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Alirocumab Reference

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

Plain English

What it is
Alirocumab, sold as the brand Praluent, is an FDA-approved prescription medicine given as a shot under the skin. It is a lab-made antibody that blocks a protein called PCSK9, which lets the body pull more of the harmful LDL cholesterol out of the blood.
What people use it for
It is prescribed along with diet and statin pills to lower LDL cholesterol in people with high cholesterol, including an inherited form. It is also approved to lower the chance of heart attack, stroke, and chest pain serious enough to need a hospital stay in adults at increased risk.
What the science shows
In a large trial of nearly 19,000 people who had a recent heart event, adding alirocumab on top of a strong statin lowered major heart problems compared with a placebo over a median of about three years. The benefit looked larger in people who started with higher LDL cholesterol.
The catch
This is a prescription drug given by injection, not a supplement. The most common label side effects are reactions where the shot is given and flu-like illness, with muscle aches also reported in people who have heart disease.

Reference summary

ODYSSEY OUTCOMES (Schwartz 2018 NEJM, n=18,924) randomized patients with acute coronary syndrome in the prior 1 to 12 months to alirocumab vs placebo on top of high-intensity statin. The primary 4-component MACE composite was reduced by 15 percent relative over a median 2.8 years; pre-specified subgroup analysis suggested larger benefit in patients with baseline LDL-C at or above 100 mg/dL.

Regulatory and posture

Categories
Metabolic
Aliases
Praluent, REGN727, SAR236553, Fully human IgG1 PCSK9-targeting monoclonal antibody
Evidence posture
human
Regulatory status
FDA-approved as Praluent (2015) as an adjunct to diet and maximally tolerated statin therapy for adults with primary hypercholesterolemia (including HeFH); and to reduce risk of MI, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
Content review status
label verified

Selected public sources

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