• PCSK9 and Praluent®

    SPECIFIC CHARACTERISTICS OF PRALUENT®

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    Praluent® patients

    POST-ACS PATIENTS ARE AT HIGH RISK FOR RECURRENT CV EVENTS2

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    ODYSSEY OUTCOMES

    PRALUENT® RESULTS FROM THE ODYSSEY OUTCOMES TRIAL

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    PRALUENT® APPROVED TO REDUCE CV RISK

    Praluent (alirocumab) is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:

    - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
    - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated1


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    In patients with a prior CV event who need further LDL-C lowering,

    PRALUENT® SIGNIFICANTLY REDUCED THE RISK OF MACE IN PATIENTS ALREADY ON HIGH-INTENSITY STATINS2

    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.2

    *A CV event defined as a part of a composite in ODYSSEY OUTCOMES clinical trial is coronary heart disease death, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospitalisation2

    ACS=acute coronary syndrome; CHD=coronary heart disease; CI=confidence interval; CV=cardiovascular; 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; PCSK9i=proprotein convertase subtilisin/kexin type 9 inhibitor; RRR=relative risk reduction.

    1. Praluent® (alirocumab) European Summary of Product Characteristics. March 2019.
    2. Schwartz G, et al. N Engl J Med 2018;379(22):2097–2107.
    3. Schwartz G, et al. N Engl J Med 2018;379(22):2097–2107. Supplementary Appendix.