Primary Study Overview
Primary Study Overview
Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk
Repatha® added to a statin was studied in established CVD patients who were at risk for CV events1
Explore the FOURIER study, a large CV outcomes trial that helped to inform the latest AHA/ACC Guideline1,2
with established CVD and LDL-C ≥70 mg/dL and/or non-HDL-C ≥100 mg/dL despite high- or moderate-intensity statin therapy1
FOURIER was a double-blind, randomized, placebo-controlled, event-driven trial1
Patients received either subcutaneous injections of Repatha® (140 mg every 2 weeks or 420 mg once monthly) or placebo1
Patients on stable background lipid-lowering therapy had a median baseline LDL-C of 92 mg/dL1
Patients were aged ≥40 to ≤85 years
with prior MI, stroke, or symptomatic PAD3,*
92 mg/dL LDL-C
median baseline for enrolled patients1
of patients had previously experienced ≥1 M11
of patients were receiving high- or moderate-intensity statin therapy1
of patients in the Repatha® arm were on high-intensity statins3
*Symptomatic peripheral arterial disease (history of claudication with ABI <0.85 or previous revascularization or amputation).2
Count on Repatha®
for your patients
who need more to achieve ACC/AHA guideline-recommended LDL-C <70 mg/dL1,2
Adding Repatha® to a statin can dramatically lower LDL-C in just 4 weeks3
Repatha® + statin lowered LDL-C by an average of
in 12 weeks1
of patients achieved LDL-C ≤70 mg/dL at 48 weeks3
ADD REPATHA® NOW TO PROVIDE SUSTAINED LDL-C REDUCTION1
For patients with established CVD
Repatha® added to a 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 time1,3
HR 0.80 (95% CI, 0.73-0.88; P < 0.0001) ARR = 2.0% 1,3
FOURIER subanalysis: recent MI
In a FOURIER subanalysis, statin + Repatha® provided greater ARR for patients who suffered an MI within 1 year compared to patients with a more distant MI4
Key secondary composite endpoint of time to first occurrence of CV death, MI, or stroke4 HR 0.75 (95% CI, 0.62-0.91) (n = 5,711)
For recent MI patients ARR = 3.2%4
For distant Ml patients ARR = 1.3%4
Observed HR for CV death: 1.05 (95% CI, 0.88-1.25) from the primary analysis1
FOURIER post-hoc subanalysis: patients with prior PCI
Repatha® + a statin provided a greater ARR in ASCVD patients with prior PCI compared to those without PCI8,9
Prior PCI | ARR = 2.8%9
No Prior PCI | ARR = 0.3%9
* Major CV events were the composite of coronary death, MI, or coronary revascularization.9
Guideline LDL-C Levels
FOURIER subanalysis: recommended LDL-C levels
AHA/ACC- & ESC/EAS-RECOMMENDED LDL-C LEVELS WERE ACHIEVED FOR MOST
Achievement of guideline-recommended LDL-C levels at 4 weeks in patients with recent MI (≤12 months)4
LDL-C ≤40 mg/dL
2019 ESC/EAS Guideline for patients experiencing second event within 2 years7
LDL-C ≤55 mg/dL
2019 ESC/EAS Guideline and 2022 ACC Consensus Pathway7
LDL-C ≤70 mg/dL
2018 AHA/ACC Guideline2
1. Repatha® (evolocumab) prescribing information, Amgen. 2. 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:e285-e350. 3. 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;376:1713-1722. 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. May 20, 2020:e200882. 5. Wang Y, Li J, Zheng X et al. Risk factors associated with major cardiovascular events 1 year after acute myocardial infarction. JAMA Netw Open. 2018;1:e181079. 6. 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;36:1163-1170. 7. Mach F, Baigent C, Catapano AL, et al; ESC Scientiﬁc Document Group. 2019 ESC EAS guidelines for the management of dyslipidaemias: lipid modiﬁcation to reduce cardiovascular risk. Eur Heart J. 2020;47:111-188. 8. 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. 9. Furtado RH, Fagundes AA, Oyama K, et al. Effects of evolocumab in patients with prior percutaneous coronary intervention: an analysis from the Fourier trial. Circulation. 2020;142:A16688. 10. Data on ﬁle, Amgen; 2017.
CVD = cardiovascular disease; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction.
LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction.
ACS = acute coronary syndrome; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction; PCSK9 = proprotein convertase subtilisin/kexin type 9.
Reference: 1. Repatha® (evolocumab) prescribing information, Amgen.
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®.
Please see full Prescribing Information.