AMGEN and Repatha at ACC

Repatha® has a demonstrated safety profile
in over 27,000 patients1

The Repatha® CV Outcomes Trial demonstrated the long-term
safety of Repatha® added to a statin over a median of 2.2 years1-3

 
Repatha® + statin
n = 13,784
26 mg/dL
Median
achieved LDL-C*
Placebo + statin
n = 13,780
89 mg/dL
Number of patients n = 13,769 n = 13,756
Adverse events (% of patients)
Diabetes 8.8 8.2
Adjudicated case of new-onset diabetes 8.1 7.7
Nasopharyngitis 7.8 7.4
Upper respiratory tract infection 5.1 4.8
Muscle-related event 5.0 4.8
Allergic reaction 3.1 2.9
Injection-site reaction 2.1 1.6
Cataract 1.7 1.8
Neurocognitive event 1.6 1.5
Rhabdomyolysis 0.1 0.1

  • Hemorrhagic stroke: 0.21% Repatha® + statin (n = 13,784), 0.18% placebo + statin (n = 13,780)2
  • *Median LDL-C achieved at 48 weeks.2

    The total numbers of patients were 8,337 in the Repatha® + statin group and 8,339 in the placebo + statin group because patients with prevalent diabetes at the start of the trial were excluded.2

    Long-term safety

    Repatha® demonstrated a consistent safety profile over a 5-year period
    in an open-label extension of primary hyperlipidemia trials up to 5 years4,*
    • Reported AE rates were generally consistent with AE rates from FOURIER and other phase 3 trials1,4
    • AE rates remained consistent over the treatment course4
    • Discontinuation rate due to AEs was 1.4%/year4

    *1,255 patients (randomized 2:1 to Repatha® + SOC or SOC alone).4

    Cognitive function

    Lowering LDL-C with Repatha®
    did not impair cognitive function1
    EBBINGHAUS studied 1,974 patients
    from the Repatha® CV Outcomes Trial1
    • Patients were assessed using neuropsychological function tests over a median follow-up of 19 months1
    • Noninferiority in select cognitive function domains was observed between Repatha® and placebo when added to statin1,2

    AE = adverse event; CV = cardiovascular; LDL-C = low-density lipoprotein cholesterol; SOC = standard of care.

    References: 1. Repatha® (evolocumab) prescribing information, Amgen. 2. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722. 3. Data on file, Amgen:2017. 4. Koren MJ, Sabatine MS, Giugliano RP, et al. Long-term efficacy and safety of evolocumab in patients with hypercholesterolemia. J Am Coll Cardiol. 2019;74:2132-2146.

    IMPORTANT SAFETY INFORMATION
    • Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.
    • Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.

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    Please see full Prescribing Information.