Making War on Cholesterol with New Weapons: How Low Can We/Should We Go? Shaun Goodman
|
|
- Dayna Stevenson
- 5 years ago
- Views:
Transcription
1 Making War on Cholesterol with New Weapons: How Low Can We/Should We Go? Shaun Goodman
2 Disclosures Research grant support, speaker/consulting honoraria: Sanofi and Regeneron Including ODYSSEY Outcomes trial Executive Steering Committee member and Canadian National Coordinator; Co-Director of the Canadian VIGOUR Centre (CVC; Canadian ARO) Amgen Lilly Including Guidelines Oriented Approach to Lipid lowering (GOAL) in Canada Steering Committee member; Consultant to the Canadian Heart Research Centre (CHRC; Canadian ARO) ACCELERATE and LY trials Steering Committee member AstraZeneca, Bristol-Myers Squibb, Merck, Pfizer Additional relationships (research grant support, speaker/consulting honoraria) with commercial interests but not relevant to this presentation
3 Proportional Reduction in Incidence of Major Coronary and Vascular Events and Mean Absolute LDL Reduction at 1 Year 50% 40% 30% Major Coronary Events n=90,056 23% proportional reduction per mmol/l LDL cholesterol reduction 50% 40% 30% Major Vascular Events 14 randomized trials 21% proportional reduction per mmol/l LDL cholesterol reduction 20% 20% 10% 10% 12% proportional reduction in 0% All-cause Mortality 0% per mmol/l LDL cholesterol reduction -10% -10% Reduction in LDL cholesterol (mmol/l) Reduction in LDL cholesterol (mmol/l) The greater the reduction in LDL, the greater the reduction in risk of major Cholesterol Treatment coronary Trialists and (CTT) vascular Collaborators events Lancet 2005;366:
4 Risk Assessment, Stratification & Treatment Consideration Anderson et al Can J Cardiol 2016;doi: /j.cjca
5 LDL-Cholesterol Treatment Targets: Not Always So Easy to Hit
6 Risk Assessment, Stratification & Treatment Consideration Anderson et al Can J Cardiol 2016;doi: /j.cjca
7 Persistent LDL-C Above Guideline-Recommended Target Despite Maximally Tolerated High Intensity Statin: Which Add-On Therapy Do You Choose? Lipid-Modifying Class Principal effects Other considerations Bile Acid Sequestrants LDL-C % Fibrates Niacin LDL-C 5-20 % Lowers TG Variable effect on HDL-C LDL-C 20 % TG 40 % HDL-C 30 %? CV outcome GI intolerability, benefit may when elevate added TG to statin Colesevelam better tolerated than 1st generation BAS, has A1C lowering effect More effective at raising HDL-C when baseline TG is high No CV outcome benefit when added to statin Flushing/pruritus may limit tolerance, can cause dose-related deterioration of glycemic control No CV outcome benefit when added to statin Ezetimibe LDL-C % Well tolerated CV outcome benefit in addition to simvastatin Adapted from Anderson et al Can J Cardiol 2013;29: and Mancini et al Can J Diabet 2013;37: S110-6
8 Primary Endpoint: CV Death, MI, UA Requiring Rehospitalization, Coronary Revascularization, or Stroke Pts 50 yrs hospitalized for ACS<10 days with 1 high risk feature and LDL-C >1.3 mmol/l Baseline mean 2.4 mmol/l Simvastatin 1.8 mmol/l Simva+Ezetimibe 1.4 mmol/l CV Death/Stroke/MI: 22% vs. 20%, p=0.003 Simvastatin 35% 33% Ezetimibe/ Simvastatin HR 0.94 (0.89, 0.99), p=0.016 NNT= 50 Cannon et al N Engl J Med 2015;372:
9 Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors The Canadian Medical Post March 26, 2013
10 Impact of a PCSK9 Monoclonal Antibody on LDL Receptor Expression
11 Statins and Other Lipid-Lowering Therapies: Impact on PCSK9 Major classes of commonly prescribed lipid-lowering medications appear to increase serum PCSK9 levels Statins cause a modest (10%-50%) upregulation of PCSK9 May explain the less than expected incremental LDL- C lowering from increasing doses of statin; i.e., ~ 6% additional LDL-C reduction with each doubling of statin dose Konrad et al Lipids Health Dis 2011;10:38
