Bempedoic acid lowers LDL-C without worsening blood sugar levels
Delhi: Lipid-lowering drug bempedoic acid (Nexletol; Esperion) did not increase the incidence of type 2 diabetes (T2D) neither did it worsen blood sugar control, according to a recent study. The study found that bempedoic acid significantly lowered LDL-C and had a safety profile comparable to placebo, regardless of baseline glycemic status. Findings were presented at the virtual American Diabetes Association (ADA) 80th Scientific Sessions.
Bempedoic acid is a first-in-class drug that acts by inhibiting ATP-citrate lyase. It was approved by the Food and Drug Administration in February 2020. It is intended for patients with hypercholesterolaemia and/or at high risk of atherosclerotic cardiovascular disease (ASCVD) who need additional LDL-C lowering despite maximally-tolerated statin dose. The study was conducted to see whether Bempedoic acid had any effect on diabetes occurrence or blood sugar levels or not while controlling low density lipoprotein cholesterol.
There is interest in how lipid-lowering drugs might affect glycemia because "meta-analyses have shown about a 10% increased risk of new-onset diabetes in statin users. Lawrence A. Leiter, University of Toronto, Canada, and colleagues assessed the efficacy and safety of BA, a first-in-class ATP-citrate lyase inhibitor, by baseline glycemic status including diabetes, prediabetes, or blood sugar status in patients with hypercholesterolemia.
Four phase 3 trials randomized 3623 patients on stable lipid-lowering therapy to receive BA 180 mg or placebo (PBO) once daily for 12 to 52 weeks. Studies were grouped into 2 pools by enrollment criteria (52-weeks in patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia vs. 12- or 24- weeks in patients with statin intolerance).
The primary efficacy endpoint was percent change from baseline to week 12 in LDL-C.
Key findings of the study include:
- In both pools, BA significantly lowered LDL-C compared with PBO, regardless of baseline glycemic status.
- Significant reductions with BA vs. PBO were seen in total cholesterol, non-HDL-C, apolipoprotein B, and hsCRP.
- The safety profile of BA was similar to PBO and did not vary by glycemic status or blood sugar control.
- BA did not worsen measures of glycemic control or increase occurrence of new-onset diabetes mellitus compared with PBO.
"Bempedoic acid significantly lowered LDL-C and had a safety profile comparable to PBO, regardless of baseline glycemic status," concluded the authors.
The study, "Efficacy and Safety of Bempedoic Acid in Patients with Diabetes, Prediabetes, and Normoglycemia: Analysis of Pooled Patient-Level Data from Four Phase 3 Clinical Trials," was presented at the American Diabetes Association (ADA) 80th Scientific Sessions.