Repatha® Example Case Studies

Repatha® is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (CVD or HeFH) who require additional lowering of low density lipoprotein cholesterol (LDL-C).1

These patients may be appropriate for Repatha®. Select a patient below to see their clinical profile.*

Richard, 55 years old: MI Karen, 46 years old: HeFH Joe, 67 years old: Angina Mary, 65 years old: Stroke Dan, 50 years old: PAD Liz, 49 years old: HeFH and ASCVD Richard, 55 years old: MI Karen, 46 years old: HeFH Joe, 67 years old: Angina Mary, 52 years old: Stroke Dan, 50 years old: PAD Liz, 49 years old: HeFH and ASCVD

Richard, 55 Years Old

MI

Clinical ASCVD History

Hospitalized with MI 2 years ago

Secondary Factors

Current smoker
Abdominal obesity
(143 cm waist circumference)
Hypertension 135/92 mmHg
(amlodipine: 10 mg/day)

Current Lipid-Lowering Therapy

Rosuvastatin 20 mg/day

  • On atorvastatin 40 mg/day
    until 3 months ago; intolerant
    of 80 mg/day

LDL-C Level

107 mg/dL

Karen, 46 Years Old

HeFH

Clinical ASCVD History

HeFH

Secondary Factors

Hypertension 142/95 mmHg
(amlodipine 10 mg/day,
hydrochlorothiazide 25 mg/day)

Current Lipid-Lowering Therapy

Atorvastatin 80 mg/day,
ezetimibe 10 mg/day

LDL-C Level

191 mg/dL

Joe, 67 Years Old

MI

Clinical ASCVD History

Admitted to hospital with myocardial
infarction 7 months ago with
previous history of myocardial
infarction 3 years ago

Secondary Factors

Non-HDL: 112 mg/dL
Diabetes mellitus (metformin
2,000 mg/day, glipizide 20 mg/day)

Current Lipid-Lowering Therapy

Atorvastatin 80 mg/day,
aspirin 81 mg/day

LDL-C Level

78 mg/dL

Mary, 65 Years Old

STROKE

Clinical ASCVD History

Stroke 8 months ago

Secondary Factors

Hypertension 118/82 mmHg
(amlodipine 10 mg/day,
losartan 100 mg/day)
Clopidogrel 75 mg/day

Current Lipid-Lowering Therapy

Ezetimibe 10 mg/day
with documented inability
to tolerate any dose of statins
due to side effects

LDL-C Level

132 mg/dL

Dan, 50 Years Old

PAD

Clinical ASCVD History

Peripheral artery disease—calf and thigh
claudication with exertion

Secondary Factors

Current smoker (1 pack/day)
Hypertension 150/92 mmHg
(amlodipine 10 mg/day)

Current Lipid-Lowering Therapy

Rosuvastatin 40 mg/day

LDL-C Level

145 mg/dL

Liz, 49 Years Old

HeFH & ASCVD

Clinical ASCVD History

HeFH
Revascularization with two stents,
3 years ago

Secondary Factors

Tendon xanthomas, abdominal obesity
(93 cm waist circumference),
fasting plasma glucose 136 mg/dL

Current Lipid-Lowering Therapy

Atorvastatin 80 mg/day

LDL-C Level

210 mg/dL

*Hypothetical profile.

ASCVD = atherosclerotic cardiovascular disease; HeFH = heterozygous familial hypercholesterolemia; MI = myocardial infarction; PAD = peripheral artery disease.

Reference: 1. Repatha® (evolocumab) Prescribing Information, Amgen.

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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What is PCSK9?

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Why Repatha® Inhibits PCSK9

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How Repatha® Lowers LDL-C Levels

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Using the Pushtronex® System

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Using the SureClick® Autoinjector

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