AHA/ACC = American Heart Association/American College of Cardiology; ARR = absolute risk reduction; ASCVD = atherosclerotic cardiovascular disease; CI = confidence interval; CV = cardiovascular; CVD = cardiovascular disease; ESC/EAS = European Society of Cardiology/European Atherosclerosis Society; HDL-C = high-density lipoprotein cholesterol; HR = hazard ratio; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction; PAD = peripheral artery disease; PCI = percutaneous coronary intervention; RRR = relative risk reduction;
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.