Hyperlipidemia Guidelines: What s New in 2015? Eva Lonn, MD, MSc Professor of Medicine
|
|
- Neil Collins
- 6 years ago
- Views:
Transcription
1 Hyperlipidemia Guidelines: What s New in 2015? Eva Lonn, MD, MSc Professor of Medicine
2 The new england journal of medicine Original Article Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes Christopher P. Cannon, M.D., Michael A. Blazing, M.D., Robert P. Giugliano, M.D., Amy McCagg, B.S., Jennifer A. White, M.S., Pierre Theroux, M.D., Harald Darius, M.D., Basil S. Lewis, M.D., Ton Oude Ophuis, M.D., Ph.D., J. Wouter Jukema, M.D., Ph.D., Gaetano M. De Ferrari, M.D., Witold Ruzyllo, M.D., Paul De Lucca, Ph.D., KyungAh Im, Ph.D., Erin A. Bohula, M.D., D.Phil., Craig Reist, Ph.D., Stephen D. Wiviott, M.D., Andrew M. Tershakovec, M.D., M.P.H., Thomas A. Musliner, M.D., Eugene Braunwald, M.D., and Robert M. Califf, M.D., for the IMPROVE-IT Investigators* This article was published on June 3, 2015, at NEJM.org. N Engl J Med 2015;372: DOI: /NEJMoa
3 Study Design Patients stabilized post ACS 10 days: LDL-C *mg/dL (or **mg/dL if prior lipid-lowering Rx) *3.2mM **2.6mM N=18,144 Standard Medical & Interventional Therapy Simvastatin 40 mg Uptitrated to Simva 80 mg if LDL-C > 79 (adapted per FDA label 2011) Ezetimibe / Simvastatin 10 / 40 mg Follow-up Visit Day 30, every 4 months 90% power to detect ~9% difference Duration: Minimum 2 ½-year follow-up (at least 5250 events) Primary Endpoint: CV death, MI, hospital admission for UA, coronary revascularization ( 30 days after randomization), or stroke Cannon CP AHJ 2008;156:826-32; Califf RM NEJM 2009;361:712-7; Blazing MA AHJ 2014;168:205-12
4 LDL-C and Lipid Changes 1 Yr Mean LDL-C TC TG HDL hscrp Simva EZ/Simva Δ in mg/dl Median Time avg 69.5 vs mg/dl
5 Primary Endpoint ITT Cardiovascular death, MI, documented unstable angina requiring rehospitalization, coronary revascularization ( 30 days), or stroke HR CI (0.887, 0.988) p=0.016 Simva 34.7% 2742 events NNT= 50 EZ/Simva 32.7% 2572 events 7-year event rates
6 Individual Cardiovascular Endpoints and CVD/MI/Stroke HR Simva* EZ/Simva* p-value All-cause death CVD CHD MI Stroke Ischemic stroke Cor revasc 30d UA CVD/MI/stroke Ezetimibe/Simva Better Simva Better *7-year event rates (%)
7 CV Death, Non-fatal MI, or Non-fatal Stroke HR 0.90 CI (0.84, 0.97) p=0.003 NNT= 56 Simva 22.2% 1704 events EZ/Simva 20.4% 1544 events 7-year event rates
8 50 Reduction in Rate of Major Vascular Events (%) IMPROVE-IT 0 a b c d e f g h i j k l m n Reduction in LDL Cholesterol (mmol/liter)
9 Conclusions IMPROVE-IT: First trial demonstrating incremental clinical benefit when adding a non-statin agent (ezetimibe) to statin therapy: YES: Non-statin lowering LDL-C with ezetimibe reduces cardiovascular events YES: Even Lower is Even Better (achieved mean LDL-C 53 vs. 70 mg/dl at 1 year) YES: Confirms ezetimibe safety profile Reaffirms the LDL hypothesis, that reducing LDL-C prevents cardiovascular events Results could be considered for future guidelines
10 PCSK9 Inhibitors are here Recent FDA and EMEA approval of evolocumab and alirocumab for the treatment of high risk patients who have not achieved adequate LDL-C lowering on maximum tolerated therapy
11 Serum In the Presence LDL-Cholesterol of PCSK9, Binds the to LDL-R LDL-Receptors. Is Degraded Following and Does Not Cycle Back to Cell Internalization, LDLSurface is Degraded and the Receptor Recycled Discovered in Canada Plasma LDL PCSK9 LDL LDL-R LDL-R Endocytosis Hepatocyte Endocytosis LDL-R Recycling Endosome PCSK9 Self-procession Endosome Golgi Apparatus LDL Degradation LDL, LDL-R and PCSK9 Degradation Nucleus Qian YW, et al. J Lipid Res. 2007;48: ; Horton JD, et al. J Lipid Res. 2009;50(suppl):S172-S177. Endoplasmic Reticulum (ER) 2013 Amgen Canada Inc. All rights reserved.
