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Alirocumab in high-risk patients: Observations from the open-label expanded use program.

Charles J Glueck1, Alan Brown2, Anne C Goldberg3

  • 1Jewish Hospital, Cincinnati, OH, USA.

Journal of Clinical Lipidology
|March 12, 2018
PubMed
Summary

Alirocumab effectively lowered LDL-C by 55% in high-risk patients with severe hypercholesterolemia. The drug demonstrated a safety profile consistent with prior trials, with few discontinuations due to adverse events.

Keywords:
AlirocumabCoronary heart diseaseExpanded useHeterozygous familial hypercholesterolemiaLDL-CODYSSEYPCSK9 inhibitorStatin intolerance

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Area of Science:

  • Cardiology
  • Pharmacology
  • Genetics

Background:

  • Severe hypercholesterolemia requires advanced lipid-lowering therapies.
  • Standard therapies are often insufficient for high-risk patients.
  • Alirocumab targets PCSK9 to reduce LDL-C.

Purpose of the Study:

  • Evaluate alirocumab's safety and efficacy in high-risk patients.
  • Assess early use of proprotein convertase subtilisin/kexin type 9 inhibitors.
  • Provide real-world data before commercial availability.

Main Methods:

  • Open-label alirocumab (150 mg every 2 weeks) for 24 weeks.
  • Enrolled patients with heterozygous familial hypercholesterolemia (HeFH) and/or coronary heart disease (CHD).
  • Included patients with baseline LDL-C ≥160 mg/dL on maximally tolerated lipid-lowering therapy, including statins or those with statin intolerance.

Main Results:

  • 100 patients enrolled; 64% had CHD, 61% had HeFH.
  • Alirocumab reduced LDL-C by 55% (from 221 mg/dL to 102 mg/dL).
  • 61% experienced treatment-emergent adverse events; 3% led to discontinuation; no deaths.

Conclusions:

  • Alirocumab demonstrated significant LDL-C reduction in high-risk patients.
  • Safety and efficacy align with findings from placebo-controlled ODYSSEY trials.
  • Supports alirocumab's role in managing severe hypercholesterolemia.