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CV Risk Reduction | Repatha® (evolocumab)
INDICATIONS

Repatha® is indicated:

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with established cardiovascular disease.. READ MORE

    • For US healthcare professionals

    Your established CVD patients don’t have time to wait for lower LDL-C1

    The incidence of clinical ASCVD is on the rise in the United States, with ~2.8 million new cases in 20192,*

    Stopwatch Icon

    Every

    ~40
    seconds in the United States:

    A patient has an MI3

    A patient has a stroke3

    Lipid Test Icon
    76%
    of very high risk ASCVD patients

    did not have a lipid test in the year following their most recent MI4,†

    LDL-C Icon
    80%
    of very high risk ASCVD patients

    treated with low-to-moderate-intensity statin ± ezetimibe did not achieve LDL-C < 55 mg/dL4,†

    LDL-C Icon
    74%
    of very high risk ASCVD patients

    treated with high intensity statin ± ezetimibe did not achieve LDL-C < 55 mg/dL4,†

    Primary Care Physician, J. Kyle Turnbo, MD
    If we are not reaching the recommended [LDL-C level] and we have already reached maximum statin therapy, we’ll go ahead and consider an introduction to Repatha®.

    – Dr. Turnbo

    Act Now. Established CVD patients are at risk of a heart attack or stroke.5,6

    • RECENT CV EVENT

    • PRIOR CV EVENT(S)

    • EVIDENCE OF ASCVD

    Hypothetical Repatha® (evolocumab) PatientActor Portrayal
    Recent CV Event and/or Procedure

    Actor Portrayal

    Recent CV Event and/or Procedure

    Clinical Factors
    Disease Progression
    • CV event <12 months
    • PCI or CABG
    LDL-C Range
    • 70-95 mg/dL
    Other Risk Factors
    • Diabetes
    • Hypertension
    • Obesity or metabolic syndrome (MetS)
    Statin History
    • Highest tolerated dose

    Help patients with a recent CV event reduce their risk of an MI, stroke, or coronary revascularization.

    Add Repatha®

    Hypothetical Repatha® (evolocumab) PatientActor Portrayal
    Prior CV Event(s) + Additional CV Risk Factors

    Actor Portrayal

    Prior CV Event(s) + Additional CV Risk Factors

    Clinical Factors
    Disease Progression
    • CV event >12 months
    LDL-C Range
    • 70-95 mg/dL
    Other Risk Factors
    • Diabetes
    • Hypertension
    • Obesity or metabolic syndrome (MetS)
    Statin History
    • Highest tolerated dose

    In patients with established CVD, diabetes is associated with a greater risk of having CV events.7,‡

    Add Repatha®

    Hypothetical Repatha® (evolocumab) PatientActor Portrayal
    Evidence of ASCVD

    Actor Portrayal

    Evidence of ASCVD

    Clinical Factors
    Evidence of ASCVD
    • Peripheral artery disease (PAD) or stable angina
    • AND
    • Elevated coronary artery calcium (CAC)
    LDL-C Range
    • 100-150 mg/dL
    CAC Score
    • >300 Agatston units (AU)
    Other Risk Factors
    • Diabetes
    • Hypertension
    • Obesity or metabolic syndrome (MetS)
    Statin History
    • Highest tolerated dose

    95% of patients with PAD are considered very high risk. Help them get to the recommended LDL-C level.8,§

    Add Repatha®

    • VERY HIGH RISK DEFINITION

      94% of patients with a history of major ASCVD events had additional risk factors that placed them in the very high-risk category8,‡

      2018/ACC/MULTISOCIETY GUIDELINE DEFINITION OF A VERY HIGH-RISK ASCVD PATIENT9

      Heart Icon

      Multiple major ASCVD events

      • Recent ACS (within the past 12 months)
      • History of MI (other than recent ACS event listed above)
      • History of ischemic stroke
      • Symptomatic PAD (claudication with ABI <0.85, or prior revascularization/amputation)
      or
      Risk Icon

      One major ASCVD event and multiple high-risk conditions

      • Age ≥65 years
      • Prior CABG or PCI outside major ASCVD event(s)
      • Diabetes mellitus
      • HeFH
      • CKD (eGFR 15-59 mL/min/1.73 m2)
      • Hypertension
      • Current smoking
      • History of CHF
      • Persistently elevated LDL-C (≥100 mg/dL [≥2.6 mmol/L] despite maximally tolerated statin therapy + ezetimibe)

    See How Repatha® Can Help Your Established CVD Patients Achieve Treatment Goals

    play icon

    Identifying patients who might be right for Repatha®

    Duration: 5:14 minutes

    Hear Dr. Shah share her insights and experience treating myocardial infarctions in patients with established CVD. Dr. Shah identifies patients who could benefit from Repatha® to lower LDL-C and the risk of another MI or stroke.

    *The data were taken from The Institute for Health Metrics and Evaluation’s Global Burden of Disease Study. The open source data were used to determine the incidence of new clinical ASCVD cases, defined as: ischemic heart disease, stroke, ischemic stroke, and peripheral artery disease.

    †Retrospective patient study from IQVIA using an anonymized patient claims data set encompassing nearly 5.4 million patients who experienced Ml and met criteria for VHR ASCVD. Data set from January 1, 2018, to December 31, 2022. 17.1% of patients were treated with low-to-moderate-intensity statin ± ezetimibe, 40.4% high-intensity statin ± ezetimibe, and 44.2% untreated with lipid-lowering therapy. LDL-C levels for this analysis were available for 441,736 VHR ASCVD patients following their most recent MI.

    ‡Data from the placebo arm of the FOURIER trial. CV event compromises, MI, stroke, or CV death.

    §A retrospective cohort study of 16,344 patients 19 years of age or older with a history of major ASCVD events using data from the MarketScan database. 5,919 patients had symptomatic PAD as their history of a major ASCVD event. Patients were followed from January 1, 2016 through December 31, 2017 for recurrent ASCVD events. Major ASCVD events included recent ACS, history other than a recent ACS, history of ischemic stroke, and symptomatic PAD.

    ACS, acute coronary syndrome; ASCVD, atherosclerotic cardiovascular disease; AU, Agatston units; CABG, coronary artery bypass graft; CAC, coronary artery calcium; CVD, cardiovascular diseases; IS, ischemic stroke; MI, myocardial infarction; PAD, peripheral arterial disease; PCI, percutaneous coronary intervention; TIA, transient ischemic attack.

    References: 1. Baigent C, Blackwell L, Emberson J, et al. Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376:1670-1681. 2. Data on file, Amgen; 2024. 3. Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics—2020 update: A report from the American Heart Association. Circulation. 2020;141(9):e139-e596. doi:10.1161/cir.0000000000000757. 4. Data on file, Amgen; 2023. 5. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 22022;80:1366-1418. 6. Bhatt DL, Eagle KA, Ohman EM, et al. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010;304(12):1350-1357. 7. Sabatine MS, Leiter LA, Wiviott SD, et al. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5:941-950. 8. Muntner P, Orroth KK, Mues KE, et al. Evaluating a simple approach to identify adults meeting the 2018 AHA/ACC cholesterol guideline definition of very high risk for atherosclerotic cardiovascular disease. Cardiovasc Drugs Ther. 2022;36(3):475-481. doi:10.1007/s10557-021-07167-1. 9. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73(24):e285-e350. doi:10.1016/j.jacc.2018.11.003.

    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.

    Adverse Reactions in Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

    From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

    Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).

    Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo.

    Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.

    Indications

    Repatha® is indicated:

    • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with established cardiovascular disease
    • as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C

    Please see full Prescribing Information.

    Important Safety Information

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