Effects of evolocumab therapy and low LDL-C levels on vitamin E and steroid hormones in Chinese and global patients with type 2 diabetes.

Autor: Blom DJ; University of Cape Town Cape Town South Africa., Chen J; Guangdong Cardiovascular Institute Guangdong General Hospital Guangzhou China., Yuan Z; First Affiliated Hospital of Xi'an Jiaotong University Xi'an China., Borges JLC; Universidade Catolica de Brasilia Brasilia Brazil., Monsalvo ML; Amgen Inc. Thousand Oaks CA USA., Wang N; Amgen Inc. Thousand Oaks CA USA., Hamer AW; Amgen Inc. Thousand Oaks CA USA., Ge J; Zhongshan Hospital Fudan University Shanghai China.
Jazyk: angličtina
Zdroj: Endocrinology, diabetes & metabolism [Endocrinol Diabetes Metab] 2020 Mar 06; Vol. 3 (2), pp. e00123. Date of Electronic Publication: 2020 Mar 06 (Print Publication: 2020).
DOI: 10.1002/edm2.123
Abstrakt: Aims: We assessed the change from baseline in vitamin E, steroid hormones, adrenocorticotropic hormone (ACTH), and gonadotropins, overall and by lowest achieved low-density lipoprotein-cholesterol (LDL-C) level, in patients with type 2 diabetes and dyslipidaemia after 12 weeks of treatment with evolocumab.
Materials and Methods: This was a prespecified analysis of vitamin E, cortisol, ACTH, gonadal hormones and gonadotropins in the 12-week, placebo-controlled BERSON trial of evolocumab in patients with type 2 diabetes and dyslipidaemia. In BERSON, 981 (451 in China) patients on daily atorvastatin 20 mg were randomized to placebo or one of two doses of evolocumab. We measured analyte levels at baseline and week 12 (vitamin E in all patients; steroid/gonadal hormones only in Chinese patients).
Results: In both the global and Chinese populations, absolute vitamin E levels decreased from baseline to week 12 by approximately 6 μmol/L ( P  < .0001) among evolocumab-treated patients; however, when normalized for LDL-C, apoB or non-HDL-C, we observed no decrease in vitamin E levels. In Chinese patients, levels of cortisol and ACTH as well as the cortisol:ACTH ratio did not change significantly from baseline to week 12. No patient had a cortisol:ACTH ratio <3.0 (nmol/pmol), suggestive of adrenocortical deficiency. We did not observe clinically relevant changes for gonadal hormones and gonadotropins (oestradiol and testosterone in female and male patients, respectively, luteinizing and follicle-stimulating hormones for both).
Conclusions: In the BERSON study, evolocumab did not adversely affect vitamin E, steroid hormone or gonadotropin levels in the Chinese or global type 2 diabetic populations.ClinicalTrials.gov NCT02662569.
Competing Interests: DJB reports personal fees from Amgen South Africa, during the conduct of the study; personal fees from Sanofi‐Aventis, outside the submitted work. JC, ZY, JLB and JG report no potential conflicts of interest. AWH and MLM are employees of and stockholders in Amgen Inc NW was an employee of Amgen when the work was conducted.
(© 2020 The Authors. Endocrinology, Diabetes & Metabolism published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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