Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre-specified analysis of the Chinese population from the BERSON clinical trial
Diabetes, Obesity and Metabolism Apr 19, 2019
Chen Y, et al. - In a cohort of Chinese patients with type 2 diabetes mellitus (T2DM) and hyperlipidemia or mixed dyslipidemia, researchers tested the safety and effectiveness of evolocumab with background atorvastatin. Patients started 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. Of 453 randomized patients, 451 received at ≥ 1 dose (evolocumab or placebo) of the study drug. With evolocumab vs placebo, non-HDL-C, ApoB100, total cholesterol, Lp(a), triglycerides, HDL-C, and VLDL-C improved significantly. No new safety findings with evolocumab were observed. Compared with placebo, the incidence of diabetes adverse events was higher with evolocumab. Over time, there were no differences in glycemic control measures between evolocumab and placebo. According to findings, evolocumab significantly reduced LDL-C and other atherogenic lipids in patients with T2DM and hyperlipidemia or mixed dyslipidemia receiving background atorvastatin. Overall, they concluded that evolocumab was safe and well tolerated, with no impact on glycemic control measures.
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