• Praluent® safety and tolerability profile

    Patients treated with Praluent® experienced a similar frequency of adverse events to those on placebo, but with more local injection site reactions* (p<0.001) — although these were usually mild and self-limited.2

    No difference in safety profile was observed between the two doses of Praluent® (75 mg and 150 mg) used in the phase 3 program.1†

    Adverse events2

    Adverse events table
     

    Adapted from Schwartz et al. 2018.
    *p<0.001
    New-onset diabetes was defined according to the presence of one or more of the following, with confirmation of the diagnosis by blinded external review by experts in the field of diabetes:
    an adverse event report, a new prescription for diabetes medication, a glycated hemoglobin level of at least 6.5% on two occasions (and a baseline level of <6.5%), or a fasting serum glucose level of at least 126 mg/dL on two occasions (and a baseline level of <126 mg/dL).2
    DM=diabetes mellitus

     

    Additional safety information

    Contraindications1

    Hypersensitivity to the active substance or to any of the following excipients: Histidine, Sucrose, Polysorbate 20, water for injection.

    Summary of safety profile1

    In ten phase 3 controlled trials, involving patients with primary hypercholesterolemia and mixed dyslipidemia, the most common adverse reactions were local injection site reactions, upper respiratory tract signs and symptoms, and pruritus. Most common adverse reactions leading to treatment discontinuation in patients treated with Praluent® were local injection site reactions.

    Immunogenicity/anti-drug-antibodies (ADA)1

    Anti-drug antibody responses, including NAb, were low titre and did not appear to have a clinically meaningful impact on the efficacy or safety of Praluent®, except for a higher rate of injection site reactions in patients with treatment-emergent ADA compared to patients who were ADA negative (7.5% vs 3.6%). The long-term consequences of continuing Praluent® treatment in the presence of ADA are unknown.

    In a pool of 10 placebo-controlled and active-controlled trials of patients treated with Praluent® 75 mg and/or 150 mg Q2W as well as in a separate clinical study of patients treated with Praluent® 75 mg Q2W or 300 mg Q4W (including some patients with dose adjustment to 150 mg Q2W), the incidence of detecting ADA and NAb was similar to the results from the ODYSSEY OUTCOMES trial.

    LDL-C values <25 mg/dL (<0.65 mmol/L)

    Although adverse consequences of very low LDL-C were not identified in alirocumab trials, the long-term effects of very low levels of LDL-C are unknown.

    ODYSSEY OUTCOMES

    TRIAL DESIGN

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    ODYSSEY OUTCOMES

    PRALUENT® EFFICACY IN THE ODYSSEY OUTCOMES TRIAL

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    This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

    *Injection site reactions included itching, redness or swelling.2
    †In ten phase 3 controlled trials, involving patients with primary hypercholesterolemia and mixed dyslipidemia, the most common adverse reactions were local injection site reactions, upper respiratory tract signs and symptoms, and pruritus. Most common adverse reactions leading to treatment discontinuation in patients treated with Praluent® were local injection site reactions.1
    ADA=anti-drug antibodies; LDL-C=low-density lipoprotein cholesterol; NAb=neutralizing antibodies; Q2W=once every two weeks; Q4W=once every four weeks.

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