PCSK9 Inhibitors Post-CVOTs

Background

FOURIER Trial Design

FOURIER: Lower CV Event Rates With Lower LDL-C Levels, FOURIER: Lower CV Event Rates With Lower LDL-C Levels,* Even Down to 20 mg/dL

The SPIRE-2 Cardiovascular Outcomes Trial: Baseline LDL-C ≥ 100 mg/dL Primary Prespecified Endpoint*

Topline Results

Main Inclusion Criteria

Key Exclusion Criteria

Primary Efficacy Outcome

Major Secondary Efficacy Endpoints

Treatment Assignment

A Target Range for LDL-C

Statistical Considerations

ODYSSEY OUTCOMES 18,924 Patients Randomized at 1315 Sites in 57 Countries, November 2, 2012-November 11, 2017

Patient Disposition

Baseline Demographics

Baseline Index Events

Baseline Lipid Characteristics

Baseline Lipid-Lowering Therapy

Guideline-Recommended Post-ACS Medications

LDL-C ITT and On-Treatment Analyses

LDL-C On-Treatment Analysis

Primary Efficacy Endpoint MACE

Primary Efficacy and Components

Main Secondary Efficacy Endpoints Hierarchical Testing

All-Cause Death

Primary Efficacy in Main Prespecified Subgroups

Efficacy Subgroup With Baseline LDL-C  100 mg/dL (Median Baseline LDL-C 118 mg/dL)

Safety (1)

Safety (2)

Conclusions

Clinical Perspective

ODYSSEY OUTCOMES vs FOURIER Patient Histories

ODYSSEY OUTCOMES vs FOURIER LLTs and Lipids

ODYSSEY OUTCOMES vs FOURIER Primary Endpoints

PCSK9 CVOTs Key Scientific Points

2013 ACC/AHA Statin Therapy Recommendations

Pyramid of Risk

Barriers in Access to CVD Therapies: PCSK9 Inhibitors

Alirocumab and Evolocumab US Labelling and Indications

Alirocumab and Evolocumab European Labeling and Indications

Access to PCSK9 Inhibitors

FH Foundation's Findings: Access to Nonstatin LLTs in Patients at High Risk of ASCVD or With ASCVD

Access Barrier Through Prior Authorization and High Copays

CLC Consensus Paper: Open Access

Pragmatic Tools to Gain PCSK9 mAb Access for Appropriate Patients

Interprofessional Care Team

Abbreviations

Abbreviations (cont)