Treatment with evolocumab significantly reduced low-density lipoprotein cholesterol (LDL-C) and other atherogenic lipid levels but had no notable impact on glycemic measures in Chinese patients with type 2 diabetes and hyperlipidemia or mixed dyslipidemia, according to study findings published in Diabetes, Obesity and Metabolism.
Previous studies have shown that the human monoclonal antibody evolocumab significantly reduces LDL-C without affecting objective measures of glycemic control adversely in patients both with and without diabetes. The current study evaluated the efficacy and safety of evolocumab with background atorvastatin in 453 patients who were randomly assigned to receive background atorvastatin (20 mg/day) plus subcutaneous evolocumab 140 mg every 2 weeks, evolocumab 420 mg every month, placebo every 2 weeks, or placebo every month. The coprimary end points were the percentage change in LDL-C from baseline to week 12 and from baseline to the mean of weeks 10 and 12.
The results showed that at week 12, evolocumab significantly reduced LDL-C vs placebo (every 2 weeks, -85.0%; monthly, -74.8%). LDL-C concentrations were reduced to <70 mg/dL (1.8 mmol/L) in 96.4% and 95.1% of patients in the groups receiving evolocumab every 2 weeks and monthly, respectively, at week 12 and in 97.2% and 95.3% at the mean of weeks 10 and 12. Non-high-density lipoprotein cholesterol, apolipoprotein B100, total cholesterol, lipoprotein(a), triglycerides, high-density lipoprotein cholesterol, and very low-density lipoprotein cholesterol levels also showed significant improvement with evolocumab compared with placebo.
“Although this study was limited to a 12-week follow-up, the efficacy and safety results are consistent with those of prior prespecified and post hoc analyses of evolocumab in patients with [type 2 diabetes] that have a larger sample size and/or longer duration,” wrote the researchers.
This study was funded by Amgen Inc, which markets subcutaneous evolocumab.
Chen Y, Yuan Z, Lu J, et al. 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 [published online March 9, 2019]. Diabetes Obes Metab. doi:10.1111/dom.13700