According to study results published in Diabetes, Obesity and Metabolism, 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.
The BERSON 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 co-primary endpoints 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 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. The incidence of diabetic adverse events was higher with evolocumab compared with placebo. There were no differences over time between evolocumab and placebo in measures of glycemic control.
Evolocumab is a fully human monoclonal antibody. It was approved by the U.S. FDA in 2015 for cardiovascular disease and as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with hypercholesterolemia. Evolocumab is manufactured by Amgen and is marketed as Repatha.