medwireNews: The potent lipid-lowering effects of the PCSK9 inhibitor evolocumab have been demonstrated in a randomized trial conducted specifically in people with type 2 diabetes.
The cardioprotective effect of evolocumab has already been shown in a prespecified analysis of the 40% of the FOURIER cohort that had type 2 diabetes. The BANTING trial tested the lipid-lowering efficacy in 421 people who all had type 2 diabetes plus hypercholesterolemia or mixed dyslipidemia at baseline, and were already taking a statin.
Over the course of 12 weeks of receiving monthly subcutaneous injections, low-density lipoprotein (LDL) cholesterol levels fell by an average of 54.3% in the 280 people receiving evolocumab 420 mg, compared with 1.1% in the 141 who were given placebo injections. In all, 84.5% of people given evolocumab achieved a level below the target of 1.81 mmol/L versus 15.4% of those who took placebo.
Levels of non-high-density lipoprotein cholesterol, which the researchers say predicts atherosclerotic events more strongly than LDL cholesterol does in people with type 2 diabetes, fell by an average of 46.9% versus 0.6%.
Triglycerides fell by an average of 8.9% in the evolocumab group, versus a 4.8% increase with placebo, and apolipoprotein B levels by 40.3% versus a 1.8% rise. Glycemic measures were unaffected.
Robert Rosenson (Icahn School of Medicine at Mount Sinai, New York, USA) and co-researchers note in Diabetologia that evolocumab was well tolerated, but caution that the short follow-up “limited the ability to assess long-term safety and durability of response.”
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group