12 Monoclonal Blocking PCSK9 Antibody Activity binds Inhibits to PCSK9 and inhibits Intracellular Binding to the Degradation LDL-Receptor of LDL-R PCSK9 MAb Plasma LDL LDL-R LDL-R Recycling Endocytosis Endosome Hepatocyte PCSK9 Self-procession Lyosome Golgi Apparatus LDL Degradation Nucleus Endoplasmic Reticulum (ER) 2013 Amgen Canada Inc. All rights reserved. Qian YW, et al. J Lipid Res. 2007;48: ; Horton JD, et al. J Lipid Res. 2009;50(suppl):S172-S177.
13 Loss-of-function Mutations in PCSK9 Are Associated with Lower Serum LDL-C and Lower Incidence of CHD 30 No Mutation (N=3,278) 50 th Percentile Frequency (%) 10 8 PCSK9 0 loss-of-function mutations found in 1% to 4% of population Associated with Loss of function mutation PCSK9 142X or PCSK9 679X (N=85) % reduction in mean LDL-C 88% reduction in lifetime risk of CHD* Coronary Heart Disease (%) 4 0 No Yes PCSK9 142X or PCSK9 679X Plasma LDL-C in Black Subjects (mmol/l) *(P = for the reduction; hazard ratio, 0.11; 95% CI, 0.02 to 0.81; P = 0.03) Cohen JC, et al. N Engl J Med. 2006;354:
14 PROFICIO Program Evaluates Reduction in LDL-C, Atherosclerosis, and CV Risk with Evolocumab Combo-therapy with statin Phase 2 Phase 3 LAPLACE (N = 629) LAPLACE-2 (N = 1,896) Mono-therapy MENDEL (N = 406) MENDEL-2 (N = 614) Statin-intolerant GAUSS (N = 157) GAUSS2 (N = 329) GAUSS3 (N = 100) HeFH with LDLR mutations HoFH with mutations in both LDLR alleles Long-term safety and efficacy Open-label extension Plaque imaging study Secondary prevention RUTHERFORD (N = 167) TESLA (N < 67) OSLER (N = 1,324) RUTHERFORD-2 (N = 307) TESLA/TAUSSIG (N < 250) DESCARTES (N = 901) OSLER-2 (N > 3,800) GLAGOV (N = 950) FOURIER (N = 22,500) Clinicaltrials.gov; Koren MJ, et al. Lancet. 2012;380: ; Guigliano RP, et al. Lancet. 2012;380: ; Sullivan D, et al. JAMA. 2012;308: ; Raal FJ, et al. Circulation. 2012;26:
15 Co-primary Endpoint: Consistent, Clinically Equivalent LDL-C Reduction Mean Percent Change from Baseline in LDL-C at Week 10/ Combination Therapy ( 115) Monotherapy ( 114) Q2W QM -70 Q2W QM HeFH ( 117) Statin-intolerant ( 116) Q2W QM -70 Q2W QM Placebo Week 10 and 12 Evo Week 10 and 12 Ezetimibe Week 10 and 12 Note: p<0.001 for all comparison versus placebo or ezetimibe
16 Alirocumab: ODYSSEY Phase II/III Program Overview PII Primary/secondary Prevention N = 77; 12 weeks Primary Hypercholesterolemia N = 92; 8 weeks HeFH population Add-on to max tolerated statin (+/- other LMT) HC in high CV risk population HC in high CV risk population (+/- other LMT)* Additional populations ODYSSEY MONO Patient on no background LMT N = 100; 6 months PIII ODYSSEY FH I N = 471; 18 months ODYSSEY FH II N = 250; 18 months ODYSSEY HIGH FH N = 105; 18 months ODYSSEY LONG TERM N = 2,100; 18 months ODYSSEY COMBO I N = 306; 12 months ODYSSEY COMBO II N = 660; 24 months ODYSSEY CHOICE I N = 700; 12 months ODYSSEY ALTERNATIVE Patients with defined statin intolerance N = 660; 24 months ODYSSEY CHOICE II Patients with hypercholesterolemia on non-statin LMT or diet N = 200; 6 months ODYSSEY OPTIONS I Patients not at goal with moderate dose atorvastatin N = 350; 6 months LMT= lipid modifying therapy * For the ODYSSEYCOMBO II other LMT not allowed at entry Clinicaltrials.gov ODYSSEY OUTCOMES N = 18,000 ODYSSEY OPTIONS II Patients not at goal with moderate dose rosuvastatin N = 300; 6 months
17 Alirocumab (PCSK9i mab): Phase III LDL-C Lowering Summary % change from baseline in reflexive LDL-C Monotherapy* Q2W n= % EZE n= % 26.9% had dose increase at W12 FH I FH II (HeFH, Combo with Statin) 9.1% 2.8% N=163 N= % 48.7% 43.4% had dose increase at W12 COMBO II* (Combo with Statin) Alirocumab 75 mg with potential to 150 mg Q2W SC, except for LONG TERM:Alirocumab 150 mg Q2W SC *Ezetimibe comparator N=81 N= % had dose increase at W12 N= % 18.4% had dose increase at W12 N= % 38.6% had dose increase at W12 LONG TERM (HeFH or high-risk, Combo with Statin) 0.8% N=780 Placebo Alirocumab Ezetimibe 61.0% Kastelein JJP, et al. Presented at ESC Sept 2014 (FH I & FH II); Roth EM, et al. Int J Cardiol Sep;176(1):55-61 (MONOTHERAPY); Cannon CP, et al. Presented at ESC Sept 2014 (COMBO II); Robinson JG, et al. Presented at ESC Sept 2014 (LONG TERM).