12 PCSK9 Inhibitors: Phase III Programs Dadu & Ballantyne et al Nat Rev Cardiol 2014;11;563-75
13 PCSK9 Inhibition: Dramatic and Persistent Lowering of LDL-Cholesterol Baseline LDL-C 3.10 mmol/l ~61-62% Relative, Absolute mmol/l Reduction in LDL-C Robinson et al N Engl J Med 2015;372: Sabatine et al N Engl J Med 2015;372:1500-9
14 Promising Impact on Cardiovascular Outcomes Post hoc analysis: CHD death, Non-fatal MI, Fatal and non-fatal ischemic stroke, Unstable angina requiring hospitalization HR 0.52 ( ) p 0.01 n=788 n=1550 Prospective exploratory analysis: CV Death, MI, Unstable angina requiring hospitalization, Coronary revascularization, Stroke/TIA, Heart failure requiring hospitalization HR 0.47 ( ) p=0.003 n=1489 n=2976 Weeks Days Robinson et al N Engl J Med 2015;372: Sabatine et al N Engl J Med 2015;372:1500-9
15 <100 mg/dl (2.6 mmol/l) <70 mg/dl (1.8 mmol/l) LDL-C Goal at 12 weeks Sabatine et al N Engl J Med 2015;372:1500-9
16 Alirocumab Safety Summary Pooled Alirocumab Phase 2/3 Placebo-control studies % of patients Alirocumab (N=2476) Placebo (N=1276) Treatment Emergent (TE) AEs (%) TEAEs leading to discontinuation (%) 5 5 Any skeletal-muscle related TEAE (%) Skeletal-muscle related TEAE leading to discontinuation (%) Potential general allergic events 9 8 Neurocognitive events TE diabetes and worsening of preexisting diabetes (%) 4 4 Local injection site reaction (%) 7 HR 1.48 ( ) 5 Local injection site reaction leading to discontinuation (%) TEAE period = time from first to last injection of study treatment + 70 days Pre-defined category including myalgia, muscle spasms, muscular weakness, musculoskeletal stiffness, muscle fatigue n=3,752; 9 trials, median 62 (8-78) weeks duration; >4,000 patient-yrs Adapted from Jones et al J Am Coll Cardiol 2015;65:A372
17 PCSK9 Inhibitors vs. No PCSK9 Inhibitors 24 RCTs (n=10,159) Mean LDL-C reduction 47% (25%-70%) Event n All-cause Mortality 40 Cardiovascular Mortality Myocardial Infarction Unstable Angina Creatine Kinase Increase Serious Adverse Event Events Odds Ratio & 95% CI 0.50 ( ) p= ( ) p= ( ) p= ( ) p= ( ) p= ( ) p=0.88 PCSK9i 1 (%) No PCSK9i 2 (%) Tests for heterogeneity, p=ns PCSK9 Inhibitor Better No PCSK9 Inhibitor Better 1 PCSK9i (n=6187) and 2 No PCSK9i (n=3972); except 3 (n=3289/1906) and 4 (n=2515/1379) Navarese et al Ann Intern Med 2015;163:40-51
18 PCSK9 Inhibitor CV Outcomes Trials PCSK9i Sponsor Trial Evolocumab Amgen FOURIER 1 Alirocumab Sanofi/Regeneron ODYSSEY Outcomes 2 Bococizumab Pfizer SPIRE-1/-2 3 n= Patients Statin (mg) LDL (mmol/l) Primary Endpoint Recruitment Completion 27, yrs+mi, isch stroke, or PAD+CV risk factor(s) atorva 20 or equiv 1.8 (or non-hdl 2.6) CV death, MI, stroke, hosp for UA, revasc June , wks post-acs atorva or rosuva (or non-hdl 2.6 or ApoB 0.8 g/l) CHD death, MI, isch stroke, hosp for UA Nov ,000/11,000 High risk 1º/2º prevention atorva 40-80, rosuva 20-40, simva or partial/comp statin intol 1.8/2.6 (or non- HDL 2.6/3.4) CV death, MI, stroke, hosp for UA + revasc ongoing/mar / Sabatine et al Am Heart J 2016;173:94-101; 2 Schwartz et al Am Heart J 2014;168: e1; 3 Ridker et al Am Heart J 2016;178:
19 Evolocumab (Repatha ) and Alirocumab (Praluent ) Primary Hyperlipidemia REPATHA and PRALUENT are indicated as an adjunct to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C). The effects of REPATHA and PRALUENT on cardiovascular morbidity and mortality have not been determined.
