Top-line results show additional LDL lowering, but outcomes data not due until 2022
Novel cholesterol-lowering agent bempedoic acid passed its final pivotal phase III trial, manufacturer Esperion announced.
Top-line results highlighted a 17% reduction in LDL with 12 weeks of bempedoic acid compared to placebo atop maximally tolerated statin treatment in the intent-to-treat analysis among patients with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia.
Inflammation was also down, with a 19% reduction in high-sensitivity C-reactive protein. In addition, patients with diabetes had hemoglobin A1c levels drop by 0.21% with the drug.
Investigators noted no "clinically relevant" safety differences between bempedoic acid and placebo over the 52-week trial. Treatment-related adverse event rates were similar between arms.
The trial randomized 779 patients 2:1 to bempedoic acid (180 mg daily) or placebo across 93 sites in North America and Europe.
"This is the final clinical study from our global, pivotal Phase 3 LDL-cholesterol lowering program for bempedoic acid. We are now one step closer to being able to provide convenient, cost-effective and complementary LDL-cholesterol lowering therapies for use by patients who require additional LDL-cholesterol lowering," said Esperion's president and chief executive officer in a statement.
Previously, Esperion had announced that bempedoic acid cut LDL by 20% in a similar phase III study and that its bempedoic acid/ezetimibe combination pill led to an LDL reduction of 32% in a 382-person phase III trial.
The company said it will file for FDA approval of bempedoic acid and the combination pill for the indication of LDL cholesterol reduction in the first quarter of 2019. This will be followed by applications to European regulators during the second quarter next year, the company said.
Whether the LDL lowering associated with bempedoic acid will actually translate into clinical benefit will be studied in the large FDA-mandated CLEAR cardiovascular outcomes trial due for completion in 2022.
Read the original article on Medpage Today: Bempedoic Acid Clears Phase III as Statin Booster