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

See More

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: The most common adverse reactions (> 5% of Repatha®-treated patients and more common than placebo) 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).

Adverse 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. 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%).

Neurocognitive events were reported in less than or equal to 0.2% in Repatha®-treated and placebo-treated patients.

In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1,988 patients treated with Repatha® had at least one LDL‑C value < 25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repatha® dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by Repatha® are unknown.

Musculoskeletal adverse reactions were reported in 14.3% of Repatha®-treated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for Repatha® and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).

Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha®.

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

The effect of Repatha® on cardiovascular morbidity and mortality has been published. Inclusion of the results in the approved labeling is under evaluation with the FDA.

Please see full Prescribing Information.

Back to Top

What is PCSK9?

Close

Why Repatha® Inhibits PCSK9

Close

How Repatha® Lowers LDL-C Levels

Close

Using the Pushtronex® System

Close

Using the SureClick® Autoinjector

Close
Close