Alirocumab brand name
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Alirocumab Brand Name: Praluent®
Introduction to Alirocumab (Praluent®)
Alirocumab, marketed under the brand name Praluent®, is a fully human monoclonal antibody developed by Regeneron Pharmaceuticals and Sanofi. It has been approved in the United States as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol (LDL-C).
Mechanism of Action: PCSK9 Inhibition
Alirocumab works by specifically binding to proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that downregulates liver low-density lipoprotein receptors (LDL-R). By inhibiting PCSK9, alirocumab increases the liver's ability to remove LDL-C from the blood, thereby significantly reducing LDL-C levels .
Efficacy in Reducing LDL Cholesterol
Clinical trials have demonstrated that alirocumab effectively reduces LDL-C levels in patients with hypercholesterolemia, including those with HeFH, both as monotherapy and in combination with statin therapy. In a randomized trial involving 2341 patients at high risk for cardiovascular events, alirocumab reduced LDL-C levels by 62% compared to placebo over 24 weeks, with the effect remaining consistent over 78 weeks.
Cardiovascular Outcomes
Alirocumab has also been shown to improve cardiovascular outcomes. In a study involving 18,924 patients who had experienced an acute coronary syndrome, those treated with alirocumab had a lower incidence of major adverse cardiovascular events compared to those receiving a placebo. Specifically, the hazard ratio for the composite primary endpoint (death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization) was 0.85, indicating a 15% reduction in risk.
Safety Profile
While alirocumab is generally well-tolerated, some adverse effects have been reported. These include injection-site reactions, myalgia, neurocognitive events, and ophthalmologic events. The incidence of these side effects was higher in the alirocumab group compared to the placebo group .
Conclusion
Alirocumab (Praluent®) is a significant advancement in the treatment of hypercholesterolemia and cardiovascular disease. By inhibiting PCSK9, it effectively lowers LDL-C levels and reduces the risk of cardiovascular events, making it a valuable option for patients who require additional lipid-lowering therapy beyond statins.
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