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FOURIER Trial | 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 your established CVD patients

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    Repatha® Plus a Statin Reduced the Risk of CV Events1,2

    Repatha® + statin was proven to reduce the risk of composite CV events by 20% in a median of only 2.2 years, and the benefit improved over time in the study1,2

    Key secondary endpoint: composite of time to first occurrence of CV death, MI, or stroke1,2

    • Primary composite endpoint of time to first occurrence of CV death, Ml, hospitalization for unstable angina, stroke, or coronary revascularization: HR 0.85 (95% Cl, 0.79-0.92; P<0.0001)1
    • Relative risk reductions for the primary and secondary composite endpoints were driven by a reduction in the risk of Ml: HR 0.73 (95% Cl, 0.65-0.82), stroke: HR 0.79 (95% Cl, 0.66-0.95), and coronary revascularization: HR 0.78 (95% Cl, 0.71-0.86)1,*

      *Not statistically significant.

    • Observed HR for CV death: 1.05 (95% Cl, 0.88-1.25) and hospitalizations due to unstable angina: 0.99 (95% Cl, 0.82-1.18)1

    The FOURIER CV Outcomes Trial: A double-blind, randomized, placebo-controlled, event-driven trial of 27,564 patients with established CVD and LDL-C ≥70 mg/dL and/or non–HDL-C ≥100 mg/dL, despite high- or moderate-intensity statin therapy. Patients received either subcutaneous injections of Repatha® (evolocumab 140 mg every 2 weeks or 420 mg once monthly) or placebo. The median baseline LDL-C was 92 mg/dL.1,2

    Meaningful Reduction of CV Risk Across FOURIER Subgroups

    • RECENT MI

      In a sub-analysis, Repatha® + statin lowered the risk of composite CV events in patients with a recent MI (<12 months)3,4

      RECENT MI Key secondary endpoint: composite of time to first occurrence of CV death, MI, or stroke3,4
      • Recent MI patients within 1 year of a heart attack have a higher CV risk3,5
      • ARR of 2.0% in the overall Repatha® CV Outcomes Trial study population was demonstrated at 36 months2
      • Observed HR for CV death in the primary analysis 1.05 (95% CI, 0.88-1.251)
    • PCI

      In a post-hoc analysis, Repatha® + statin lowered the risk of composite CV events in patients with prior PCI6,7

      Major CV events were the composite of coronary death, MI, or coronary revascularization6,7
      • Analysis of 17,073 patients with a prior PCI in the Repatha® CV Outcomes Trial6,7
      • ARR of 2.0% in the overall Repatha® CV Outcomes Trial study population was demonstrated at 36 months2
      • Observed HR for CV death in the primary analysis: 1.05 (95% CI, 0.88-1.25)1
      • Post-hoc analysis are exploratory and no statistical conclusions can be drawn
    • DIABETES

      In a post-hoc analysis, Repatha® + statin lowered the risk of composite CV events in patients with diabetes8,9

      PATIENTS WITH DIABETES Key secondary endpoint: composite of time to first occurrence of CV death, MI, or stroke8,9
      • Analysis of 11,031 patients with diabetes in the Repatha® CV Outcomes Trial1
      • For patients with diabetes: Primary composite efficacy endpoint of time to first occurrence of CV death, MI, hospitalization for unstable angina, stroke, or coronary revascularization: HR 0.83 (95% CI, 0.75-0.93); ARR: 2.7%9
      • ARR of 2.0% in the overall Repatha® CV outcomes trial study population was demonstrated at 36 months2
      • The observed HR for CV death was 1.05 (95% CI, 0.88-1.25) and for hospitalization due to unstable angina was 0.99 (95% CI, 0.82-1.18) from the primary analysis
      • Post-hoc analyses are exploratory and no statistical conclusions can be drawn
    • PAD

      In a post-hoc analysis, Repatha® + statin lowered the risk of composite CV events in patients with symptomatic PAD10

      Key secondary endpoint: composite of time to first occurrence of CV death, MI, or stroke10
      • 13% (n=3,642) of patients in the Repatha® CV Outcomes Trial were identified as having symptomatic PAD at baseline if they had intermittent claudication and an ankle-brachial index (ABI) of <0.85, or a prior peripheral vascular procedure10
      • Observed HR for CV death in primary analysis was 1.05 (95% CI, 0.88-1.25)1
      • ARR of 2.0% in the overall Repatha® CV Outcomes Trial study population was demonstrated at 36 months2
      • Post-hoc analysis are exploratory and no statistical conclusions can be drawn

    Achieve ACC Consensus Pathway Recommended Levels of LDL-C <55 mg/dL With Repatha® 1,2,11,*

    Adding Repatha® resulted in sustained and consistent LDL-C reduction2,14

    Repatha® + statin median LDL-C achieved at week 48 was 26 mg/dL1

    84% of patients taking Repatha® + statin achieved LDL-C <55 mg/dL at 4 weeks11
    • Are statins or ezetimibe enough?

