New data shows bempedoic acid lowers LDL-cholesterol without adversely impacting glycaemic control in pooled analyses of Phase 3 trials presented at the American Heart Association 2019 Scientific Sessions.
Daiichi Sankyo Europe GmbH has announced the results of two pooled analyses from four Phase 3 clinical trials of bempedoic acid which were presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia. Bempedoic acid is currently undergoing review for marketing authorisation by the European Medicines Agency (EMA) and by the United States Food and Drug Administration (FDA).
One presentation highlighted that bempedoic acid reduced haemoglobin A1c (HbA1c) by 0.19% (absolute difference) versus placebo in patients with diabetes at 12 weeks (mean change of -0.12% from 6.83% at baseline to 6.71% at week 12 in the bempedoic acid group and a mean change of 0.07% from 6.83% at baseline to 6.90% at week 12 in the placebo group). HbA1c is a standard measure of glycaemic control used in diabetes management. The analysis also showed that patients on bempedoic acid had fewer instances of new-onset diabetes as well as hyperglycaemia than those on placebo. The pooled analysis suggests that bempedoic acid does not have an adverse impact on glycaemic control in patients with and without diabetes when added to a stable background of lipid lowering therapy.
Another analysis found that across the four phase 3 studies, bempedoic acid significantly lowered low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolaemia when added on to maximally tolerated statin therapy. In patients on background statin therapy, bempedoic acid lowered LDL-C by 18% compared to placebo (absolute change of -19.8 mg/dL from 107.7 mg/dL at baseline to 87.9 mg/dL at week 12 in the bempedoic acid group, compared to an absolute change of +0.3 mg/dL from 107.5 mg/dL at baseline to 107.8 mg/dL at week 12 in the placebo group). In patients not on statin background therapy, bempedoic acid lowered LDL-C by 25% compared to placebo (absolute change of -36.5 mg/dL from 146.0 mg/dL at baseline to 109.5 mg/dL at week 12 in the bempedoic acid group, compared to an absolute change of +0.6 mg/dL from 141.2 mg/dL at baseline to 141.8 mg/dL at week 12 in the placebo group).
Bempedoic acid is being developed as a cost-effective, convenient, once-daily, oral add-on treatment for people with hypercholesterolaemia who are unable to reach LDL-C goals after optimised oral lipid lowering therapies and remain at high risk of a cardiovascular event such as a heart attack or stroke.