Abstract 17005: Effects of Evolocumab Treatment on Serum Adrenal and Gonadal Hormone Levels: Results from the 52-week, Phase 3, Double-blind, Randomized, Placebo-controlled DESCARTES Study
Introduction: Evolocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), markedly reduces LDL-C in clinical studies. We evaluated adrenal and gonadal steroid hormone metabolism in evolocumab-treated patients, as LDL uptake may be an important source of cholesterol for steroid hormone synthesis.
Methods: DESCARTES (NCT01516879) randomized patients receiving lipid-lowering therapy to 52 weeks of subcutaneous monthly evolocumab 420 mg or placebo in a 2:1 ratio. We measured adrenal (cortisol and corticotropin [ACTH]) and gonadal hormones (estradiol and follicle stimulating hormone [FSH]) in females; testosterone and luteinizing hormone [LH] males) at baseline and at week 52. Results were stratified by minimum post-baseline LDL-C. We excluded patients receiving hormone replacement therapy, those with elevated baseline gonadotropins, and females older than 50 years from gonadal hormone analyses.
Results: There was no decrease in steroid or increase in pituitary stimulating hormones in evolocumab-treated patients, irrespective of minimum post-baseline LDL-C (Table).
Conclusion: Monthly evolocumab, alone or in combination with a statin and ezetimibe, did not adversely affect steroid hormone metabolism, even in patients with post-baseline LDL-C levels below 25 mg/dL.
Author Disclosures: D.J. Blom: Honoraria; Modest; Amgen; SanofiAventis; MSD; PharmaDynamics; AstraZeneca; Aegerion. Consultant/Advisory Board; Modest; MSD, Sanofi-Aventis, Aegerion. C. Djedjos: Employment; Significant; Amgen. K. Tsirtsonis: Employment; Significant; Amgen. S.M. Wasserman: Employment; Significant; Amgen. R. Scott: Employment; Significant; Amgen. E. Roth: Research Grant; Modest; Amgen. Speakers Bureau; Modest; Merck, AstraZeneca, Amarin. Consultant/Advisory Board; Modest; Regeneron, Sanofi.
- © 2014 by American Heart Association, Inc.