Bempedoic Acid Phase III Trial Meets Primary Endpoint for Cutting LDL Cholesterol
The first-in-class, once-daily pill could be a convenient option for patients needing additional lipid-lowering on top of other oral drugs.
Compared with placebo, bempedoic acid 180 mg reduces LDL cholesterol by 28% in patients with atherosclerotic cardiovascular disease inadequately treated with ezetimibe 10 mg and low-dose statins, according to top-line, phase III data released this week testing the novel oral drug.
Esperion, the drug’s manufacturer, announced that their 12-week study met its primary endpoint by lowering LDL-cholesterol by 23% from baseline using the first-in-class agent, whereas the placebo group saw a 5% increase (P < 0.001). Treated patients also experienced a 33% reduction in high-sensitivity C-reactive protein compared with a 2% increase in the placebo arm (P < 0.001).
“These results suggest that bempedoic acid, with its targeted mechanism of action and convenient, oral, once-daily administration, could be an important new treatment option for a wide range of patients, including those unable to tolerate moderate or high doses of commonly-used statin therapy,” said Esperion’s phase III executive committee chair Christie M. Ballantyne, MD (Baylor College of Medicine, Houston, TX), in the press release.
Full trial results are expected to be released at a major meeting later this year.
Esperion. Esperion announces positive top-line results from first pivotal phase 3 study of bempedoic acid. Published and accessed on: March 7, 2018.