Why Choose Repatha®?

For adults with clinical ASCVD on maximally tolerated statin therapy,

Repatha® Every 2 Weeks Was Studied With The Most Common Statin Types1,2

Study 1

Study 1 study design Study 1 study design

In a multicenter, double-blind, randomized, placebo-controlled trial:1,3

  • Adult patients (18-80 yrs) requiring additional LDL-C lowering* were randomized to statin therapy

  • After a 4-week lipid stabilization period, a baseline LDL-C was obtained, and patients were then randomized to Repatha® or placebo3

  • Post-lipid stabilization period baseline characteristics for patients with ASCVD on maximum-dose statin therapy (atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg), n = 296:1

- Mean age = 63

- Gender = 33% female, 67% male

- Mean baseline LDL-C = 108 mg/dL

  • Primary endpoint was mean percent change from baseline in LDL-C at week 12, and secondary endpoints included percent change from baseline in other lipid parameters at week 12 and percent of patients achieving LDL-C < 70 mg/dL2

    Patients with clinical ASCVD were on atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg.


*Key exclusion criteria: patients who experienced one of the following within prior 6 months were excluded: MI/UA, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), or stroke; and planned cardiac surgery or revascularization.3

Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.2

For adults with clinical ASCVD on maximally tolerated statin therapy,

Repatha® Every 2 Weeks + a Statin Helped Patients Escape High LDL-C, With Up To 77% Greater LDL-C Reduction Than a Statin Alone1,4

Effect of Repatha® on LDL-C in individual statin arms1,4

Study 1

Study 1 results: effect of Repatha® on LDL-C in individual statin arms Study 1 results: effect of Repatha® on LDL-C in individual statin arms

Estimate based on multiple imputation model that accounts for treatment adherence.

  • Repatha® + a maximum-dose statin lowered LDL-C by a mean of 71% compared to a placebo + a statin1

  • Repatha® delivered additional LDL-C reductions regardless of statin type studied1

For adults with clinical ASCVD on maximally tolerated statin therapy,

Repatha® Every 2 Weeks Is a Path To Achieving an LDL-C < 70 mg/dL in up to 90% of Patients5

Percentage of patients achieving LDL-C < 70 mg/dL at week 125

Study 1

Study 1 results: percentage of patients achieving LDL-C < 70 mg/dL at week 12 Study 1 results: percentage of patients achieving LDL-C < 70 mg/dL at week 12
  • Mean baseline LDL-C after the lipid stabilization period was 108 mg/dL1

Please see study design details.

For adults with clinical ASCVD on maximally tolerated statin therapy,

Repatha® Every 2 Weeks + a Statin Helped Patients Lower Other Key Lipid Parameters1

Pooled analysis of treatment arms from study 11

Study 1

Study 1 results: pooled analysis of treatment arms on other key lipid parameters Study 1 results: pooled analysis of treatment arms on other key lipid parameters

Estimate based on multiple imputation model that accounts for treatment adherence.
Please see study design details.

APO = apolipoprotein; HDL = high-density lipoprotein; TC = total cholesterol.

References: 1. Repatha® (evolocumab) Prescribing Information, Amgen. 2. Robinson JG, Nedergaard BS, Rogers WJ, et al. JAMA. 2014;311:1870-1882. 3. Robinson JG, Rogers WJ, Nedergaard BS, et al. J Clin Cardiol. 2014;37:195-203. 4. Data on file, Amgen; 2015. 5. Data on file, Amgen; 2015. 6. Data on file, Amgen; 2016.

IMPORTANT SAFETY INFORMATION

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Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®.

Allergic reactions: Hypersensitivity reactions (e.g. 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 Repatha®-treated patients and occurring more frequently than placebo) in clinical trials in primary hyperlipidemia (including HeFH) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha®-treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to Repatha® treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for Repatha® and placebo, respectively).

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. The proportions of patients who discontinued treatment due to local injection site reactions in Repatha®-treated patients and placebo-treated patients were 0.1% and 0%, respectively.

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 safety profile of Repatha® in this trial was generally consistent with the safety profile described above in the 12- and 52-week controlled trials involving patients with primary hyperlipidemia (including HeFH). Serious adverse events occurred in 24.8% and 24.7% of Repatha®-treated and placebo-treated patients, respectively. Adverse events led to discontinuation of study treatment in 4.4% of patients assigned to Repatha® and 4.2% assigned to placebo. Common adverse reactions (>5% of patients treated with Repatha® and occurring more frequently than placebo) included 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 a potential for immunogenicity with Repatha®.

Please see full Prescribing Information.

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