Steve Nissen, MD: Design and Clinical Implications of CLEAR Outcomes

The excitement surrounding the release of results from CLEAR Outcomes at the American College of Cardiology 2023 Annual Scientific Session Together With the World Congress of Cardiology was evidenced by the capacity crowd attending the official presentation.

Presented by Steve Nissen, MD, chief academic officer of the Heart Vascular & Thoracic Institute at Cleveland Clinic and chair of the study, results of the trial indicated use of bempedoic acid was associated with a statistically significant reduction in the primary endpoint of 4-point major adverse cardiovascular events relative to placebo therapy (Hazard ratio [HR], 0.87 [95% confidence interval [CI], 0.79-0.96]; P=.004), with additional analysis indicating use was also associated with a reduction in fatal or nonfatal myocardial infarction (HR, 0.77 [95% CI, 0.66-0.91]; P=.002) and coronary revascularization (HR, 0.81 [95% CI, 0.72-0.92]; P=.001).¹

When examining safety of the agent, results demonstrated there were no statistically significant reductions were observed for cardiovascular mortality (HR, 1.04 [95% CI, 0.88-1.24]) or all-cause mortality (HR, 1.03 [95% CI, 0.90-1.18]). Further safety analyses indicated incidences of both gout (3.1% vs 2.1%) and cholelithiasis (2.2% vs 1.2%) were greater in the bempedoic acid arm than the placebo arm.¹

Among several noteworthy aspects of the trial design for CLEAR Outcomes was method of determining statin intolerance among participants. As part of the trial, participants were required to have a documented intolerance to at least 2 different statins and sign a confirmation letter declaring they were both aware of the benefits of statin therapy and intolerant to maximally tolerated statins.

With an interest in learning more about the trial, its design, and the applicability of results to clinical practice, HCPLive sat down with Nissen following presentation of study results. That conversation is the subject of the video found below.

References:

1. Nissen SE, Lincoff AM, Brennan D, et al. Bempedoic acid and cardiovascular outcomes in statin-intolerant patients. N Engl J Med. DOI: 10.1056/NEJMoa2215024.

Nissen reports having received grants or research funding from Esperion Therapeutics, Abbvie, Amgen, AstraZeneca, AstraZeneca Pharmaceuticals, Bristol-Myers Squibb Company, and others. Here is a link to his full list of disclosures.