18 Robinson JG et al. N Engl J Med DOI: /NEJMoa
19 ODYSSEY LONG TERM Study Design HeFH or High CV-risk patients On max-tolerated statin ± other lipid-lowering therapy LDL-C 1.81 mmol/l [70 mg/dl] Assessments R W0 n=1553 n=788 W4 W8 W12 Double-blind treatment (18 months) Alirocumab 150 mg Q2W SC (single 1-mL injection using prefilled syringe for self-administration) Placebo Q2W SC W16 W24 W36 W52 W64 W78 Follow-up (8 weeks) Primary efficacy endpoint Pre-specified analysis Efficacy: All Patients uo to W52 Safety: Baseline-W78 All patients 73% completed the study (both treatment arms) 99.9% were included in the safety analysis (both treatment arms) ClinicalTrials.gov identifier: NCT
20 LDL-C Over Time
21 Mean Kaplan-Meier treatment Estimates for Time to First Adjudicated Major CV Event duration: 80 weeks No. at Risk Placebo Alirocumab 21 Post-hoc Adjudicated Cardiovascular TEAEs Safety Analysis (at least 52 weeks for all patients in ongoing study) Safety Analysis (at least 52 weeks for all patients continuing treatment, including 607 patients who completed W78 visit) Cumulative probability of event Placebo + max-tolerated statin ± other LLT Alirocumab + max-tolerated statin ± other LLT Cox Cox model model analysis: analysis: HR=0.46 HR=0.52 (95% (95% CI: CI: to to 0.82) 0.90) Nominal Nominal p-value p-value = < Mean treatment Duration: duration: weeks Primary endpoint for the ODYSSEY OUTCOMES trial: CHD death, Non-fatal MI, Fatal and non-fatal ischemic stroke, Unstable angina requiring hospitalisation. LLT, lipid-lowering therapy Robinson JG et al. N Engl J Med DOI: /NEJMoa Weeks
22
23 Cardiovascular Outcomes 3 Composite Endpoint: Death, MI, UA hosp, coronary revasc, stroke, TIA, or CHF hosp Cumulative Incidence (%) 2 1 HR % CI P=0.003 Standard of care alone (N=1489) 2.18% 0.95% 0 Evolocumab plus standard of care (N=2976) Days since Randomization
24 Ongoing Outcome Trials with PCSK9 Inhibitors Study FOURIER ODYSSEY OUTCOMES SPIRE-1 Treatment Evolocumab 420 mg Q4W or 140 mg Q2W with atorvastatin Background: EZE allowed Alirocumab 75 mg Q2W (up titrated to 150 mg Q2W if LDL > 1.3 mmol/l; down titrated if LDL < 0.65mmol/L) Background: optimized lipid lowering therapy Bococizumab 150 mg Q2W Background: Lipid lowering therapy Population Recent MI or stroke (< last 6 months) OR Recent history ( 5 years) MI or stroke and either a history of T2DM or, if not diabetic, additional risks factors Patients hospitalized for ACS (<12 months before randomization) Patients at high risk of a CV event # patients 22,500 18,000 12,000 LDL-C for eligibility LDL-C 1.8 mmol/l (or non- NonHDL-C 2.6 mmol/l) after 4 week stabilization with atorva ± EZE 1.8 mol/l LDL C 1.8 and < 2.6 mmol/l Est. study completion February 2018 January 2018 August 2017 EZE = ezetimibe Source: clinicaltrials.gov
25 Changes in Lipid Guidelines and Cholesterol Targets Have Typically Followed Shortly after Clinical Trials KEY TRIALS CANADIAN GUIDELINES HPS ASCOT PROVE-IT TIMI 22 CCS < 2.5 mmol/l and TC:HDL-C <4.0 TNT CTTC CCS < 2 mmol/l or 50% Reduction CTTC (14 trials) CCS < 2 mmol/l or 50% Reduction CTTC (27 trials) JUPITER CCS < 2 mmol/l or 50% Reduction US GUIDELINES EU GUIDELINES NCEP ATP III, AHA/ACC 2.6 mmol/l ESC 2 nd Task Force 2.6 mmol/l NCEP ATP III Revised AHA/ACC 2.6mmol/L 2.6mmol/L 1.8mmol/L 1.8mmol/L Optional Optional ESC 3 rd Task Force 2.6mmol/L (2.1 mmol/l if feasible) AHA/ACC 2.6mmol/L 1.8mmol/L Optional ESC 4 th Task Force 1.8mmol/L or 50% Reduction AHA/ACC Sources: clinicaltrials.gov; Canadian Cardiovascular Society (ccs.ca); National Cholesterol Education Program USA (nhlbi.nih.gov); European Society of Cardiology (escardio.org).
