Alirocumab

(Praluent®)

Praluent®

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Drug updated on 5/17/2024

Dosage FormInjection (subcutaneous; 75 mg/mL, 150 mg/mL)
Drug ClassProprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
  • Indicated as an 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.
  • Indicated as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
  • Indicated 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.

Summary
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  • Alirocumab (Praluent) is indicated for reducing the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. This medication is also used in combination with a diet or other low-density lipoprotein cholesterol (LDL-C)-lowering therapies in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), and homozygous familial hypercholesterolemia (HoFH). It is additionally recommended in combination with diet and other LDL-C-lowering therapies for pediatric patients aged 8 years and older with HeFH.
  • The study involved a total of 32 systematic reviews/meta-analyses related to Praluent.
  • In terms of efficacy among patients with Familial Hypercholesterolemia, both alirocumab and evolocumab demonstrated substantial effectiveness in reducing LDL-C levels by up to approximately 49.59% compared to placebo.
  • For patients with established cardiovascular disease, alirocumab has been noted specifically for its ability to reduce all-cause mortality risk, which wasn't significantly demonstrated by evolocumab. Both medications, however, significantly reduced the risks associated with myocardial infarction, coronary revascularization, and ischemic stroke.
  • Among diabetic patient subgroups, PCSK9 inhibitors like alirocumab or evolocumab resulted in a reduction of major adverse cardiovascular events by about 18%, while substantially improving lipid profiles.
  • The overall safety profile shows that PCSK9 inhibitors such as alirocumab are well-tolerated without any significant association towards increased risk factors such as sepsis, onset diabetes, or neurocognitive events across the studies reviewed providing reassurance on their safety usage.
  • Injection site reactions were more frequent with the administration of these drugs, but potential adverse effects like liver enzyme elevations, myopathy, or neurocognitive disorders did not significantly differ from control groups.
  • The efficacy and safety profiles of PCSK9 inhibitors were consistent across various subgroups, including those with different genetic backgrounds of FH and diabetic status. No significant differential response in LDL-C reduction efficacy was observed across races or specific genetic variants within the FH population, suggesting a broad applicability for these treatments.

