• ~90% of patients in ODYSSEY OUTCOMES were on high-intensity statins1

    ~90% of patients in ODYSSEY OUTCOMES were on high-intensity statins
    Study design: ODYSSEY OUTCOMES was a randomized, double-blind, placebo-controlled phase 3 study. Patients with a recent MI or unstable angina, and on high-intensity statin (40 or 80 mg atorvastatin or 20 or 40 mg rosuvastatin, or maximally tolerated dose of one of these agents) +/- other lipid-lowering therapy but not at predefined target LDL-C were enrolled.1

    MACE

    In patients with a prior CV event, Praluent® demonstrated a significant reduction in risk of MACE for the overall trial population (RRR of 15% vs placebo, HR 0.85 [95% CI 0.78-0.93] p=0.0003).2

    A greater absolute benefit was observed in patients with baseline ≥2.6 mmol/L LDL-C (non-prespecified analysis).2

    See Kaplan-Meier curves for MACE

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    Overall efficacy in main CV outcomes

    Praluent® provided consistent results across CV outcomes1

    Among the main secondary endpoints, the risks of any CHD event (including CHD death, nonfatal MI, UA requiring hospitalisation, and an ischaemia-driven coronary revascularisation procedure), major CHD event (including death from CHD and nonfatal MI), CV event (including nonfatal MI and nonfatal ischaemic stroke), and a composite of death from any cause, nonfatal MI or nonfatal ischemic stroke were significantly lower among patients treated with Praluent® than those who received placebo.1

    View table and forest plot of CV outcome results

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    All-cause mortality

    Praluent® was associated with a reduction of all-cause mortality (nominal significance by hierarchical testing), with a 15% RRR across the overall trial population (HR 0.85; 95% CI 0.73–0.98)2,3.

    A greater benefit (29% RRR) was observed in patients with baseline ≥100 mg/dL LDL-C (HR 0.71; 95% CI 0.56–0.90).2,3**

    **Post-hoc analysis.

    View forest plot for all-cause mortality

    View results

    ODYSSEY OUTCOMES

    TRIAL DESIGN

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    ODYSSEY OUTCOMES

    PRALUENT® SAFETY PROFILE

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    ACS=acute coronary syndrome; ARR=absolute risk reduction; CHD=coronary heart disease; CI=confidence interval; CV=cardiovascular; HCL-C=high-density lipoprotein cholesterol; HR=hazard ratio; LDL-C=low-density lipoprotein cholesterol; MACE=major adverse cardiac events (primary composite endpoint of CHD death, nonfatal myocardial infarction, fatal and nonfatal ischaemic stroke, or unstable angina requiring hospitalization); MI=myocardial infarction; NNT=number needed to treat; PCSK9i=proprotein convertase subtilisin/kexin type 9 inhibitor; RRR=relative risk reduction.

    1. Schwartz G, et al. N Engl J Med 2018;379:2097–2107.
    2. Praluent® (alirocumab) European Summary of Product Characteristics. March 2019.
    3. Schwartz G, et al. N Engl J Med 2018;379:2097–2107. Supplementary Appendix.