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THE ROLE OF STATIN THERAPY

Statins play a pivotal role in establishing the linear relationship between LDL-C and CV event risk1,2

CV event rate by mean achieved LDL-C level with statin therapy, proven over 25 years of clinical trials1,2

Figure adapted from Raymond C, et al. Cleve Clin J Med. 2014;81:11-19.

Shows a scatterplot with best-fit line of major statin trials for secondary prevention of coronary heart disease events.

MORE CAN BE DONE

Statins alone may not be enough for recent myocardial infarction patients who remain at risk3

21% More than 1 in 5 post-MI patients had at least one additional MI, IS, UA, or PCI/CABG within 2 years.4

66% of patients in the United States with major ASCVD event(s) have elevated LDL-C ≥ 70 mg/dL.5



For very high-risk* patients who have suffered a recent myocardial infarction, updated ACC/AHA Guidelines recommend the addition of a PCSK9 inhibitor like Repatha® to further lower LDL-C and associated CV risk.3†

*Very high risk includes a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions.3

Class I: Add ezetimibe to maximal statin before adding PCSK9 inhibitor; Class IIa: If on clinically judged maximal LDL-C-lowering therapy and LDL-C ≥70 mg/dL, or non-HDL-C ≥100 mg/dL, adding a PCSK9 inhibitor is reasonable.3

THE RIGHT REPATHA® PATIENTS THE RIGHT REPATHA®

Identifying recent MI patients who need more than a statin alone

In adults with established CVD

Tony*

Tony, and patients like him, need more help protecting them from another CV event like a heart attack or stroke

*Hypothetical patient profile.

In adults with established CVD TONY*

Tony, and patients like him, need more help protecting them from another CV event like a heart attack or stroke

*Hypothetical patient profile.



Recent myocardial infarction


Presented to ER with NSTE-ACS, confirmed as NSTEMI as per elevated cardiac troponin


Underwent PCI within 24 hours of presentation and was admitted to the hospital

Discharge

  • Sent home with dietary/lifestyle recommendations
  • Prescribed the following:
    • Rosuvastatin 40 mg QD (up-titrated from 20 mg post MI)
    • Aspirin 81 mg QD
    • Ticagrelor 90 mg BID
    • Ramipril 10 mg
    • Carvedilol 6.25 mg BID




Medical History


  1 month prior to MI Follow-up post discharge
LDL-C 112 mg/dL 105 mg/dL
HDL-C 45 mg/dL 47 mg/dL
TG 95 mg/dL 90 mg/dL
BMI 29.3 27.9
Rosuvastatin 20 mg 40 mg
  • History of hypertension
  • Current smoker (undergoing smoking cessation program)
  • TC=170 mg/dL

Statins + Repatha®

The Repatha® CV Outcomes Study (FOURIER) was designed to evaluate CV risk reduction by dramatically lowering LDL-C6

FOURIER was a double-blind, randomized, placebo-controlled, event-driven trial in 27,564 adult patients with established cardiovascular disease and with LDL-C ≥70 mg/dL and/or non-HDL-C ≥100 mg/dL despite high- or moderate-intensity statin therapy. Patients were randomly assigned to receive Repatha® (140 mg every 2 weeks or 420 mg once monthly) or placebo. The median follow-up duration was 26 months.6


99%

of patients were receiving high- or moderateintensity statin therapy.7

≥40 to ≤85

year-old patients were enrolled.7

81%

of patients had already experienced ≥1 MI.7

92 mg/dL

was the median baseline LDL-C for enrolled patients.7



Patients were treated with other CV medications6:

  • Anti-platelet agents (93%)
  • Beta-blockers (76%)
  • ACE inhibitor (56%)
  • ARB (23%)

For patients with established CVD,

Repatha® added to a statin reduced the risk of CV events more than statins alone6,7

Key secondary endpoint: composite of cardiovascular death, myocardial infarction, or stroke6,7


Repatha® added to a statin reduced the risk of composite CV events by 20% in a median of 2.2 years, and the benefit improved over time.6

  • Primary composite endpoint of time to CV death, MI, hospitalization for unstable angina, stroke, or coronary revascularization: HR 0.85 (95% CI, 0.79-0.92; P<0.0001)6

