Abstract
AimThe 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 methodsThis 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).ResultsAmong 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.ConclusionsIn 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.
Highlights
China carries the highest diabetes burden of any country worldwide,[1] with an estimated prevalence of 10.9% in 2013.2 Consistent with observations in Western populations, diabetes is a major risk factor for developing cardiovascular disease (CVD) in Chinese adults.[3]
Evolocumab significantly reduced Low-density lipoprotein cholesterol (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%) when administered with background atorvastatin
Low-density lipoprotein cholesterol (LDL-C) is the primary target in the treatment of dyslipidaemia in patients with type 2 diabetes mellitus (T2DM),[8,9,10,11] as elevated LDL-C has been associated with increased risk of CVD and cardiovascular events.[12,13,14]
Summary
China carries the highest diabetes burden of any country worldwide,[1] with an estimated prevalence of 10.9% in 2013.2 Consistent with observations in Western populations, diabetes is a major risk factor for developing cardiovascular disease (CVD) in Chinese adults.[3]. Analyses from phase 2 and 3 clinical trials have consistently shown that evolocumab, a human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduces LDL-C without adversely affecting objective measures of glycaemic control in patients with or without diabetes.[21,22,23,24,25] In the global, randomized, double-blind, 12-week phase 3 BERSON study (N = 986), in which approximately half of the patients with T2DM and hyperlipidaemia or mixed dyslipidaemia were enrolled from Chinese centres, efficacy results from the global population showed that evolocumab significantly reduced LDL-C and improved other lipid levels compared with placebo when administered in combination with background atorvastatin.[26,27] In the global population, evolocumab was safe and well tolerated, with no notable changes in glycaemic measures throughout the study. This prespecified analysis of the BERSON study was designed to investigate the efficacy and safety of evolocumab combined with background atorvastatin in patients at Chinese centres
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