Daiichi Sankyo Europe GmbH has announced the publication of results from the Phase 3 CLEAR Wisdom trial in the Journal of the American Medical Association (JAMA). Bempedoic acid is currently undergoing review for marketing authorisation by the European Medicines Agency and by the United States Food and Drug Administration.
CLEAR Wisdom, a Phase 3, double-blind, randomised trial, evaluated the efficacy, long-term safety and tolerability of bempedoic acid 180 mg versus placebo in 779 patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolaemia inadequately controlled with current lipid-modifying therapies, added on to maximally-tolerated statin therapy, which may mean no statin at all.
The JAMA publication includes results for the primary efficacy endpoint of low-density lipoprotein cholesterol (LDL-C) lowering at 12 weeks and key secondary endpoints of safety and tolerability over 52 weeks.
The publication reports that bempedoic acid:
- significantly lowered LDL-C by 17% on background maximally-tolerated statin therapy at 12 weeks, with nearly all patients (85%, 444/522 ) on moderate- or high-intensity statins, and the effect was durable through 52 weeks;
- significantly lowered high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, by 19%, and the effect was durable through 52 weeks;
- showed no worsening of haemoglobin A1c (HbA1c) (- 0.21% vs. placebo) in patients with diabetes at 12 weeks;
- showed overall adverse event rates comparable with placebo (bempedoic acid 70% 366/522 vs placebo 71% 182/257) at 52 weeks, and the proportion of patients with reported serious adverse events was similar compared with placebo (bempedoic acid 20% 106/522 vs placebo 19% 48/257) at 52 weeks;
- showed adjudicated three-component major adverse cardiac event rates of 2.7% (14/522) with bempedoic acid and 4.7% (12/257) with placebo.