6/28/23, 12:11 AM CLEAR Harmony Pathway Feedback Search Clinical Topics Home Studies CLEAR Harmony CLEAR Harmony Disease Disease Disease Coronary artery disease Dyslipidemia Familia Trial question What is the role of bempedoic acid in patients with increased LDL cholesterol levels? Study design Multi-center Double blinded RCT Population Characteristics of study participants 27.0% female N = 2230 73.0% male 2230 patients (602 female, 1628 male) Inclusion criteria: patients taking the maximum tolerated dose of statin therapy with ASCVD Key exclusion criteria: use of gemfibrozil or simvastatin at doses > 40 mg/day; total fasting triglyceride 500 mg/dL; BMI 50 kg/m ; use of a proprotein convertase subtilisin/kexin 9 within the past 4 weeks Interventions N=1488 bempedoic acid (at an oral dose of 180 mg once daily) N=742 placebo (matching placebo tablet taken PO once daily) Primary outcome Adverse events 78.7 % 78.5 78.7 59.0 % https://web.pathway.md/studies/recFQneg6S8gUMIdX 1/2 6/28/23, 12:11 AM CLEAR Harmony Pathway 39.4 % 19.7 % No significant difference 0.0 % Bempedoic acid Placebo No significant difference in adverse events (78.5% vs. 78.7%; ARD -0.2, 95% CI -3.39 to 2.99) Secondary outcomes Significant decrease in change in the low-density lipoprotein cholesterol level at week 12 (-16.5% vs. 1.6%; ARD -18.1, 95% CI -20 to -16.1) Significant decrease in change in the low-density lipoprotein cholesterol level at week 24 (-14.9% vs. 1.2%; ARD -16.1, 95% CI -18.2 to -14) Significant decrease in total cholesterol level elevation at week 12 (-10.3% vs. 0.8%; ARD -11.1, 95% CI -12.5 to -9.8) Safety outcomes No significant difference in serious adverse events. Significant differences in adverse events leading to discontinuation of trial agent (10.9% vs. 7.1%), gout (1.2% vs. 0.3%), new-onset or worsening diabetes (3.3% vs. 5.4%). Conclusion In patients taking the maximum tolerated dose of statin therapy with ASCVD, bempedoic acid was not superior to placebo with respect to adverse events. Reference Kausik K Ray, Harold E Bays, Alberico L Catapano et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019 Mar 14;380(11):1022-1032. Open reference URL https://web.pathway.md/studies/recFQneg6S8gUMIdX 2/2