changing Trials 2017 FOURIER Evolocumab n=27,564 HR 0.80 CANTOS Canakinumab n=10,061 HR 0.85 COMPASS Rivaroxaban + ASA n=27,395 HR 0.76 Key Secondary
More informationCholesterol Reduction Therapy in 2018 A Perspective Role Of Statins, Ezetimibe and PCSK9-Inhibitors
USC-April 21, 2018, Los Angeles Cholesterol Reduction Therapy in 2018 A Perspective Role Of Statins, Ezetimibe and PCSK9-Inhibitors P.K.Shah, MD, MACC Shapell and Webb Chair in Clinical Cardiology, Director,
More informationInhibition of PCSK9: The Birth of a New Therapy
Inhibition of PCSK9: The Birth of a New Therapy Prof. John J.P. Kastelein, MD PhD FESC Dept. of Vascular Medicine Academic Medical Center / University of Amsterdam The Netherlands Disclosures Dr. Kastelein
More informationDavid Y. Gaitonde, MD, FACP Endocrinology DDEAMC, Fort Gordon
David Y. Gaitonde, MD, FACP Endocrinology DDEAMC, Fort Gordon I have no actual or potential conflicts of interest in relation to this program or presentation. Raphael School of Athens, 1509-1511 Apply
More informationS3-13: Lipids: Looking forward to
S3-13: Lipids: Looking forward to 2018 Heart and Stroke Clinical Update 1010-1140 9 Dec 2017 Robert Hegele MD, FRCPC, FACP Distinguished University Professor Endocrinologist, University Hospital Western
More informationProprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit Program Summary
Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit Program Summary Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization
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 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 informationNew Drugs for Lipid Management
New Drugs for Lipid Management John Larry, MD Assistant Professor-Clinical Section Chief, OSU East Cardiovascular Medicine Department of Internal Medicine Division of Cardiovascular Medicine The Ohio State
More informationNew Drugs for Lipid Management
New Drugs for Lipid Management John Larry, MD Assistant Professor-Clinical Section Chief, OSU East Cardiovascular Medicine Department of Internal Medicine Division of Cardiovascular Medicine The Ohio State
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 information51 e CONGRES DE L A.M.U.B.
51 e CONGRES DE L A.M.U.B. ACTUALITES THERAPEUTIQUES EN LIPIDOLOGIE Dr. P. VAN DE BORNE Cardiologue Service de Cardiologie ULB- Hôpital Erasme Session ACTUALITES DIAGNOSTIQUES ET THERAPEUTIQUES Modérateurs
More informationApproach to Dyslipidemia among diabetic patients
Approach to Dyslipidemia among diabetic patients Farzad Hadaegh, MD, Professor of Internal Medicine & Endocrinology Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences
More informationTHE CRUCIAL PROBLEM OF ASCVD Can New Therapeutic Options Resolve It? THE CRUCIAL PROBLEM OF ASCVD Can New Therapeutic Options Resolve It?
James A. Underberg, MD, MS, FACPM, FACP, FNYAM, FASPC, FNLA Lipidology and Cardiovascular Disease Prevention Clinical Assistant Professor of Medicine NYU Medical School and NYU Center for CV Prevention
More informationProblem patients in primary care Patient 4: Peripheral artery disease
Problem patients in primary care Patient 4: Peripheral artery disease Dr Terry McCormack Hambleton Richmond Whitby Clinical Commissioning Group Research Lead 01/05/2014 Delivering clinical research to
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 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 informationFamilial Hypercholesterolemia New treatments
Familial Hypercholesterolemia New treatments Prof. Shlomo Keidar Head Internal Medicine A Rambam Health Care Campus IAS, Haifa May 2013 Effect of treatment on CV survival in Familial Hypercholesterolemia
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 informationMarshall Tulloch-Reid, MD, MPhil, DSc, FACE Epidemiology Research Unit Tropical Medicine Research Institute The University of the West Indies, Mona,
Marshall Tulloch-Reid, MD, MPhil, DSc, FACE Epidemiology Research Unit Tropical Medicine Research Institute The University of the West Indies, Mona, Jamaica At the end of this presentation the participant
More informationDrug Class Prior Authorization Criteria PCSK9 Inhibitors
Drug Class Prior Authorization Criteria PCSK9 Inhibitors Line of Business: Medicaid P & T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of
More informationFasting or non fasting?
Vascular harmony Robert Chilton Professor of Medicine University of Texas Health Science Center Director of Cardiac Catheterization labs Director of clinical proteomics Which is best to measure Lower continues
More informationCardiology 2015: Status On Pharmacology News, Debates & Novelties
Cardiology 2015: Status On Pharmacology News, Debates & Novelties George D. Dangas, MD, FESC, FACC Professor of Medicine (Cardiovascular Disease) Icahn School of Medicine at Mount Sinai Zena & Michael
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 informationJoslin Diabetes Center Advances in Diabetes and Thyroid Disease 2013 Consensus and Controversy in Diabetic Dyslipidemia
Consensus and Controversy in Diabetes and Dyslipidemia Om P. Ganda MD Director, Lipid Clinic Joslin diabetes Center Boston, MA, USA CVD Outcomes in DM vs non- DM 102 Prospective studies; 698, 782 people,
More information2/10/2016. Perspectives on the 2013 ACC/AHA Cholesterol Guidelines. Disclosures. ATP-III Update 2004
Perspectives on the 2013 ACC/AHA Cholesterol Guidelines Donald M. Lloyd-Jones, MD ScM Senior Associate Dean Chair and Professor of Preventive Medicine Northwestern Feinberg School of Medicine Disclosures
More informationW J C. World Journal of Cardiology. PCSK9 inhibitors: A new era of lipid lowering therapy. Abstract REVIEW
W J C World Journal of Cardiology Submit a Manuscript: http://www.wjgnet.com/esps/ DOI: 10.4330/wjc.v9.i2.76 World J Cardiol 2017 February 26; 9(2): 76-91 ISSN 1949-8462 (online) REVIEW PCSK9 inhibitors:
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 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 information