LDL: bempedoic acid added to max statin yields steeper drops

  • N Engl J Med

  • International Clinical Digest
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Takeaway

  • In this 52-week trial, bempedoic acid added to maximally tolerated statin dose led to steeper low-density lipoprotein cholesterol (LDL) reductions vs added placebo.
  • Adverse event rates were similar to placebo group in the CLEAR Harmony trial .

Why this matters

  • This enzyme inhibitor has shown efficacy potential in previous studies, but long-term safety, efficacy data are lacking.

Key results

  • Mean baseline LDL: 103.2±29.4 mg/dL.
  • Week 12, mean LDL decrease:
    • 18.1 percentage points more than placebo (95% CI, –20.0 to –16.1; P<.001>
  • Week 24:
    • −16.1 percentage points vs placebo (95% CI, –18.2 to –14.0; P<.001>
  • Other markers, including total and non-LDL cholesterol, also decreased more with bempedoic acid.
  • Effects lasted through week 52.
  • Adverse event incidence (most mild-moderate):
    • 78.5%, bempedoic acid.
    • 78.7%, placebo.
  • Serious adverse events:
    • 14.5%, bempedoic acid.
    • 14.0%, placebo.
  • Discontinuation rate because of adverse events was higher with bempedoic acid, without significant event differences.
  • Gout was more common with bempedoic acid: 1.2% vs 0.3% placebo.
  • Deaths (cancer, cardiovascular disease) judged to be unrelated to intervention.

Study design

  • Randomized controlled trial (RCT), 2230 patients (bempedoic acid:placebo, 2:1) with atherosclerotic cardiovascular disease, familial hypercholesterolemia, or both on maximally tolerated statin.
  • Endpoints: safety, efficacy.
  • Funding: Esperion Therapeutics.

Limitations

  • Selected patient population; generalizability unclear.

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