26 LDL-C Remains the Primary Target with Emerging Role for Non-HDL-C and ApoB as Alternate Targets Risk Level Initiate Therapy If Primary Target LDL-C Alternate Target High FRS 20% Consider treatment in all (Strong, High) 2 mmol/l or 50% decrease in LDL-C (Strong, High) ApoB 0.8 g/l Non HDL-C 2.6 mmol/ L (Strong, High) Intermediate FRS 10%-19% LDL-C 3.5 mmol/l (Strong, Moderate) For LDL-C < 3.5 consider if: Apo B 1.2 g/l or Non-HDL-C 4.3 mmol/l (Strong, Moderate) 2 mmol/l or 50% decrease in LDL-C (Strong, Moderate) ApoB 0.8 g/l Non HDL-C 2.6 mmol/l (Strong, Moderate) Low FRS < 10% LDL-C 5.0 mmol/l Familial hypercholesterolemia (Strong, Moderate) 50% decrease in LDL-C (Strong, Moderate) Strong, High: Strong Recommendation, High-quality Evidence Strong, Moderate: Strong Recommendation, Moderate-quality Evidence Anderson TJ, Grégoire J, et al Update of CCS Dyslipidemia Guidelines. Can J Cardiol. 2013;29:
27 Comparison of Guidelines: More Similar than Different CCS EAS/ESC AHA/ACC Risk Assessment Tool Modified Framingham Risk Score (FRS) Systematic COronary Risk Evaluation (SCORE) Pooled Cohort Atherosclerotic CV Disease (ASCVD) Risk Estimator Estimates 10-year risk of developing cardiovascular disease using: Age Gender Total cholesterol HDL-C Smoking Systolic blood pressure On medication for high BP Diabetes Estimates 10-year risk of first fatal atherosclerotic event using: Age Gender Total cholesterol HDL-C Smoking Systolic blood pressure Diabetes Predicts 10-year risk for a first atherosclerotic cardiovascular disease (ASCVD) event using: Age Gender Total cholesterol HDL-C Smoking Systolic blood pressure On medication for high BP Diabetes Race Other Risk Estimations Cardiovascular age Lifetime risk Total (fatal+non-fatal) Cardiovascular disease Lifetime risk CKD or High Risk Hypertension Treat with statins Treat with statins No specific recommendations Includes global CVD (coronary and cerebrovascular disease and CHF) Estimates hard CHD (coronary death or MI) Anderson TJ, Grégoire J, et al Update of CCS Dyslipidemia Guidelines. Can J Cardiol. 2013;29: ; Stone NJ, et al ACC/AHA Guideline. Circulation. 2014; 29(25 Suppl 2):S1-S45; Reiner Ž et al. ESC/EAS Guidelines for the management of dyslipidaemias. Atherosclerosis. 217S (2011);S1-S44, doi: /j.atherosclerosis
28
29 Stay Tuned New CCS Guidelines October 2015 CCC
New 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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: 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 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 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 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 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 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 informationReview of guidelines for management of dyslipidemia in diabetic patients
2012 international Conference on Diabetes and metabolism (ICDM) Review of guidelines for management of dyslipidemia in diabetic patients Nan Hee Kim, MD, PhD Department of Internal Medicine, Korea University
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 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 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 informationFernando-Cruz Foundation Symposium, Hospital Clinico San Carlos, Madrid 2015
Fernando-Cruz Foundation Symposium, Hospital Clinico San Carlos, Madrid 2015 Management of Hypercholesterolemia beyond Statins : ODYSSEY and OSLER Trials M. John Chapman BSc (Hons), Ph.D., D.Sc., FESC
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 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 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 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 informationObjectives. Hypercholesterolemia and Coronary Heart Disease. LDL Cholesterol. Hypercholesterolemia Is a Global Public Health Epidemic
12:3 1:45 pm Dyslipidemia in Primary Care: New Guideline Recommendations and Treatment Options SPEAKERS Carl E. Orringer, MD, FACC, FNLA James A. Underberg, MD, MS, FACPM, FACP, FASH, FNLA Presenter Disclosure
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 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 informationIMPROVE-IT : Are we back to the lower the better? Further LDL-Cholesterol lowering on top of statins: backgrounds and the results of the study
