Evolocumab

(Repatha®)

Evolocumab

Drug updated on 5/17/2024

Dosage FormInjection (subcutaneous; 140 mg/mL, 420 mg/3.5 mL)
Drug ClassProprotein convertase subtilisin kexin type 9 inhibitors (PCSK9)
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicate in adults with established cardiovascular disease (CVD) to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease (CVD).
  • 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 diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C.
  • Indicated as an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty and may be inaccurate or outdated, with no liability accepted for reliance on it. Learn more.

  • Evolocumab (Repatha) is recommended for adults with established cardiovascular disease to minimize the risk of myocardial infarction, stroke, and coronary revascularization. It is also advised as an adjunct to diet alone or combined with other therapies for lowering low-density lipoprotein cholesterol (LDL-C) in cases of primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH), and homozygous familial hypercholesterolemia (HoFH). Furthermore, it is suitable for pediatric patients aged 10 years and older.
  • Thirty-two studies provided comprehensive information on the efficacy and safety of evolocumab compared to various controls such as placebo, ezetimibe, and statins.
  • All PCSK9 inhibitors, including evolocumab, have demonstrated a significant reduction in LDL-C levels in various patient populations, such as those with familial hypercholesterolemia (FH) and ASCVD, in comparison to placebo or other lipid-lowering therapies. This reduction was associated with a decreased incidence of major adverse cardiac events, indicating substantial cardiovascular benefits.
  • The safety profile of PCSK9 inhibitors was found to be comparable to placebos or other lipid-lowering agents, although injection site reactions were more frequently reported among users, but this was not significantly different from the control conditions.
  • Patients with both heterozygous and homozygous forms of Familial Hypercholesterolemia saw significant reductions in LDL-C from PCSK9 inhibitors, showing substantial benefits regardless of their genetic basis or prior statin use.
  • In post-heart transplant patients presenting with elevated LDL levels, these drugs effectively reduced LDL-C levels, indicating a potential role in attenuating coronary allograft vasculopathy and demonstrating utility in this unique patient group.
  • No significant variability was observed based on the presence of race or diabetes mellitus, suggesting broad applicability of the findings across diverse patient subgroups.
  • Head-to-head comparisons between PCSK9 inhibitors (e.g., evolocumab vs. alirocumab) and against other lipid-lowering strategies suggested comparable or superior efficacy in LDL-C reduction for PCSK9 inhibitors.

Product Monograph / Prescribing Information

Document TitleYearSource
Repatha (evolocumab) Prescribing Information.2021Amgen Inc., Thousand Oaks, CA

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
Proprotein convertase subtilisn/kexin type 9 inhibitors and small interfering RNA therapy for cardiovascular risk reduction: a systematic review and meta-analysis.2023PLoS One
Reduction of cardiovascular risk using proprotein convertase subtilisin/kexin type 9 inhibitors in patients with acute coronary syndrome: a systematic review.2023Cureus
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 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
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.2023European Heart Journal Cardiovascular Pharmacotherapy
Safety and effectiveness of evolocumab during acute and sub-acute phases of acute coronary syndrome (ACS): a systematic review and meta-analysis.2023Cureus
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
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
The promising novel therapies for familial hypercholesterolemia.2022Journal of Clinical Laboratory Analysis
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
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
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 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
Efficacy and safety of alirocumab and evolocumab: a systematic review and meta-analysis of randomized controlled trials.2022European Heart Journal
Additive effects of ezetimibe, evolocumab, and alirocumab on plaque burden and lipid content as assessed by intravascular ultrasound: a PRISMA-compliant meta-analysis.2022Medicine
Efficacy and safety of proprotein convertase subtilisin/kexin type 9 inhibitors as adjuvant treatments for patients with hypercholesterolemia treated with statin: a systematic review and network meta-analysis.2022Frontiers in Pharmacology
PCSK9 inhibitors for secondary prevention in patients with cardiovascular diseases: a Bayesian network meta-analysis.2022Cardiovascular Diabetology
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
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
A systematic review and meta-analysis of therapeutic efficacy and safety of alirocumab and evolocumab on familial hypercholesterolemia.2021BioMed Research International
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
Effects of evolocumab on low-density lipoprotein cholesterol, non-high density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) by race and ethnicity: a meta-analysis of individual participant data from double-blind and open-label extension studies.2021Journal of American Heart Association
Latest clinical evidence about the effect of PCSK9 monoclonal antibodies in patients with familial hypercholesterolaemia: an updated meta-analysis.2020Endokrynologia Polska
Indirect comparison of the efficacy and safety of alirocumab and evolocumab: a systematic review and network meta-analysis.2020European Heart Journal Cardiovascular Pharmacotherapy
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 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease (review).2020Cochrane Database for Systematic Reviews
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

Clinical Practice Guidelines