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Evinacumab in Patients with Refractory Hypercholesterolemia.

Robert S Rosenson1, Lesley J Burgess1, Christoph F Ebenbichler1

  • 1From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).

The New England Journal of Medicine
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PubMed
Summary

Evinacumab significantly reduced low-density lipoprotein (LDL) cholesterol in patients with refractory hypercholesterolemia. This monoclonal antibody therapy demonstrated over 50% LDL reduction at maximum doses, offering a new treatment option.

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Area of Science:

  • Cardiology
  • Pharmacology
  • Genetics

Background:

  • Patients with refractory hypercholesterolemia have elevated low-density lipoprotein (LDL) cholesterol despite maximal lipid-lowering therapies, increasing atherosclerosis risk.
  • The efficacy and safety of evinacumab, a monoclonal antibody targeting angiopoietin-like 3, were previously unknown in this patient population.

Purpose of the Study:

  • To evaluate the efficacy and safety of subcutaneous and intravenous evinacumab in patients with refractory hypercholesterolemia.
  • To determine the impact of evinacumab on LDL cholesterol levels compared to placebo.

Main Methods:

  • A double-blind, placebo-controlled, phase 2 trial enrolled patients with refractory hypercholesterolemia.
  • Participants received varying doses of subcutaneous or intravenous evinacumab or placebo.
  • The primary endpoint was the percent change in LDL cholesterol from baseline at week 16.

Main Results:

  • Subcutaneous evinacumab (450 mg weekly) reduced LDL cholesterol by 56.0% compared to placebo (P<0.001).
  • Intravenous evinacumab (15 mg/kg every 4 weeks) reduced LDL cholesterol by 50.5% compared to placebo (P<0.001).
  • Serious adverse event incidence ranged from 3-16% across groups.

Conclusions:

  • Evinacumab significantly reduced LDL cholesterol levels in patients with refractory hypercholesterolemia.
  • The maximum dose of evinacumab achieved over a 50% reduction in LDL cholesterol.
  • Evinacumab shows promise as a treatment for refractory hypercholesterolemia.