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

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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
27564
patients
with established CVD and LDL-C ≥70 mg/dL and/or non-HDL-C ≥100 mg/dL despite high- or moderate-intensity statin therapy1
STUDY DESIGN
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 therapy1
FOURIER was a double-blind, randomized, placebo-controlled, even-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
81%
of patients had previously experienced ≥1 MI1
99%
of patients were receiving high- or moderate-intensity statin therapy1
70%
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
63%
in 12 weeks1
87
%
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 REDUCED THE RISK OF CV EVENTS MORE THAN STATINS ALONE1
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
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
Key secondary composite endpoint of time to first occurrence of CV death, MI, or stroke
HR 0.80 (95% CI, 0.73-0.88; P < 0.0001) ARR = 2.0%1,3
• Primary composite endpoint of time to first occurrence of CV death, MI, hospitalization for unstable angina, stroke or coronary revascularization: HR 0.85 (95% CI, 0.79-0.92; P < 0.0001)1
MI: 27% RRR1
Revascularization: 22% RRR1
Stroke: 21% RRR1
• 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,*
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
*Not statistically significant
FOURIER subanalysis: recent MI
HELP PREVENT ANOTHER MI: PATIENTS WITHIN 1 YEAR OF THEIR MOST RECENT MI HAVE A HIGHER CV RISK4-6
In a FOURIER subanalysis, statin + Repatha® provided greater AAR for patients who suffered an MI within 1 year compared to patients with a more distant MI4
In a FOURIER subanalysis, statin + Repatha® provided greater ARR for patients who suffered an MI within 1 year compared to patients with a more distinct MI4
RECENT MI
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 MI patients ARR = 1.3%4
ARR of 2.0% in the overall Repatha® CV Outcomes Trial study population was evaluated at 36 months3
• Analysis of 81% (N = 22,320) of patients in Repatha® CV Outcomes Trial with a prior MI4
• 5,711 patients who experienced an MI within 1 to 12 months of randomization were compared to 16,609 patients with a more distant MI (more than 12 months prior to randomization)4
Observed HR for CV death: 1.05 (95% CI, 0.88-1.25) from the primary analysis1
FOURIER subanalysis: target LDL-C levels
AHA/ACC- & ESC/EAS- RECOMMENDED LDL-C LEVELS WERE ACHIEVED FOR MOST PATIENTS2,4,7
%
64
0
%
FOURIER subanalysis: target LDL-C levels
AHA/ACC- & ESC/EAS-RECOMMENDED LDL-C LEVELS WERE ACHIEVED FOR MOST PATIENTS2,4,7
Achievement of guideline-recommended LDL-C levels at 4 weeks in patients with recent MI (≤12 months)4
LDL-C ≤40 mg/dL
ESC/EAS Guideline for patients experiencing second event within 2 years7
%
84
5
%
FOURIER subanalysis: target LDL-C levels
AHA/ACC- & ESC/EAS-RECOMMENDED LDL-C LEVELS WERE ACHIEVED FOR MOST PATIENTS2,4,7
Achievement of guideline-recommended LDL-C levels at 4 weeks in patients with recent MI (≤12 months)4
LDL-C ≤55 mg/dL
ESC/EAS Guideline7
%
92
18
%
FOURIER subanalysis: target LDL-C levels
AHA/ACC- & ESC/EAS-RECOMMENDED LDL-C LEVELS WERE ACHIEVED FOR MOST PATIENTS2,4,7
Achievement of guideline-recommended LDL-C levels at 4 weeks in patients with recent MI (≤12 months)4
LDL-C ≤70 mg/dL
AHA/ACC Guideline2
FOURIER post-hoc subanalysis: patients with prior PCI
REPATHA® ADDED TO A STATIN REDUCED MAJOR CV EVENTS* IN PATIENTS WITH A PRIOR PCI8
Repatha® + a statin provided a greater ARR in ASCVD patients with prior PCI compared to those without PCI8,9
*Major CV events were the composite of coronary death, MI, or coronary revascularization.
FOURIER post-hoc subanalysis: patients with prior PCI
REPATHA® ADDED TO A STATIN REDUCED MAJOR CV EVENTS* IN PATIENTS WITH A PRIOR PCI8
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
• ARR of 2.0% in the overall Repatha® CV Outcomes Trial study population was demonstrated at 36 months3
• Analysis of 62% (N = 17,073) of patients with prior PCI in Repatha® CV Outcomes Trial9
• Comparison of 17,073 patients with prior PCI versus 10,455 patients without prior PCI in the Repatha® and placebo arms of the Repatha® CV Outcomes Trial8
• Observed HR for CV death in the primary analysis: 1.05 (95% CI, 0.88-1.25)1
• Post hoc analyses are exploratory and no statistical conclusions can be drawn
* Major CV events were the composite of coronary death, MI, or coronary revascularization.9
Outcomes by baseline LDL-C
REGARDLESS OF BASELINE LDL-C, REPATHA® ADDED TO A STATIN CONSISTENTLY REDUCED THE RISK OF COMPOSITE CV EVENTS10
Outcomes by baseline LDL-C
REGARDLESS OF BASELINE LDL-C LEVEL, REPATHA® ADDED TO A STATIN CONSISTENTLY REDUCED THE RISK OF COMPOSITE CV EVENTS10
Key secondary endpoint: composite of CV death, MI, or stroke10
THE SAFETY PROFILE OF REPATHA® HAS BEEN DEMONSTRATED IN OVER 27,000 PATIENTS1,*
*In the CV outcomes trial (patients randomized to Repatha® or placebo)
The Repatha® CV Outcomes Trial demonstrated the long-term safety of Repatha® added to a statin over a median of 2.2 years3
THE SAFETY PROFILE OF REPATHA® HAS BEEN DEMONSTRATED IN OVER 27,000 PATIENTS1,*
The Repatha® CV Outcomes Trial demonstrated the long-term safety of Repatha® added to a statin over a median of 2.2 years3
Repatha® CV Outcomes Trial: Adverse events and Laboratory test results1,3,10

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;

REFERENCES:

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.

Primary Study Overview
Study Design
Patient Characteristics
LDL-C Reductions
CV Outcomes
Recent MI
Guideline LDL-C Levels
PCI Subanalysis
Baseline LDL-C Subgroup Analysis
FOURIER Safety
Glossary & References

test

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
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®.

Please see full Prescribing Information.

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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®.

Please see full Prescribing Information.