- Bempedoic acid reduces low-density lipoprotein cholesterol (LDL-C) in patients who are intolerant to statins, and it appears safe in the CLEAR Serenity phase 3 trial .
- Muscle-related adverse event rates did not differ between treatment and placebo.
Why this matters
- Statin intolerance because of symptoms related to muscle complaints remains a barrier for some patients.
- 93.3% had statin intolerance because of muscle symptoms.
- A third of these had tried 3 or more statins.
- LDL-C decreases from baseline to week 12:
- −21.4% (P<.001 treatment vs placebo.>
- Other lipid reductions also seen; also reduced high-sensitivity C-reactive protein (–24.3%; P<.001>
- Improvements persisted to week 24.
- Triglyceride, high-density lipoprotein effects were “minimal” and “negligible,” respectively.
- Treatment-emergent adverse events: 64.1% with drug vs 56.8% with placebo; most mild-moderate.
- Serious adverse events: 6.0% with drug vs 3.6% placebo.
- More discontinuations with drug vs placebo: 18.4% vs 11.7%.
- Myalgia in 4.7% with drug, 7.2% with placebo.
- Phase 3, double-blind, placebo-controlled study, 345 patients with hypercholesterolemia, statin intolerance randomly allocated 2:1 to drug (180 mg) or placebo, once daily, 24 weeks.
- Endpoint: mean percentage LDL-C change at 12 weeks.
- Funding: Esperion Therapeutics, Inc.
- Relatively short; durability evaluation is ongoing.