Adding bempedoic acid to maxed-out statins yields more LDL-C reduction

  • Goldberg AC & al.
  • JAMA
  • 12.11.2019

  • von Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • Patients with high cardiovascular disease risk who hit their maximum statin tolerance could still see decreased low-density lipoprotein cholesterol (LDL-C) with addition of bempedoic acid.
  • LDL-C dropped below 100 mg/dL in treatment group vs placebo in this 12-week trial.

Why this matters

  • These patients who hit a statins wall need other treatment options.
  • Accompanying editorial says bempedoic acid “may have a potential role in primary prevention,” too, but that costs will be a factor in its incorporation into the armamentarium preguidelines.

Key results

  • Mean baseline LDL-C was 120.4 mg/dL.
  • LDL-C at 12 weeks:
    • Bempedoic acid: 97.6 mg/dL.
    • Placebo: 122.8 mg/dL.
  • Change in 12 weeks, treatment vs placebo:
    • −15.1% vs 2.4%.
    • Difference: −17.4% (95% CI, −21.0% to −13.9%; P<.001>
  • Adverse events: 70.1% drug vs 70.8% placebo.
    • Included nasopharyngitis (5.2% vs 5.1% placebo), urinary tract infection (5.0% vs 1.9% placebo).
  • Week 24, LDL-C change from baseline:
    • –12.1% with bempedoic acid vs 2.7% placebo.
    • Difference: –14.8% (95% CI, –19.5% to –10.0%; P<.001>

Study design

  • Phase 3 randomized, placebo-controlled, double-blind trial, 91 sites in the United States and Europe, 779 patients (522 drug, 257 placebo).
  • Funding: Esperion Therapeutics Inc.

Limitations

  • Adherence to background therapy not known.
  • Not powered to detect cardiovascular outcomes.