IMPROVE-IT : Are we back to the lower the better? Further LDL-Cholesterol lowering on top of statins: backgrounds and the results of the study Fundación Fernández-Cruz Clinico San Carlos, Madrid Spain,
More informationIMProved Reduction of Outcomes: Vytorin Efficacy International Trial
IMProved Reduction of Outcomes: Vytorin Efficacy International Trial A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet)
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 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 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 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 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 informationDyslipidemia in the light of Current Guidelines - Do we change our Practice?
Dyslipidemia in the light of Current Guidelines - Do we change our Practice? Dato Dr. David Chew Soon Ping Senior Consultant Cardiologist Institut Jantung Negara Atherosclerotic Cardiovascular Disease
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 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 informationThe JUPITER trial: What does it tell us? Alice Y.Y. Cheng, MD, FRCPC January 24, 2009
The JUPITER trial: What does it tell us? Alice Y.Y. Cheng, MD, FRCPC January 24, 2009 Learning Objectives 1. Understand the role of statin therapy in the primary and secondary prevention of stroke 2. Explain
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 informationGuidelines on Lowering LDL-C Levels
Scientific Insights Into LDL-C, PCSK9, and CV Risks High circulating LDL-C levels are associated with increased risk for ASCVD 1,2 Statin drugs interfere with cholesterol production, lowering serum LDL-C
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 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 informationDisclosure. No relevant financial relationships. Placebo-Controlled Statin Trials
PREVENTING CARDIOVASCULAR DISEASE IN WOMEN: Current Guidelines for Hypertension, Lipids and Aspirin Disclosure Robert B. Baron, MD MS Professor and Associate Dean UCSF School of Medicine No relevant financial
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 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 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 informationEvolocumab for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia
Evolocumab for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia Lead author: Nancy Kane Regional Drug & Therapeutics Centre (Newcastle) November 2015 2015 Summary Evolocumab (Repatha,
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 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 informationManagement of Dyslipidaemias: PCSK9 Inhibition. Alberico L. Catapano Professor President EAS University of Milano Italy
Management of Dyslipidaemias: PCSK9 Inhibition Alberico L. Catapano Professor President EAS University of Milano Italy Conflict of interest Grants, consulting fees and/or honoraria and delivering lectures
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 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 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 informationLong-term safety, tolerability and efficacy of alirocumab in high cardiovascular risk patients: ODYSSEY LONG TERM
Long-term safety, tolerability and efficacy of alirocumab in high cardiovascular risk patients: ODYSSEY LONG TERM Efficacy by subgroup, and safety when LDL-C
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 informationIMProved Reduction of Outcomes: Vytorin Efficacy International Trial
Trial Leadership IMProved Reduction of Outcomes: Vytorin Efficacy International Trial A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/statin
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 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 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 informationCost-effectiveness of evolocumab (Repatha ) for primary hypercholesterolemia and mixed dyslipidemia.
