Managing Dyslipidemia in 2018 - ccpn.ca · Dyslipidemia Guidelines Speaker Disclosures • I have...
Transcript of Managing Dyslipidemia in 2018 - ccpn.ca · Dyslipidemia Guidelines Speaker Disclosures • I have...
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Dyslipidemia Guidelineswww.ccs.ca
Managing Dyslipidemia in 2018Glen J. Pearson, BSc, BScPhm, PharmD, FCSHP, FCCS
Professor of Medicine (Cardiology)Co-Director, Cardiac Transplant Clinic;
Associate Chair, Health Research Ethics Boards;Chair, Trainee Research Access Committee (TRAC);
Faculty of Medicine and Dentistry; University of Alberta; Mazankowski Alberta Heart Institute
17th Annual Cardiovascular Fall SymposiumEdmonton ABSeptember 29th, 2018
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Dyslipidemia Guidelineswww.ccs.ca
Speaker Disclosures
• I have the following potential conflicts to disclose.
– no financial or industry disclosures– member of CCS Dyslipidemia Guidelines primary panel since 2007– Vice-Chair of the 2016 CCS Dyslipidemia Guidelines primary panel
and current chair of the 2018 panel– a primary member of the Canadian Working Group for the Diagnosis,
Prevention, and Management of Statin Adverse Effects and Intolerance – 2013 and 2016.
– a primary panel member of the 2018 CCS FH Guidelines panel and secondary panel member of the CCS 2014 Position Statement on Familial Hypercholesterolemia
– Clinician member and PI of the new Familial Hypercholesterolemia Canada Registry practitioner and research initiative.
– I believe in the LDL hypothesis
Disclosures
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Dyslipidemia Guidelineswww.ccs.ca
Learning Objectives
1. To review recent evidence for the use of PCSK-9 inhibitors in treating dyslipidemia and improving CV outcomes.
FOURIER (Evolocumab) ODYSSEY Outcomes (Alirocumab)
2. To briefly highlight the potential benefit of very low-LDL cholesterol levels in high risk patients.
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Dyslipidemia Guidelineswww.ccs.ca
Category Consider Initiating pharmacotherapy if: Target NNT
Primary Prevention High(FRS ≥20%)
LDL-C < 2.0 mmol/L or > 50% ↓
Or
Apo B < 0.8 g/L
Or
non-HDL-C < 2.6 mmol/L
35
Intermediate(FRS 10-19%)
LDL-C ≥3.5 mmol/L or Non-HDL-C ≥4.3 mmol/Lor Apo B ≥1.2 g/Lor Men ≥50 & women ≥60 yrs and ≥1 CV risk factor
40
Statin Indicated Conditions***
Clinical atherosclerosis(CAD, CVD, PAD)
20
Abdominal aortic aneurysm
Diabetes mellitus: ≥40 yrs, or >15 yrs duration & age ≥30 yrs (DM 1), or microvascular disease
CKD (age ≥ 50 yrs): eGFR< 60 mL/min/1.73 m2, or ACR > 3 mg/mmol
LDL-C ≥5.0 mmol/L >50% ↓ in LDL-C
Pharmacological Treatment Indications & Targets
Anderson TJ, Gregoire J, Pearson GJ et al., Can J Cardiol 2016 (In-Press). DOI: 10.1016/j.cjca.2016.07.510
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Dyslipidemia Guidelineswww.ccs.ca
Speaker Disclosures
Proprotein convertase subtilisin/kexintype 9 (PCSK9) Inhibitors
The Current Evolution (Revolution?)
in Lipid Lowering Therapy
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PCSK-9 Inhibitors
Nat Rev Cardiol 2014;11:563‐75
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PCSK-9 Inhibitors
Nat Rev Cardiol 2014;11:563‐75
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Dyslipidemia Guidelineswww.ccs.ca
Ongoing CV Outcomes Trials:PCSK-9 Inhibitors
• ACS: Acute coronary syndrome; F: Fatal;
• NF: Nonfatal; MI: Myocardial infarction;
• UA: Unstable angina
Adapted from: www.Clinicaltrials.gov; date last accessed: 25th August 2015
March 2017
March 2018
2017-2018Manufacturer D/C’d Global Development of product – Nov 1/16
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
Further Details
This article was published on March 17, 2017, at NEJM.org.DOI: 10.1056/NEJMoa1615664.
