What is the indication for Repatha (Evolocumab)?

From the Guidelines

Repatha (Evolocumab) is indicated for individuals with established atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia who require additional lowering of LDL cholesterol despite receiving maximum tolerated statin therapy.

Key Points

• The FOURIER trial 1 demonstrated that evolocumab reduced LDL cholesterol by 59% and decreased the composite outcome of cardiovascular death, MI, stroke, hospitalization for angina, or revascularization by 15% in patients with established ASCVD.
• The ODYSSEY OUTCOMES trial 1 also showed that alirocumab, another PCSK9 inhibitor, reduced LDL cholesterol by approximately 48% and lowered the risk of major adverse cardiovascular events by 15% in patients with recent acute coronary syndrome.
• Evolocumab is administered via subcutaneous injection, either 140 mg every 2 weeks or 420 mg every month, and has been shown to be effective in reducing LDL cholesterol and cardiovascular risk in patients with ASCVD or familial hypercholesterolemia 1.
• The use of evolocumab on top of statin therapy has been associated with a significant reduction in cardiovascular events, without an increase in cognitive deficits or other major adverse effects 1.

Important Considerations

• Evolocumab is used as an adjunct to maximally tolerated statin therapy, and its use should be considered in patients who require additional LDL cholesterol lowering.
• The reduction in LDL cholesterol and cardiovascular risk with evolocumab is consistent across different patient populations, including those with diabetes mellitus 1.
• The safety and efficacy of evolocumab have been established in large clinical trials, and its use is recommended in patients with established ASCVD or familial hypercholesterolemia who require additional LDL cholesterol lowering.

From the FDA Drug Label

REPATHA is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with established cardiovascular disease 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 As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C As an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C

The indication for Repatha (Evolocumab) is to:

• Reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease
• Reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)
• Reduce LDL-C in pediatric patients aged 10 years and older with HeFH
• Reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH) 2 2

From the Research

Indication for Repatha (Evolocumab)

The indication for Repatha (Evolocumab) is for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD) and hyperlipidemia, including those with established ASCVD, such as those with a prior myocardial infarction (MI), prior stroke, or symptomatic peripheral artery disease, as well as those at high cardiovascular risk without a prior MI or stroke 3, 4, 5, 6, 7.

Patient Populations

Evolocumab is indicated for use in the following patient populations:

• Patients with ASCVD, including those with a prior MI, prior stroke, or symptomatic peripheral artery disease 6, 7
• Patients at high cardiovascular risk without a prior MI or stroke, including those with atherosclerosis or high-risk diabetes mellitus 3
• Patients with familial hypercholesterolemia, including those with heterozygous and homozygous familial hypercholesterolemia 4, 7

Lipid-Lowering Therapy

Evolocumab is used in combination with optimized lipid-lowering therapy, including statins, to reduce low-density lipoprotein cholesterol (LDL-C) levels and prevent major adverse cardiovascular events 3, 4, 5, 6, 7.

Key Benefits

The key benefits of evolocumab include:

• Significant reduction in LDL-C levels, with a median reduction of 59% compared to placebo 6
• Reduction in the risk of major cardiovascular events, including cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary revascularization 6, 7
• Improvement in lipid parameters, including apolipoproteins A1 and B, lipoprotein(a), non-high-density lipoprotein cholesterol, and triglycerides 4