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Efficacy and safety of PCSK9 monoclonal antibodies: an evidence-based review and update

Rasha Kaddoura1, Bassant Orabi1, Amar M Salam2

  • 1Hamad Medical Corporation, Heart Hospital Pharmacy, Doha, Ad Dawhah, Qatar.

Journal of Drug Assessment
|September 17, 2020
PubMed

Insights

Proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies effectively lower low-density lipoprotein cholesterol (LDL-C) in familial and non-familial hypercholesterolemia. These therapies are safe and reduce cardiovascular events, offering a vital option for patients not meeting lipid goals.

Area of Science:

  • Cardiovascular Medicine
  • Pharmacology
  • Lipidology

Background:

  • Dyslipidemia management is crucial for reducing cardiovascular (CV) risk.
  • Statins are primary therapy, but many patients fail to reach target low-density lipoprotein cholesterol (LDL-C) levels.
  • Proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies represent a novel class of lipid-lowering therapy (LLT).

Purpose of the Study:

  • To provide an updated, evidence-based review of PCSK9 monoclonal antibodies.
  • To assess the efficacy and safety of PCSK9 monoclonal antibodies.
  • To evaluate their role in treating familial and non-familial hypercholesterolemia.

Main Methods:

  • Searched PubMed for Phase III studies on PCSK9 monoclonal antibodies.
  • Reviewed US National Institutes of Health Registry and WHO International Clinical Trial Registry Platform for ongoing research.
  • Synthesized evidence on efficacy, safety, and CV event prevention.

Main Results:

  • PCSK9 monoclonal antibodies demonstrated significant LDL-C reduction as monotherapy or add-on LLT.
  • They proved effective and safe in treating both familial and non-familial hypercholesterolemia.
  • These antibodies contributed to the prevention of adverse cardiovascular events.

Conclusions:

  • PCSK9 monoclonal antibodies are recommended for dyslipidemia treatment to achieve LDL-C goals and reduce CV events.
  • Current evidence supports their use in specific patient populations.
  • Ongoing research may broaden their clinical application to more diverse patient groups.
Abstract

Keywords:
AlirocumabPCSK9anti-drug antibodybococizumabcardiovascular diseasesevolocumabhypercholesterolemianeurocognitive

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