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[PCSK9 inhibitors : Recommendations for patient selection].

U Laufs1, F Custodis2, C Werner2

  • 1Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, IMED Geb. 41.1, Universitätsklinikum des Saarlandes, 66421, Homburg/Saar, Deutschland. ulrich.laufs@uks.eu.

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New PCSK9 inhibitors, alirocumab and evolocumab, effectively lower LDL-C by 50-60% when added to statins. These well-tolerated therapies offer a new option for high-risk patients.

Keywords:
CholesterolProprotein convertase subtilisin-kexin type 9ReviewRiskSafety

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Area of Science:

  • Cardiovascular Medicine
  • Pharmacology

Background:

  • Elevated low-density lipoprotein cholesterol (LDL-C) is a major cardiovascular risk factor.
  • Statins and ezetimibe are standard lipid-lowering therapies, but some patients require additional treatment.
  • Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors represent a novel therapeutic class.

Purpose of the Study:

  • To evaluate the efficacy and safety of subcutaneous PCSK9 inhibitors (alirocumab and evolocumab).
  • To assess the role of PCSK9 inhibition in patients with refractory hypercholesterolemia.
  • To identify patient populations who may benefit most from PCSK9 inhibitor therapy.

Main Methods:

  • Subcutaneous administration of alirocumab or evolocumab every 2 or 4 weeks.
  • Addition of PCSK9 inhibitors to maximally tolerated statin and/or ezetimibe therapy.
  • Assessment of LDL-C reduction and safety profile compared to placebo.

Main Results:

  • PCSK9 inhibitors reduced LDL-C by 50-60% in addition to existing therapies.
  • The therapies were well-tolerated, with a safety profile comparable to placebo in published studies.
  • Long-term outcome data and cardiovascular event information are pending from ongoing trials.

Conclusions:

  • PCSK9 inhibitors are a safe and effective option for selected high-cardiovascular-risk patients with persistently high LDL-C.
  • Ideal candidates include patients with familial hypercholesterolemia and those experiencing statin-associated muscle symptoms (SAMS).
  • Further data on long-term safety and cardiovascular outcomes are anticipated.