MI

27% RRR6

Revascularization

22% RRR6



  • Stroke=21% RRR6
  • Key secondary composite endpoint of time to CV death, MI, or stroke: HR 0.80 (95% CI, 0.73-0.88; P<0.0001). ARR=2.0%6,7
  • Relative risk reductions for the primary and secondary composite endpoints were driven by a reduction in the risk of MI: HR 0.73 (95% CI, 0.65-0.82), stroke: HR 0.79 (95% CI, 0.66-0.95), and coronary revascularization: HR 0.78 (95% CI, 0.71-0.86)6

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)6

Repatha® added to a statin provided an ARR of 2.9% in patients with a recent MI8

When compared to the overall study population, a greater ARR was observed in patients with a qualifying MI <2 years8


ARR of 2.0% in the overall Repatha® CV Outcomes Trial study population was evaluated at 36 months6,7

  • Repatha® reduced the risk of CV death, MI, or stroke by 24% in patients with a qualifying MI <2 years ago8
  • Analysis of 81% (n=22,351) of patients in Repatha® CV Outcomes Trial with MI as their qualifying event; median time from MI to enrollment in Repatha® CV Outcomes Trial was 3.3 years7
  • The observed HR for CV death was 1.05 (95% CI, 0.88-1.25) from the primary analysis6

For your high-risk CVD patients,

Repatha® added to a statin reduces risk of MI by dramatically reducing LDL-C6




Lipids are one of the most modifiable risk factors for the prevention of CV events.9


Repatha® added to a statin reduced composite CV event rates regardless of baseline LDL-C.10


View CV event rate

Repatha® has demonstrated a consistent safety profile across more than 26,000 patients.11


View safety profile



ACC/AHA=American College of Cardiology/American Heart Association; ARB=angiotensin II receptor blocker; ARR=absolute risk reduction; ASCVD=atherosclerotic cardiovascular disease; BID=twice daily; BMI=body mass index; CABG=coronary artery bypass graft; CI=confidence interval; CV=cardiovascular; CVD=cardiovascular disease; HDL-C=high-density lipoprotein cholesterol; HR=hazard ratio; IS=ischemic stroke; LDL-C=low-density lipoprotein cholesterol; MI=myocardial infarction; NSTE-ACS=non-ST-segment elevation acute coronary syndrome; NSTEMI=non-ST-elevation myocardial infarction; PCI=percutaneous coronary intervention; PCSK9=proprotein convertase subtilisin/kexin type 9; PRN=as needed; QD=once daily; RRR=relative risk reduction; TC=total cholesterol; TG=triglycerides; UA=unstable angina.

References: 1. Raymond C, Cho L, Rocco M, et al. New guidelines for reduction of blood cholesterol: Was it worth the wait? Cleve Clin J Med. 2014;81:11-19. 2. Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994;34:1383-1389. 3. 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. J Am Coll Cardiol. 2019;73:e285-e350. 4. Li S, Peng Y, Wang X, et al. Cardiovascular events and death after myocardial infarction or ischemic stroke in an older Medicare population. Clin Cardiol. 2019;42:391-399. 5. Data on file, Amgen; 2020. 6. Repatha® (evolocumab) prescribing information, Amgen. 7. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722. 8. Sabatine MS, De Ferrari GM, Giugliano RP, et al. Clinical benefit of evolocumab by severity and extent of coronary artery disease: an analysis from FOURIER. Circulation. 2018;138:756-766. 9. Yusuf S, Hawken S, Ôunpuu S, et al; on behalf of the INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-controlled study. Lancet. 2004;364:937-952. 10. Data on file, Amgen; 2017. 11. Data on file, Amgen; 2017.

In established CVD patients, regardless of baseline LDL-C,

Repatha® added to a statin reduced the risk of composite CV events1



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Reference: 1. Data on file, Amgen; 2017.

Important Safety Information

Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.

Allergic Reactions: Hypersensitivity reactions (e.g. angioedema, rash, urticaria) have been reported in patients treated with Repatha®, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic 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 (including HeFH): The most common adverse reactions (>5% of patients treated with Repatha® and occurring 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.

Allergic reactions occurred in 5.1% and 4.7% of Repatha®‐treated and placebo‐treated patients, respectively. The most common allergic 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 occurring 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 assigned to Repatha® compared with 7.7% in those assigned to 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.