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Alirocumab – PCSK9 Inhibitor for Cholesterol Reduction

Alirocumab is a cholesterol-lowering medication belonging to the PCSK9 inhibitor class. It is used when conventional therapies are insufficient to control LDL levels.

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Things worth knowing about "Alirocumab"

Alirocumab is a cholesterol-lowering medication belonging to the PCSK9 inhibitor class. It is used when conventional therapies are insufficient to control LDL levels.

What is Alirocumab?

Alirocumab is a biotechnology-derived monoclonal antibody belonging to the class of PCSK9 inhibitors. It is marketed under the brand name Praluent and is indicated for lowering elevated LDL cholesterol levels in the blood. The medication is administered by subcutaneous injection and is approved for use in adults with specific lipid disorders.

Indications

Alirocumab is indicated for:

Primary hypercholesterolaemia (including familial and non-familial forms)
Mixed dyslipidaemia
Patients at high cardiovascular risk in whom statins are insufficient or not tolerated
Reduction of cardiovascular risk following acute coronary syndrome

Mechanism of Action

Alirocumab inhibits the enzyme PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9). Under normal conditions, PCSK9 binds to LDL receptors on the surface of liver cells and promotes their degradation. By blocking PCSK9, more LDL receptors remain available to remove LDL cholesterol from the bloodstream. This leads to a significant reduction in LDL cholesterol levels – by up to 60% compared to placebo in clinical trials.

Dosage and Administration

Alirocumab is administered as a subcutaneous injection, typically every two weeks. It is available as a prefilled pen or prefilled syringe. The standard dose is 75 mg every two weeks, which may be increased to 150 mg if the response is insufficient. A 300 mg dose for monthly administration is also approved. Patients can self-administer the injection after appropriate training.

Side Effects

Alirocumab is generally well tolerated. The most common side effects include:

Injection site reactions (redness, pain, swelling)
Nasopharyngitis (cold-like symptoms)
Influenza-like illness
Back pain

Rarer but potentially more serious side effects include allergic reactions and possible neurocognitive effects that were observed in some studies, the clinical significance of which is still being investigated.

Treatment Context

Alirocumab is frequently used as an add-on to statin therapy or as an alternative in cases of statin intolerance. The landmark ODYSSEY OUTCOMES trial demonstrated that alirocumab significantly reduces the risk of myocardial infarction, stroke, and cardiovascular death in patients following acute coronary syndrome. It therefore represents an important component of modern lipid-lowering therapy in high-risk patients.

References

Schwartz GG et al. – ODYSSEY OUTCOMES Investigators: Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. New England Journal of Medicine, 2018; 379:2097-2107.
European Medicines Agency (EMA): Praluent (Alirocumab) – Summary of Product Characteristics. EMA, 2015 (updated 2023). Available at: https://www.ema.europa.eu
Catapano AL et al. – 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. European Heart Journal, 2016; 37(39):2999-3058.

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