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Randomised study of Evolocumab in Patients With Type 2 Diabetes and Dyslipidaemia on Background Statin: Pre-Specified Analysis of the China Population From the BERSON Clinical Trial.
Diabetes, Obesity & Metabolism 2019 March 10
AIM: 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 were started on background atorvastatin 20 mg/day and then were randomised 2:2:1:1 to evolocumab 140 mg every 2 weeks (Q2W) or 420 monthly (QM) or placebo Q2W or QM. Co-primary endpoints were the 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: Of 453 patients randomised 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 versus 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. This article is protected by copyright. All rights reserved.
MATERIALS AND METHODS: This is a pre-specified analysis of patients in the BERSON study (ClinicalTrials.gov, NCT02662569) in China. Patients were started on background atorvastatin 20 mg/day and then were randomised 2:2:1:1 to evolocumab 140 mg every 2 weeks (Q2W) or 420 monthly (QM) or placebo Q2W or QM. Co-primary endpoints were the 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: Of 453 patients randomised 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 versus 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. This article is protected by copyright. All rights reserved.
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