- In an analysis of 4 phase 3 trials, bempedoic acid did not worsen glycemic control or increase the occurrence of new-onset diabetes mellitus vs placebo.
- It significantly lowered low-density lipoprotein (LDL)-cholesterol regardless of glycemic status.
Why this matters
- Current guidelines support aggressive LDL-cholesterol lowering in patients with diabetes.
- Pooled data analysis from 4 phase 3 trials in 3623 patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia randomly assigned 2:1 to bempedoic acid 180 mg/day or placebo.
- Primary efficacy endpoint: percent change from baseline to week 12 in LDL-C.
- Funding: Esperion Therapeutics, Inc.
- 52% of patients had prediabetes and 31% had diabetes.
- Significant reduction in LDL-C (least squares mean differences; P<.001 for all was observed at weeks with bempedoic acid in:>
- patients receiving statins
- diabetes: −19.2%
- prediabetes: −18.5%
- normoglycemic: −17.2%
- statin intolerant patients
- diabetes: −18.9%
- prediabetes: −29.7%
- normoglycemic: −23.6%
The lead author Lawrence A. Leiter MD, from the University of Toronto, Ontario, Canada said, "The current study is important as it shows overall consistent efficacy and safety regardless of glycemic status and no increase in new-onset diabetes and bempedoic acid will be a useful add-on to any patient who requires additional LDL-cholesterol lowering."