Compared with placebo, the addition of monthly evolocumab to statin therapy for individuals with hypercholesterolemia or mixed dyslipidemia and type 2 diabetes (T2D) led to low-density lipoprotein cholesterol (LDL-C) reductions up to 64.1%, according to study results published in Diabetologia.
This placebo-controlled, randomized outpatient study was designed to determine the efficacy of 12 weeks of monthly evolocumab vs 12 weeks of placebo in lowering LDL-C in individuals with both T2D and hypercholesterolemia or mixed dyslipidemia receiving a maximum-tolerated statin dose of at least moderate intensity. Eligible participants were aged ≥18 years, had a glycated hemoglobin level <10% (86 mmol/mol), and had been receiving pharmacologic diabetes therapy for ≥6 months. Participants were randomly assigned to evolocumab 420 mg or placebo 2:1. Treatment assignment was blinded to investigators, sponsor study team, site staff, and participants.
Of 421 participants, 280 received evolocumab and 141 received placebo. Participants receiving evolocumab showed a 54.3% ± 1.4% reduction in LDL-C at week 12 compared with a 1.1% ± 1.9% reduction with placebo (P <.0001). Patients in the evolocumab group had a mean reduction at weeks 10 and 12 of 65% ± 1.3% compared with a 0.8% ± 1.8% reduction with placebo (P <.0001). There was also a 46.9% ± 1.3% reduction of non-high-density lipoprotein cholesterol at week 12 compared with a 0.6% ± 1.8% reduction with placebo; for the mean of weeks 10 and 12, patients receiving evolocumab showed a 56.6% ± 1.2% reduction vs a 0.1% ± 1.6% reduction with placebo.
Treatment with evolocumab allowed 92.7% of individuals to achieve LDL-C levels <1.81 mmol/L. At week 12, after a 120-minute mixed-meal tolerance test, favorable changes were seen in chylomicron cholesterol, chylomicron triacylglycerol (triglycerides), very LDL-C, and LDL-C (P <.05; no multiplicity adjustment) in patients who received evolocumab.
Treatment with evolocumab had no notable effect on glycemic variables and was well tolerated.
Study investigators concluded that these findings support the safety and efficacy of monthly evolocumab for patients with T2D and hypercholesterolemia or mixed dyslipidemia receiving statin therapy.
This study was funded by Amgen Inc and several authors disclosed associations with the pharmaceutical industry. Please see the original reference for a full 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