Bempedoic acid: phase 3 trial supports statin alternative

  • Laufs U & al.
  • J Am Heart Assoc
  • 2 Apr 2019

  • International Clinical Digest
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Takeaway

  • 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.

Key results

  • 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.

Study design

  • 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.

Limitations

  • Relatively short; durability evaluation is ongoing.

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