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CV Risk Reduction | Repatha® (evolocumab)
INDICATIONS

Repatha® is indicated:

  • In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization... READ MORE

    • For US healthcare professionals

    IT’S TIME WE REDUCE THE RISK OF MI, STROKE, AND CORONARY REVASCULARIZATION1-3

    An Estimated 14.7 Million US Adults Had a History of ASCVD4

    Stopwatch Icon

    Every

    ~40
    seconds in the United States:

    A patient has an MI1

    A patient has a stroke1

    Lipid Test Icon
    73%
    of the patients

    hospitalized for their first Ml DID NOT have a lipid test within 90 days following discharge5

    LDL-C Icon
    79%
    of ASCVD patients

    who intensified statins DID NOT achieve LDL-C values ≤70 mg/dL6,*

    LDL-C Icon
    77%
    of ASCVD patients

    who added ezetimibe to statin therapy DID NOT achieve LDL-C values ≤70 mg/dL6,*

    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. These Established CVD Patients Are at Risk7

    • RECENT CV EVENT

    • PRIOR CV EVENT(S)

    • EVIDENCE OF ASCVD

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

    Recent CV Event and/or Procedure

    Clinical Factors
    Disease Progression
    • CV event <12 months
      • IS or TIA
    • 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 chance of an MI, stroke, or coronary revascularization.

    Add Repatha®

    Hypothetical Repatha® (evolocumab) Patient
    Prior CV Event(s) + Another CV Risk Factor

    Prior CV Event(s) + Another CV Risk Factor

    Clinical Factors
    Disease Progression
    • CV event >12 months
      • History of MI
    • 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

    In patients with ASCVD, diabetes is associated with a greater risk of having CV events.7,†

    Add Repatha®

    Hypothetical Repatha® (evolocumab) Patient
    Evidence of ASCVD

    Evidence of ASCVD

    Clinical Factors
    Evidence of ASCVD
    • PAD or stable angina
    • AND
    • Elevated CAC
    LDL-C Range
    • 100-150 mg/dL
    CAC Score
    • >300 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,‡

      AHA/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® (evolocumab)

    Duration: 5:14 minutes

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

    *In a descriptive, retrospective analysis of 186,670 patients with ASCVD with index LDL-C >70 mg/dL (mean index LDL-C of 108 mg/dL). Baseline statin intensity: Among the 75,523 patients with ASCVD treated at baseline, 12.18% were on low statin intensity, 58.4% were on moderate statin intensity, 20.6% were on high statin intensity, and 8.8% were treated with other lipid-lowering agents. Patients were identified between January 1, 2012 and August 31, 2014, using the IQVIA US ambulatory electronic medical record database. Treatment exposure to statin and/or ezetimibe was based on observation of a valid prescription recorded in the EMR database, which does not guarantee that the patient filled the prescription or used the medication.

    †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; AU, Agatston units; CABG, coronary artery bypass graft; CAC, coronary artery calcium; IS, ischemic stroke; MI, myocardial infarction; PAD, peripheral arterial disease; PCI, percutaneous coronary intervention; TIA, transient ischemic attack.

    References: 1. 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 2. Salah HM, Minhas AMK, Khan MS, et al. Causes of hospitalization in the USA between 2005 and 2018. Eur Heart J Open. 2021;1(1):oeab001. doi:10.l093/ehjopen/oeab001 3. Punekar RS, Fox KM, Richhariya A, et al. Burden of first and recurrent cardiovascular events among patients with hyperlipidemia. Clin Cardiol. 2015;38(8):483-491. doi:10.1002/clc.22428 4. McKinley EC, Bittner VA, Brown TM, et al. The projected impact of population-wide achievement of LDL cholesterol <70 mg/dL on the number of recurrent events among US adults with ASCVD. Cardiovasc Drugs Ther. 2023;37(1):107-116. doi:10.1007/s10557-021-07268-x 5. Levintow SN, Reading SR, Noshad S, et al. Lipid testing trends before and after hospitalization for myocardial infarction among adults in the United States, 2008-2019. Clin Epidemiol. 2022;14:737-748. doi:10.2147/clep.s361258 6. Chen C-C, Rane PB, Hines DM, Patel J, Harrison DJ, Wade RL. Low-density lipoprotein cholesterol outcomes post-non-PCSK9i lipid-lowering therapies in atherosclerotic cardiovascular disease and probable heterozygous familial hypercholesterolemia patients. Ther Clin Risk Manag. 2018;14:2425-2435. doi:10.2147/tcrm.s180783 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(12):941-950. doi:10.1016/S2213-8587(17)30313-3 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

    Contraindications: 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:

    • In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
    • 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

    Contraindications: 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®.

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