Search

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. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to evaluate the efficacy and safety of evolocumab with background atorvastatin in Chinese patients with type 2 diabetes mellitus (T2DM) and hyperlipidaemia or mixed dyslipidaemia. Materials and methods: This is a pre‐specified analysis of patients in the BERSON study (ClinicalTrials.gov, NCT02662569) in China. Patients initiated background atorvastatin 20 mg/d, after which they were randomized 2:2:1:1 to evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) or to placebo Q2W or QM. Co‐primary endpoints were percentage change in LDL cholesterol (LDL‐C) from baseline to week 12 and from baseline to the mean of weeks 10 and 12. Additional endpoints included atherogenic lipids, glycaemic measures and adverse events (AEs). Results: Among 453 patients randomized in China, 451 received at least one dose of study drug (evolocumab or placebo). Evolocumab significantly reduced LDL‐C compared with placebo at week 12 (Q2W, −85.0%; QM, −74.8%) and at the mean of weeks 10 and 12 (Q2W, −80.4%; QM, −81.0%) (adjusted P < 0.0001 for all) when administered with background atorvastatin. Non‐HDL‐C, ApoB100, total cholesterol, Lp(a), triglycerides, HDL‐C and VLDL‐C significantly improved with evolocumab vs placebo. No new safety findings were observed with evolocumab. The incidence of diabetes AEs was higher with evolocumab compared with placebo. There were no differences over time between evolocumab and placebo in measures of glycaemic control. Conclusions: In patients in China with T2DM and hyperlipidaemia or mixed dyslipidaemia receiving background atorvastatin, evolocumab significantly reduced LDL‐C and other atherogenic lipids, was well tolerated, and had no notable impact on glycaemic measures. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the lipid‐lowering efficacy and safety of evolocumab combined with background atorvastatin in patients with type 2 diabetes mellitus (T2DM) and hyperlipidaemia or mixed dyslipidaemia. Materials and methods: BERSON was a double‐blind, 12‐week, phase 3 study (NCT02662569) conducted in 10 countries. Patients ≥18 to ≤80 years with type T2DM received atorvastatin 20 mg/d and were randomised 2:2:1:1 to evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) or placebo Q2W or QM. Co‐primary endpoints were the percentage change in low‐density lipoprotein cholesterol (LDL‐C) from baseline to week 12 and from baseline to the mean of weeks 10 and 12. Additional endpoints included atherogenic lipids, glycaemic measures, and adverse events (AEs). Results: Overall, 981 patients were randomised and received ≥1 dose of study drug. Evolocumab significantly reduced LDL‐C versus placebo at week 12 (Q2W, −71.8%; QM, −74.9%) and at the mean of weeks 10 and 12 (Q2W, −70.3%; QM, −70.0%; adjusted P < 0.0001 for all) when administered with atorvastatin. Non‐high‐density lipoprotein cholesterol, apolipoprotein B100, total cholesterol, lipoprotein (a), triglycerides, high‐density lipoprotein cholesterol, and very low‐density lipoprotein cholesterol improved significantly with evolocumab versus placebo. The overall incidence of AEs was similar between evolocumab and placebo‐treated patients, and there were no clinically meaningful differences in changes over time in glycaemic variables (fasting serum glucose and HbA1c) between the two groups. Conclusions: In patients with T2DM and hyperlipidaemia or mixed dyslipidaemia on statin, evolocumab significantly reduced LDL‐C and other atherogenic lipids, was well tolerated, and had no notable impact on glycaemic measures. [ABSTRACT FROM AUTHOR]