Praluent

Praluent, or alirocumab, is a human monoclonal antibody that inhibits the enzyme PCSK9. By blocking PCSK9, it prevents degradation of LDL receptors on liver cells, increasing receptor availability to clear low-density lipoprotein cholesterol (LDL-C) from the blood and thereby lowering LDL-C levels.

Indications and use: Praluent is indicated in adults as an adjunct to diet and maximally tolerated statin therapy for the treatment of primary hyperlipidemia or mixed dyslipidemia to reduce LDL-C. It is also used in adults with clinical atherosclerotic cardiovascular disease to reduce the risk of cardiovascular events when added to standard therapy. The drug has been studied in younger patients in some settings, with regulatory approvals varying by country.

Dosing and administration: Praluent is administered by subcutaneous injection. Common regimens include 75 mg or 150 mg every two weeks, with the option to increase to 150 mg every two weeks if LDL-C goals are not met. A once-monthly 300 mg dose (given as two injections at the same visit) is also available in some regimens.

Efficacy and outcomes: In patients on statin therapy, Praluent typically lowers LDL-C by about half or more, with additional reductions depending on dose. Outcome trials, such as those in patients with established cardiovascular disease after an acute event, have demonstrated a reduction in major adverse cardiovascular events when added to standard therapy in certain populations.

Safety and tolerability: Common adverse events include injection-site reactions, upper respiratory tract infections, influenza, and back pain. Hypersensitivity reactions and potential neurocognitive effects have been monitored, though such events are relatively uncommon. Patients should discuss risks and benefits with their healthcare provider.

Regulatory status and development: Praluent was developed by Regeneron and Sanofi and received regulatory approval in multiple regions beginning in the mid-2010s. Availability and labeling vary by country.