- 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.
- 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.
- 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.
- Selected patient population; generalizability unclear.