      In a descriptive, retrospective analysis of 186,670 ASCVD patients with index LDL-C >70 mg/dL (mean index LDL-C of 108 mg/dL):

      Only

      21% of ASCVD patients

      who intensified statins achieved LDL-C values ≤70 mg/dL12,*

      Only

      23% of ASCVD patients

      who added ezetimibe to statin therapy achieved LDL-C values ≤70 mg/dL12,*

      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 record in the EMR database, which does not guarantee that the patient filled the prescription or used the medication. This was a descriptive, retrospective analysis that evaluated the associations between exposures and outcomes but no causal relationships can be established from this observation study.12

      *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.12

    *Threshold for very high-risk ASCVD patients.

    The 2022 ACC Consensus Decision Pathway (referred herein as ACC Consensus Pathway) was designed to address current gaps in care for LDL-C lowering to reducing ASCVD risk. This effort relies extensively on the evidence established by the 2013 ACC/AHA and 2018 AHA/ACC/Multisociety cholesterol guidelines, and provides further recommendations regarding the use of newer nonstatin therapies. It should be noted that this process did not involve formal systematic reviews, grading of evidence, or synthesis of evidence. The goal was to provide practical guidance for situations not covered by the previously published guidelines until the next round of formal review of scientific evidence.13

    References: 1. Repatha® (evolocumab) prescribing information, Amgen. 2. Sabatine MS, Giugliano RP, Keech AC, et al; FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376(18):1713-1722. doi:10.1056/NEJmoa1615664 3. Gencer B, Mach F, Murphy SA, et al. Efficacy of evolocumab on cardiovascular outcomes in patients with recent myocardial infarction: a prespecified secondary analysis from the FOURIER trial. JAMA Cardiol. 2020;5(8):952-957. doi:10.1001/jamacardio.2020.0882 4. Gencer B, Mach F, Murphy SA, et al. Efficacy of evolocumab on cardiovascular outcomes in patients with recent myocardial infarction: a prespecified secondary analysis from the FOURIER trial. JAMA Cardiol. 2020;5(8):952-957. Supplementary Online Content. doi:10.1001/jamacardio.2020.0882 5. Jernberg T, Hasvold P, Henriksson M, Hjelm H, Thuresson M, Janzon M. Cardiovascular risk in post-myocardial infarction patients: nationwide real world data demonstrate the importance of a long-term perspective. Eur Heart J. 2015;36(19):1163-1170. doi:10.1093/eurheartj/ehu505 6. Furtado RHM, Fagundes AA, Oyama K, et al. Effects of evolocumab in patients with prior percutaneous coronary intervention: an analysis from the FOURIER trial. Presented at: American Heart Association Scientific Sessions 2020; November 13-17, 2020. 7. Furtado RHM, Fagundes AA Jr, Oyama K, et al. Effect of evolocumab in patients with prior percutaneous coronary intervention. Circ Cardiovasc lnterv. 2022;15(3):e011382. doi:10.1161/circinterventions.121.011382 8. Sabatine MS, Leiter LA, Wiviott SD, et al. Cardiovascular efficacy & safety of evolocumab in diabetes, and risk of development of diabetes: an analysis from the FOURIER trial. Presented at: 53rd Annual Meeting of the European Association for the Study of Diabetes; Lisbon, Portugal; September 15, 2017. 9. 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 10. Bonaca MP, Nault P, Giugliano RP, et al. Low-density lipoprotein cholesterol lowering with evolocumab and outcomes in patients with peripheral artery disease: insights from the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk). Circulation. 2018;137(14):338-350. doi:10.1161/circulationaha.117.032235 11. Data on file, Amgen; 2022. 12. 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 13. 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. 2022;80(14):1366-1418. doi:10.1016/j.jacc.2022.07.006 14. O’Donoghue ML, Giugliano RP, Wiviott SD, et al. Long-term evolocumab in patients with established atherosclerotic cardiovascular disease. Circulation. 2022;146:1109-1119. doi:10.1161/CIRCULATIONAHA.122.061620

    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.