20 Who Might Receive Additional Lipid-Modifying Therapy? Patient Population FH and CAD FH not at goal Estimated number of Canadians ~10,000 ~10,000 CAD not at goal ~250,000 High risk not at goal >250,000?1,500,000 Adapted from Jacques Genest
21 Risk Assessment, Stratification & Treatment Consideration Anderson et al Can J Cardiol 2016;doi: /j.cjca
22
Contemporary 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 informationAlirocumab for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia
Alirocumab for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia Lead author: Stephen Erhorn Regional Drug & Therapeutics Centre (Newcastle) November 2015 2015 Summary Alirocumab (Praluent,
More informationPatient Lists. Epic ABOUT THIS GUIDE INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION. Please see accompanying full Prescribing Information
ABOUT THIS GUIDE This Guide provides a high-level overview of Patient Lists in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for PRALUENT
More informationCommon Repatha Documentation Requirements for Patients With Primary Hyperlipidemia and Established CVD 1,2
Established CVD Common Repatha Documentation Requirements for Patients With Primary Hyperlipidemia and Established CVD 1,2 Primary and Secondary Diagnosis Codes Primary Diagnosis: Primary hyperlipidemia
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 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 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 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 informationNon-Statin Lipid-Lowering Agents M Holler - Last updated: 10/2016
Drug/Class Cholestyramine (Questran) Bile acid sequestrant Generic? Lipid Effects Y/N (monotherapy) Y LDL : 9% (4 g to 8 ; 21% (16 g to 20 ; 23% to 28% (>20 HDL : 4% to 8% (16 to 24 TG : 11% to 28% (4
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 informationPatient List Inquiries
ABOUT THIS GUIDE This Guide provides a high-level overview of Patient List Inquiries in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for
More informationADMINISTRATIVE POLICY AND PROCEDURE
ADMINISTRATIVE POLICY PROCEDURE Policy #: Subject: PCSK9 INHIBITS (ex: Repatha) Section: Care Management Effective Date: January 1, 2015 Revision Date(s): NA Review Date(s): NA Responsible Parties: Patryce
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 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 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 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 informationLipids & Hypertension Update
Lipids & Hypertension Update No financial disclosures Michael W. Cullen, MD, FACC Senior Associate Consultant, Assistant Professor of Medicine Mayo Clinic Department of Cardiovascular Diseases 34 th Annual
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 informationRepatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.16.08 Subject: Repatha Page: 1 of 8 Last Review Date: September 18, 2015 Repatha Description Repatha
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 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 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 informationPatient Action Sets. Allscripts Touchworks ABOUT THIS GUIDE INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION
ABOUT THIS GUIDE This Guide provides a high-level overview of Patient Action Sets in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for PRALUENT
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 informationCopyright 2017 by Sea Courses Inc.
