all time low: safety and efficacy of treating to very low ...€¦ · cv: cardiovascular cva:...

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All Time Low:

Safety and Efficacy of Treating to Very Low LDL

with Non-statin Adjuvants

September 6th, 2019

Aamer Attaar, PharmD

PGY-2 Internal Medicine Pharmacy Resident

Ascension Seton

Aamer.Attaar@ascension.org

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Table of Contents

Presentation Slides…………………………………………………………..pages 3 to 13

Appendix A: Abbreviations………………………………………………………..page 14

Appendix B: Guideline Definitions……………………………………………..page 15

Appendix C: ODYSSEY LONG TERM Adverse Events Table………….page 16

Appendix D: OSLER Adverse Events Table………………………………….page 17

Appendix E: REDUCE-IT Efficacy Endpoints………………………………..page 18

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Appendix A: Abbreviations

ACC: American College of Cardiology

ACS: Acute coronary syndrome

AF: Atrial Fibrillation

AHA: American Heart Association

ASA: Aspirin

ASCVD: Atherosclerotic cardiovascular disease

CAD: Coronary artery disease

CETP: Cholesteryl ester transfer protein

CKD: Chronic kidney disease

CV: Cardiovascular

CVA: Cerebrovascular accident

DAPT: Dual antiplatelet therapy

DM: Diabetes mellitus

HDL: High-density lipoprotein

HTN: Hypertension

LDL: Low-density lipoprotein

MACE: Major adverse cardiovascular events

MDD: Major depressive disorder

MI: Myocardial infarction

NSTEMI: Non-ST elevation myocardial infarction

PCI: Percutaneous coronary intervention

PCSK9: Protein convertase subtilisin/kexin type 9

TC: Total cholesterol

TG: Triglycerides

TIA: Transient ischemic attack

UA: Unstable angina

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Appendix B: Guideline Definitions

Metabolic syndrome – 3 out of 5 of the following characteristics:

• Increased waist circumference (> 40 inches in men; > 35 inches in women)

• Elevated triglycerides (> 150 mg/dL)

• Elevated blood pressure (> 130/> 85 mmHg)

• Elevated glucose (fasting > 110 mg/dL)

• Low HDL (< 40 mg/dL in men; < 50 mg/dL in women)

High-risk (1 major ASCVD event and other high-risk conditions or a history of multiple major

ASCVD events):

• Major ASCVD event:

o Recent ACS (within past 12 months)

o History of MI or ischemic stroke

o Symptomatic peripheral arterial disease

• High-risk conditions:

o Age > 65

o Heterozygous familial hypercholesterolemia

o History of prior CABG or PCI outside of a major ASCVD event

o Diabetes mellitus

o Hypertension

o CKD (eGFR 15-59 mL/min/1.73m2)

o Current smoker

o Persistently elevated LDL > 100 mg/dL despite maximally tolerated statin and

ezetimibe therapy

o History of congestive heart failure

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Appendix C: Robinson JG, et al. N Engl J Med. 2015;372:1489-99.

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Appendix D: Sabatine MS, et al. N Engl J Med. 2015;372:1500-9.

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Appendix E: Bhatt DL, et al. N Engl J Med. 2019;380:11-22.