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Evolocumab Reference

Educational, not medical advice reference for Evolocumab: Metabolic; regulatory status, evidence posture, source review, and schedule notes. Als…

Plain English

What it is
Evolocumab, sold as Repatha, is an FDA-approved prescription medicine. It is a lab-made antibody that blocks a protein called PCSK9, which lets the body clear more of the "bad" LDL cholesterol out of the blood.
What people use it for
Doctors prescribe it to lower LDL cholesterol, often on top of a statin when cholesterol stays too high, and to lower the risk of heart attacks and strokes in adults at increased risk. It is also approved for people with inherited high-cholesterol conditions, including some children. It is given as an injection under the skin.
What the science shows
In a large trial of people with heart disease who were already on statins, it sharply lowered LDL cholesterol and cut the risk of major heart events over about two years. A separate study that looked at memory and thinking was reassuring.
The catch
This is a prescription drug that needs a doctor's oversight, not a supplement or an anti-aging product. The most common problems are injection-site reactions and, rarely, allergic reactions; it carries no boxed warning.

Reference summary

FOURIER (Sabatine 2017 NEJM, n=27,564) randomized statin-treated patients with established atherosclerotic cardiovascular disease to evolocumab vs placebo over a median 2.2 years. The primary 5-component MACE composite was reduced by 15 percent relative; the harder 3-component cardiovascular-death / MI / stroke composite was reduced by 20 percent. The median LDL-C in the evolocumab arm fell from 92 mg/dL to 30 mg/dL.

Regulatory and posture

Categories
Metabolic
Aliases
Repatha, AMG 145, Fully human IgG2 PCSK9-targeting monoclonal antibody
Evidence posture
human
Regulatory status
FDA-approved as Repatha (2015) as an adjunct to diet and maximally tolerated statin therapy for adults and pediatric patients aged 10 and older with HeFH; adjunct to other LDL-lowering therapies in HoFH; and to reduce risk of MI, stroke, and coronary revascularization in adults with established cardiovascular disease.
Content review status
label verified

Selected public sources

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