Diabetes and Lipids 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 by any means graphic, electronic, or
More informationPatient Lists. Allscripts Professional ABOUT THIS GUIDE INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION
ABOUT THIS GUIDE This Guide provides a high-level overview of Patient Lists in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for PRALUENT
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 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 informationACC/AHA Guidelines for Cardiovascular Disease Prevention and Cholesterol Management: Implications of New Therapeutic Agents a
Cardiovascular Innovations and Applications Vol. 1 No. 4 (2016) 399 408 ISSN 2009-8618 DOI 10.15212/CVIA.2016.0026 REVIEW ACC/AHA Guidelines for Cardiovascular Disease Prevention and Cholesterol Management:
More informationResults of the GLAGOV Trial
Results of the GLAGOV Trial Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound Steven E. Nissen MD Stephen J. Nicholls MBBS PhD Consulting: Many companies
More informationRandomized Comparison of the Safety, Tolerability, and Efficacy of Long-term Administration of AMG 145: 52-Week Results From the OSLER Study
Randomized Comparison of the Safety, Tolerability, and Efficacy of Long-term Administration of AMG 145: 52-Week Results From the OSLER Study Michael J Koren 1, Robert P Giugliano 2, Frederick Raal 3, David
More informationRepatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.08 Subject: Repatha Page: 1 of 8 Last Review Date: December 2, 2016 Repatha Description Repatha (evolocumab)
More informationPraluent (alirocumab)
Praluent (alirocumab) Policy Number: 5.01.600 Last Review: 06/2018 Origination: 07/2015 Next Review: 06/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Praluent
More informationREPATHA (PCSK9 INHIBITORS)
REPATHA (PCSK9 INHIBITS) Indications: PCSK9 Inhibitors are indicated for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease as
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 informationEfficacy and Safety of Alirocumab in Patients with Hypercholesterolemia not on Statin Therapy: the ODYSSEY CHOICE II Study
Efficacy and Safety of Alirocumab in Patients with Hypercholesterolemia not on Statin Therapy: the ODYSSEY CHOICE II Study Erik Stroes, 1 John Guyton, 2 Michel Farnier, 3 Norman Lepor, 4 Fernando Civeira,
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 informationThe Clinical Unmet need in the patient with Diabetes and ACS
The Clinical Unmet need in the patient with Diabetes and ACS Professor Kausik Ray (UK) BSc(hons), MBChB, MD, MPhil, FRCP (lon), FRCP (ed), FACC, FESC, FAHA Diabetes is a global public health challenge
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 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 informationRepatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.08 Subject: Repatha Page: 1 of 9 Last Review Date: September 15, 2017 Repatha Description Repatha
More informationAdvanced Treatment of LDL: How Low Should You Go?
Advanced Treatment of LDL: How Low Should You Go? C. Michael White, Pharm.D., FCP, FCCP Professor and Head, Pharmacy Practice, UCONN Co-Director, HOPE Collaborative Group, UCONN/Hartford Hospital Potential
More informationAdvanced Treatment of LDL: How Low Should You Go?
Advanced Treatment of LDL: How Low Should You Go? C. Michael White, Pharm.D., FCP, FCCP Professor and Head, Pharmacy Practice, UCONN Co-Director, HOPE Collaborative Group, UCONN/Hartford Hospital Potential
More informationHMG-CoA reductase inhibitors, or statins, have been the
SYSTEMATIC REVIEW A Systematic Review of PCSK9 Inhibitors Alirocumab and Marian McDonagh, PharmD; Kim Peterson, MS; Brittany Holzhammer, MPH; and Sergio Fazio, MD, PhD ABSTRACT BACKGROUND: The proprotein
More informationRepatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.08 Subject: Repatha Page: 1 of 9 Last Review Date: November 30, 2018 Repatha Description Repatha (evolocumab)
More informationEfficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies
Efficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies Michael J. Koren, 1 Evan A. Stein, 2 Eli M. Roth, 3 James M. McKenney, 4 Dan Gipe,
More informationJMP 2017 Life Sciences Conference. Tim Mayleben
JMP 2017 Life Sciences Conference Tim Mayleben PRESIDENT AND CEO JUNE 21, 2017 Safe Harbor Forward-Looking Statements These slides and the accompanying oral presentation contain forward-looking statements
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 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 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 information