What is the indication for Praluent (alirocumab)?

From the Guidelines

Praluent (alirocumab) is recommended as an adjunct to maximally tolerated statin therapy for patients with atherosclerotic cardiovascular disease (ASCVD) to lower LDL cholesterol levels, with a demonstrated reduction in major adverse cardiovascular events 1. When considering Praluent, it is essential to note that it can reduce LDL-C by an additional 45% and 58% when administered at 75 mg and 150 mg SC every 2 weeks, respectively 1. The medication is generally well-tolerated, with common adverse effects including nasopharyngitis, injection site reactions, and influenza 1.

Key Considerations

• Contraindication: History of hypersensitivity to the medication 1
• Warnings/precautions: Hypersensitivity reactions, including anaphylaxis, have been reported; if a serious hypersensitivity reaction occurs, discontinue therapy and treat according to standard of care 1
• CV outcomes trials: The ODYSSEY Outcomes trial demonstrated that the addition of alirocumab reduced the primary endpoint of CHD death, MI, ischemic stroke, or hospitalization for UA in 18,600 post-ACS patients on evidence-based statin therapy 1

Administration and Monitoring

• Praluent is administered as a subcutaneous injection every 2 weeks 1
• Patients should be monitored regularly for signs and symptoms of hypersensitivity reactions and other adverse effects 1
• Regular monitoring of cholesterol levels is necessary to assess the medication's effectiveness and determine if dose adjustments are needed 1

From the FDA Drug Label

To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. As 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 other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.

The main uses of Praluent are:

• To reduce the risk of myocardial infarction, stroke, and unstable angina in adults with established cardiovascular disease.
• To reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
• To reduce LDL-C in adult patients with homozygous familial hypercholesterolemia (HoFH).
• To reduce LDL-C in pediatric patients aged 8 years and older with HeFH 2.

From the Research

Overview of Praluent

• Praluent, also known as alirocumab, is a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9) that is administered via subcutaneous injection every 2 weeks 3.
• It is used to treat hypercholesterolemia, particularly in patients with statin intolerance or inadequately-controlled low-density lipoprotein cholesterol (LDL-C) despite statin therapy 3, 4.

Efficacy of Praluent

• Praluent has been shown to be significantly more effective in reducing LDL-C compared to comparator agents, including placebo, ezetimibe, and statin therapy 3, 5, 6.
• In a 24-week study, alirocumab reduced mean LDL-C by 47% compared to 16% with ezetimibe 6.
• In another study, alirocumab reduced LDL-C by 45.0% compared to 14.6% with ezetimibe 5.

Safety and Tolerability of Praluent

• Praluent has been generally well tolerated in phase III trials, with no apparent increase in muscle-related adverse events compared to placebo 3.
• Injection site reactions were infrequent, occurring in less than 2% of alirocumab patients 6.
• Alirocumab was associated with significantly fewer skeletal muscle-related events compared to atorvastatin 5.

Comparison with Other Lipid-Lowering Therapies

• Praluent has been compared to ezetimibe in several studies, with alirocumab demonstrating greater LDL-C lowering efficacy 5, 6.
• The combination of alirocumab with statin therapy has been shown to improve lipid-lowering effects 7.
• Further studies are needed to establish the potential cardiovascular benefits of alirocumab and to compare its efficacy and safety with other lipid-lowering therapies 3, 4.