Evolocumab significantly reduced low-density lipoprotein cholesterol (LDL-C) in individuals with type 2 diabetes (T2D) on maximally tolerated statin therapy without major adverse effects, according to a study published in Diabetologia.
The researchers of the evolocumab efficacy and safety in T2D on background statin therapy (BANTING) study investigated the efficacy and safety of evolocumab in individuals with T2D currently on a maximally tolerated dose of a statin of at least moderate intensity, who had high LDL-C or non-high-density lipoprotein cholesterol (non-HDL-C) levels.
The study was primarily aimed at assessing the effect of evolocumab 420 mg administered every 4 weeks for 12 weeks on the percentage change in LDL-C among individuals with T2D and hypercholesterolemia or mixed dyslipidemia, compared with placebo treatment. The investigators also studied changes in LDL-C from baseline and the percentage change in non-HDL-C, apolipoprotein B, total cholesterol, lipoprotein(a), triacylglycerol (triglycerides), HDL-C, and very low-density lipoprotein cholesterol.
The percentage of participants achieving LDL-C less than 1.81 mmol/l and the percentage of participants achieving a 50% or greater reduction in LDL-C from baseline were also taken into account along with safety and tolerability of the evolocumab.
A total of 421 participants were randomly assigned at a ratio of 2:1 to evolocumab (n=280) or placebo (n=141). The mean age of the participants was approximately 62 years, and a majority of the participants were white (77%). Women comprised 42.9% of the participants taking evolocumab and 46.1% of those taking placebo. Eligible participants were aged 18 or older with T2D and had glycated hemoglobin less than 10% (86 mmol/mol).
The primary results from the BANTING study show that evolocumab treatment decreased the LDL-C by 54% to 65% and non-HDL-cholesterol by 47% to 57%. Evolocumab also improved the levels of other lipids, and many of the participants who received evolocumab achieved a 50% or greater reduction. The results of the study also indicate that evolocumab treatment also resulted in desirable changes (P <.05) in postprandial levels of chylomicrons, very low-density lipoprotein cholesterol, and LDL-C. Additionally, the researchers did not find any adverse effects that were related to evolocumab treatment.
One of the major limitations of the study is the shorter duration of follow-up (12 weeks), which did not allow the evaluation of long-term safety and durability of the treatment response.
The investigators suggested that the BANTING study with placebo-controlled data provides additional evidence about the efficacy and safety of the evolocumab therapy in individuals with T2D and hypercholesterolemia or mixed dyslipidemia and on a maximum tolerated statin of at least moderate intensity.
This study was supported by Amgen, Inc. Please see original reference for a complete list of authors’ disclosures.
Rosenson RS, Daviglus ML, Handelsman Y, et al. Efficacy and safety of evolocumab in individuals with type 2 diabetes mellitus: primary results of the randomised controlled BANTING study [published online April 5, 2019]. Diabetologia. doi: 10.1007/s00125-019-4856-7