Product Monograph / Prescribing Information

Document TitleYearSource
Praluent (alirocumab) Prescribing Information.2024Regeneron Pharmaceuticals, Inc., Tarrytown, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of alirocumab and evolocumab as proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in familial hypercholesterolemia: a systematic review and meta-analysis.2024Current Medicinal Chemistry
PCSK-9 Inhibitors and cardiovascular outcomes: a systematic review with meta-analysis.2023Cureus
Effect of different types and dosages of proprotein convertase subtilisin/kexin type 9 inhibitors on lipoprotein(a) levels: a network meta-analysis.2023Journal of Cardiovascular Pharmacology
PCSK9 inhibitors safely and effectively lower LDL after heart transplantation: a systematic review and meta-analysis.2023Heart Failure Reviews
The efficacy of PCSK9 inhibitors on major cardiovascular events and lipid profile in patients with diabetes: a systematic review and meta-analysis of randomized controlled trials. https://academic.oup.com/ehjcvp/advance-article-abstract/doi/10.1093/ehjcvp/pvad019/7087275?redirectedFrom=fulltext&login=false 2023 European Heart Journal Cardiovascular Pharmacotherapy2023European Heart Journal Cardiovascular Pharmacotherapy
The association between PCSK9 inhibitor use and sepsis: a systematic review and meta-analysis of 20 double-blind, randomized, placebo-controlled trials.2023The American Journal of Medicine
Reduction of cardiovascular risk using proprotein convertase subtilisin/kexin type 9 inhibitors in patients with acute coronary syndrome: a systematic review.2023Cureus
Effect of alirocumab and evolocumab on all-cause mortality and major cardiovascular events: a meta-analysis focusing on the number needed to treat.2022Frontiers in Cardiovascular Medicine
Network meta-analysis of randomized trials evaluating the comparative efficacy of lipid-lowering therapies added to maximally tolerated statins for the reduction of low-density lipoprotein cholesterol.2022Journal of the American Heart Association
Exploring the efficacy of alirocumab and evolocumab in reducing low-density lipoprotein (LDL) cholesterol levels in patients with familial hypercholesterolemia: a systematic review.2022Cureus
Effect of PCSK9 Inhibitor on blood lipid levels in patients with high and very-high CVD risk: a systematic review and meta-analysis.2022Cardiology Research and Practice
Efficacy and safety of alirocumab and evolocumab: a systematic review and meta-analysis of randomized controlled trials.2022European Heart Journal
Efficacy and safety of PCSK9 inhibition in cardiovascular disease: a meta-analysis of 45 randomized controlled trials.2022Cardiology Journal
Effect of PCSK9 inhibitor on blood lipid levels in patients with high and very-high CVD risk: a systematic review and meta-analysis.2022Cardiology Research and Practice
Incremental net benefit of lipid-lowering therapy with PCSK9 inhibitors: a systematic review and meta-analysis of cost-utility studies.2022European Journal of Clinical Pharmacology
Additive effects of ezetimibe, evolocumab, and alirocumab on plaque burden and lipid content as assessed by intravascular ultrasound: a PRISMA-compliant meta-analysis.2022Medicine
Latest clinical evidence about the effect of PCSK9 monoclonal antibodies in patients with familial hypercholesterolaemia: an updated meta-analysis.2022Endokrynologia Polska
Comparative efficacy of non-statin lipid-lowering therapies in patients with hypercholesterolemia at increased cardiovascular risk: a network meta-analysis.2022Current Medical Research and Opinion
The promising novel therapies for familial hypercholesterolemia.2022Journal of Clinical Laboratory Analysis
A systematic review and meta-analysis of therapeutic efficacy and safety of alirocumab and evolocumab on familial hypercholesterolemia.2021BioMed Research International
Effects of alirocumab on cardiovascular events and all-cause mortality: a systematic review and meta-analysis.2021Reviews in Cardiovascular Medicine
Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: a pooled analysis from 10 ODYSSEY phase 3 studies.2021European Journal of Preventive Cardiology
PCSK9 inhibitors for secondary prevention in patients with cardiovascular diseases: a Bayesian network meta-analysis.2021Cardiovascular Diabetology
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and the risk for neurocognitive adverse events: a systematic review, meta-analysis and meta-regression.2021International Journal of Cardiology
Impact of lowering low-density lipoprotein cholesterol with contemporary lipid-lowering medicines on cognitive function: a systematic review and meta-analysis.2021Cardiovascular Drugs and Therapy
A meta-analysis of medications directed against PCSK9 in familial hypercholesterolemia.2021Atherosclerosis
Meta-analysis of clinical outcomes of PCSK9 modulators in patients with established ASCVD.2021Pharmacotherapy
Indirect comparison of the efficacy and safety of alirocumab and evolocumab: a systematic review and network meta-analysis.2020European Heart Journal Cardiovascular Pharmacotherapy
PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.2020The Cochrane Database of Systematic Reviews
Efficacy and safety of PCSK9 monoclonal antibodies in patients at high cardiovascular risk: an updated systematic review and meta-analysis of 32 randomized controlled trials.2020Advances in Therapy
PCSK9 inhibitor therapy: a systematic review and meta-analysis of metabolic and cardiovascular outcomes in patients with diabetes.2019Diabetes, Obesity & Metabolism
Efficacy and safety of different doses of alirocumab in reducing low-density lipoprotein cholesterol levels: a network meta-analysis.2019Die Pharmazie
A meta-analysis of the effect of PCSK9-monoclonal antibodies on circulating lipoprotein (a) levels.2019American Journal of Cardiovascular Drugs
Efficacy and safety of alirocumab and evolocumab: a systematic review and meta-analysis of randomized controlled trials.2019European Heart Journal
Effects of PCSK9 inhibitors on LDL cholesterol, cardiovascular morbidity and all-cause mortality: a systematic review and meta-analysis of randomized controlled trials.2019Journal of Endocrinological Investigation

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