6/28/23, 12:11 AM CLEAR Outcomes Pathway Feedback Search Clinical Topics Home Studies CLEAR Outcomes CLEAR Outcomes Disease Disease Disease Coronary artery disease Dyslipidemia Familia Trial question What is the role of bempedoic acid in patients with statin-intolerant patients? Study design Multi-center Double blinded RCT Population Characteristics of study participants 48.0% female N = 13970 52.0% male 13970 patients (6740 female, 7230 male) Inclusion criteria: patients who were unable or unwilling to take statins owing to unacceptable adverse effects and had or were at high risk for CVD Key exclusion criteria: fasting blood triglycerides > 500 mg/dL; recent history of major cardiovascular events, TIA, or unstable or symptomatic cardiac arrhythmia; history of severe HF; uncontrolled hypertension or uncontrolled diabetes Interventions N=6992 bempedoic acid (an oral dose of 180 mg daily) N=6978 placebo (matching placebo) Primary outcome Major adverse cardiovascular events 13.3 % 13.3 11.7 10 0 % https://web.pathway.md/studies/recrX8Cn3Yxp3ECUX 1/2 6/28/23, 12:11 AM 10.0 % CLEAR Outcomes Pathway 6.7 % Significant decrease 3.3 % NNT = 62 0.0 % Bempedoic acid Placebo Significant decrease in major adverse cardiovascular events (11.7% vs. 13.3%; HR 0.87, 95% CI 0.79 to 0.96) Secondary outcomes Significant decrease in composite of death from cardiovascular causes, nonfatal stroke, or nonfatal myocardial infarction (8.2% vs. 9.5%; HR 0.85, 95% CI 0.76 to 0.96) Significant decrease in fatal or nonfatal myocardial infarction (3.7% vs. 4.8%; HR 0.77, 95% CI 0.66 to 0.91) Significant decrease in coronary revascularization (6.2% vs. 7.6%; HR 0.81, 95% CI 0.72 to 0.92) Safety outcomes No significant difference in adverse and serious adverse events. Significant difference in hyperuricemia (10.9% vs. 5.6%). Conclusion In patients who were unable or unwilling to take statins owing to unacceptable adverse effects and had or were at high risk for CVD, bempedoic acid was superior to placebo with respect to major adverse cardiovascular events. Reference Steven E Nissen, A Michael Lincoff, Danielle Brennan et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. 2023 Apr 13;388(15):1353-1364. Open reference URL https://web.pathway.md/studies/recrX8Cn3Yxp3ECUX 2/2