CSL112, a reconstituted, infusible, plasma-derived apolipoprotein A-I: safety and tolerability profiles and implications for management in patients with myocardial infarction

Davide Capodanno, Roxana Mehran, C. Michael Gibson, Dominick J. Angiolillo

Research output: Contribution to journalReview articlepeer-review

19 Scopus citations

Abstract

Introduction: The risk of major adverse cardiac events (MACE) remains elevated soon after a coronary event. High-density lipoprotein (HDL) cholesterol has been proposed as a target to reduce cardiovascular endpoints, but there is growing recognition that increasing the function of HDL may be more important than merely increasing its concentration. CSL112 is a reconstituted, infusible human plasma-derived apolipoprotein A-I (apoA-I) that increases cholesterol efflux capacity–an ex vivo measure of the ability of HDL to accept cholesterol from macrophages. Areas covered: This article reviews the pharmacology of CSL112 and its current clinical development status. Expert opinion: Clinical trials provide clear evidence that LDL cholesterol is involved in the mechanism of atherogenesis, but data for the protective role of HDL cholesterol remains inconclusive. The AEGIS-I trial suggests that the CSL112 elevates the quantity and the functionality of the apoA-I pool. The number of MACE in the AEGIS-I trial was low, but the study was not powered for efficacy. In aggregate, the favorable safety results of the AEGIS-I study encouraged the initiation of a large-scale phase 3 outcomes trial. Any benefit of CSL112, if proven on a large scale, must be weighed against the costs of the compound.

Original languageEnglish
Pages (from-to)997-1005
Number of pages9
JournalExpert Opinion on Investigational Drugs
Volume27
Issue number12
DOIs
StatePublished - 2 Dec 2018
Externally publishedYes

Keywords

  • AEGIS-I trial
  • CSL112
  • HDL
  • High-density lipoprotein
  • MACE
  • apoA-I
  • major adverse cardiac events
  • myocardial infarction

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