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
Trial Design
Evolocumab SC 140 mg Q2W or 420 mg QM
Placebo SCQ2W or QM
LDL-C ≥1.8 mmol/L ornon-HDL-C ≥2.6 mmol/L
Follow-up Q 12 weeks
Screening, Lipid Stabilization, and Placebo Run-in
High or moderate intensity statin therapy (± ezetimibe)
27,564 high-risk, stable patients with established CV disease (prior MI, prior stroke, or symptomatic PAD)
RANDOMIZEDDOUBLE BLIND
Sabatine MS et al. Am Heart J 2016;173:94-101
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
Endpoints• Efficacy
– Primary: CV death, MI, stroke, hosp. for UA, or coronary revasc– Key secondary: CV death, MI or stroke
• Safety– AEs/SAEs– Events of interest incl. muscle-related, new-onset diabetes,
neurocognitive – Development of anti-evolocumab Ab (binding and neutralizing)
• TIMI Clinical Events Committee (CEC)– Adjudicated all efficacy endpoints & new-onset diabetes– Members unaware of treatment assignment & lipid levels
Sabatine MS et al. Am Heart J 2016;173:94-101
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
Randomized 27,564 patients
Evolocumab(N=13,784)
Placebo(N=13,780)
Premature perm.drug discontinuation 5.6%/yr 5.8%/yr
Withdrew consent 0.29%/yr 0.35%/yr
Lost to follow-up 5 patients 13 patients
Follow-up median 26 months (IQR 22-30)
Ascertainment for primary endpoint was complete for99.5% of potential patient-years of follow up
Follow-up
2907 patients experienced primary endpoint1829 experienced key secondary endpoint
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
Baseline Characteristics
Characteristic ValueAge, years, mean (SD) 63 (9)Male sex (%) 75Type of cardiovascular disease (%)
Myocardial infarction 81Stroke (non-hemorrhagic) 19Symptomatic PAD 13
Cardiovascular risk factor (%)
Hypertension 80Diabetes mellitus 37Current cigarette use 28
Pooled data; no differences between treatment arms
Median time from most recent event ~3 yrs
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
Lipid Lowering Therapy& Lipid Levels at Baseline
Characteristic ValueStatin use (%)*
High-intensity 69Moderate-intensity 30
Ezetimibe use (%) 5Median lipid measures (IQR) – mmol/L
LDL-C 2.4 (2.1-2.8)Total cholesterol 4.35 (3.9-4.9)HDL-C 1.14 (0.96-1.37)Triglycerides 1.5 (1.13-2.06)
Pooled data; no differences between treatment arms
*Per protocol, patients were to be on atorva ≥20 mg/d or equivalent.1% were on low intensity or intensity data were missing.Statin intensity defined per ACC/AHA 2013 Cholesterol Guidelines.
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2.6
2.3
2.1
1.8
1.6
1.3
1..05
0.8
0.5
0.25
1.45 mmol/L (95% CI 142-147
median 0.78 mmol/L, IQR 0.5-1.2 mmol/L
(mm
ol/L
)
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
Summary for Evolocumab
• LDL-C by 59%– Consistent throughout duration of trial– Median achieved LDL-C of 0.78 mmol/L, IQR 0.5-1.2 mmol/L
• CV outcomes in patients already on statin therapy– 15% broad primary endpoint; 20% CV death, MI, or stroke– Consistent benefit, incl. in those on high-intensity statin, low LDL-C– 25% reduction in CV death, MI, or stroke after 1st year– Long-term benefits consistent w/ statins per mmol/L LDL-C
• Safe and well-tolerated – Similar rates of AEs, includiing DM & neurocognitive events w/
Evolocumab & placebo– rates of evolocumab D/C low and no greater than placebo– No neutralizing antibodies developed
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
LDL ≥ 1.8 mmol/LNon-HDL-C ≥ 2.6 mmol/LApo-B ≥ 0.80 g/L
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
1.81.30.4 0.6
(mmol/L)
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
2.3 (1.9-2.7) 2.3 (1.9-2.7)
3.0 (2.6-3.5) 3.0 (2.6-3.5)
1.1 (0.95-1.3) 1.1 (0.9-1.3)
1.45 (1.05-2.05) 1.45 (1.07-2.07)
(1.8 mmol/L)
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2.42.67
0.98 1.09
1.37
2.72
2.32
1.94
1.55
1.16
0.76
0.34
Mean LD
L‐C mmol/L
∆ 1.44 mmol/L
∆ 1.40 mmol/L
∆ 1.24 mmol/L
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
LDL (mmol/L)<2.12.1 - <2.6≥2.6
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
<2.1 mmol/L 2.1 - <2.6 mmol/L ≥2.6 mmol/L
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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An Academic Research Organization of Brigham and Women’s Hospital and Harvard Medical School
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Dyslipidemia Guidelineswww.ccs.ca
Data on LDL-C and Risk of CVD
Ference BA, et al. Eur Heart J 2017. (doi: 10.1093/eurheartj/ehx144.)
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Dyslipidemia Guidelineswww.ccs.ca
Meta-Analysis: In-Trial Achieved LDL
Boekholdt et al. J Am Coll Cardiol. 2014;64(5):485-495.
Meta-analysis of 8 statin trials (n=38,153): • >40% did not reach
LDL-C target (<1.8 mmol/L) on high dose statin
• Patients achieving LDL-C <1.3 mmol/L are at lower CVD risk than those achieving an LDL-C of 1.9 to <2.6 mmol/L
1.00
0.75
0.50
0.25 10
20
30
40
0 1.3 2.6 3.9 5.2 6.5
HR
for M
ajor
CV
Eve
nts
( )
Per
cent
of P
atie
nts
( )
Achieved On-statin LDL Levels
On-Statin LDL-C Levels and Risk for Major Cardiovascular Events
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Dyslipidemia Guidelineswww.ccs.ca
LDL
–c L
evel
s
LDL Target: <2.5 mmol/L (Canadian Guidelines 2000 & 2003)Evidence: CARE, 4S, AF/TexCAPS, WOSCOPS, etc.
LDL Target: <2.0 mmol/L (Cdn Guidelines 2006, 2009, 2012 & 2016)Evidence: TNT, IDEAL, and PROVE-IT
LDL Target: <1.8 mmol/L (ESC/EAS Guidelines 2016)Evidence: IMPROVE-IT
LDL Target: <1.0 (Future Guidelines??)Evidence: FOURIER (median on-treatment LDL = 0.78 mmol/L at 26 months)ODYSSEY (mean on-treatment LDL = 1.37 mmol/L at 48 months)
Evolution of LDL Targets:How Much Lower is Better?
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Dyslipidemia Guidelineswww.ccs.ca
Questions?