• Bempedoic Acid Clears Phase III as Statin Booster

    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.

    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.

    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.

    Source:

    Read the original article on Medpage Today: Bempedoic Acid Clears Phase III as Statin Booster

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