Cost-effectiveness of evolocumab (Repatha ) for primary hypercholesterolemia and mixed dyslipidemia. The NCPE has issued a recommendation regarding the cost-effectiveness of evolocumab (Repatha ) Following
More informationPCSK9 Inhibitors and Canadian Cardiovascular Lipid Guidelines
PCSK9 Inhibitors and Canadian Cardiovascular Lipid Guidelines Robert C. Welsh, MD, FRCPC Professor of Medicine, University of Alberta Zone Clinical Department Head, Cardiac Sciences Inspiring Innovation
More informationTreating Hyperlipidemias in Adults. Lisa R. Tannock MD Division of Endocrinology and Molecular Medicine, University of Kentucky Lexington KY VAMC
Treating Hyperlipidemias in Adults Lisa R. Tannock MD Division of Endocrinology and Molecular Medicine, University of Kentucky Lexington KY VAMC Disclosures Conflicts: None Talk will address off-label
More informationHow would you manage Ms. Gold
How would you manage Ms. Gold 32 yo Asian woman with dyslipidemia Current medications: Simvastatin 20mg QD Most recent lipid profile: TC = 246, TG = 100, LDL = 176, HDL = 50 What about Mr. Williams? 56
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 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 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 informationLDL Cholesterol Lowering with Evolocumab and Outcomes in Patients with Peripheral Artery Disease: Insights from the FOURIER Trial
LDL Cholesterol Lowering with Evolocumab and Outcomes in Patients with Peripheral Artery Disease: Insights from the FOURIER Trial Marc P. Bonaca, Patrice Nault, Robert P. Giugliano, Anthony C. Keech, Armando
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 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 informationReview current guideline recommendations for lipid-lowering therapy
Breakout Session #3 New Paradigms in the Management of Dyslipidemia Review current guideline recommendations for lipid-lowering therapy Dr Meral KAYIKCIOGLU Ege University Medical School, Cardiology Dept,
More informationLipoprotein(a), PCSK9 Inhibition and Cardiovascular Risk: Insights from the FOURIER Trial
Lipoprotein(a), PCSK9 Inhibition and Cardiovascular Risk: Insights from the FOURIER Trial Michelle L. O Donoghue, Robert P. Giugliano, Anthony C. Keech, Estella Kanevsky, KyungAh Im, Peter S. Sever, Terje
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 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 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 informationLipid Control Today: Management within the Context of other Cardiovascular Risk Factors
Best Practices Lipid Control Today: Management within the Context of other Cardiovascular Risk Factors James A. Underberg, MD, MS, FACPM, FACP, FASH, FNLA, FASPC Lipidology & Cardiovascular Disease Prevention
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 informationSystematic review of published Phase 3 data on anti-pcsk9 monoclonal antibodies in patients with hypercholesterolaemia
British Journal of Clinical Pharmacology SYSTEMATIC REVIEW Br J Clin Pharmacol (2016) 82 1412 1443 1412 Systematic review of published Phase 3 data on anti-pcsk9 monoclonal antibodies in patients with
More informationYoung high risk patients the role of statins Dr. Mohamed Jeilan
Young high risk patients the role of statins Dr. Mohamed Jeilan KCS Congress: Impact through collaboration CONTACT: Tel. +254 735 833 803 Email: kcardiacs@gmail.com Web: www.kenyacardiacs.org Disclosures
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 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 informationFarmaci innovativi in ambito cardiovascolare: considerazioni di Farmacologia. Prof. Alberto Corsini University of Milan, Italy
Farmaci innovativi in ambito cardiovascolare: considerazioni di Farmacologia Prof. Alberto Corsini University of Milan, Italy Outline of the presentation State of the art on statin therapy Explore unmet
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 information