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