Alirocumab

Alirocumab Brand Name– Praluent

What is Alirocumab

Alirocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for adjunct treatment to diet, alone or in combination with other lipid-lowering therapies in adults with heterozygous familial hypercholesterolemia who require lowering of low-density lipoprotein cholesterol (LDL-C).

Alirocumab is also indicated for reducing the risk of myocardial infarction, stroke prophylaxis, and hospitalization for unstable angina in adults with cardiovascular disease.

During various clinical trials, alirocumab produced negative mean differences from placebo from baseline in LDL-C ranging from 43% to 58%.

In the Odyssey Outcomes study, alirocumab therapy was associated with a significant reduction in the primary composite outcome, which was defined as time to first occurrence of non-fatal myocardial infarction, fatal stroke, non-fatal stroke, coronary heart disease death, ischemic stroke, or unstable angina requiring hospitalization (p = 0.0003).

Serious hypersensitivity reactions including hypersensitivity vasculitis have occurred with use.

Alirocumab was FDA-approved in July 2015.

Indications

  • heterozygous familial hypercholesterolemia
  • myocardial infarction prophylaxis
  • stroke prophylaxis
  • unstable angina

Note: Alirocumab is recommended as second-line therapy in addition to maximally tolerated statin therapy in patients with clinical ASCVD and comorbidities that still require 25% or greater LDL reduction. Factors to consider include cost, benefit of ASCVD risk reduction, dosing frequency requirements, and administration by subcutaneous injection.

Side Effects

  1. angioedema
  2. antibody formation
  3. chest pain (unspecified)
  4. confusion
  5. cough
  6. diarrhea
  7. ecchymosis
  8. edema
  9. elevated hepatic enzymes
  10. erythema
  11. infection
  12. influenza
  13. injection site reaction
  14. memory impairment
  15. musculoskeletal pain
  16. myalgia
  17. pharyngitis
  18. pruritus
  19. sinusitis
  20. vasculitis

Monitoring Parameters

  • serum lipid profile

Contraindications

  • angioedema
  • breast-feeding
  • pregnancy
  • serious hypersensitivity reactions or anaphylaxis
  • vasculitis

Interactions

There are no drug interactions associated with Alirocumab products.

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