Dr. Tomasz Jurga discusses the CLEAR Outcomes trial and current cholesterol management considerations with co-host, Dr. Liz Wang.
0:00-2:19: Introduction
2:20-7:13: TIME trial overview
7:14-11:18: What is bempedoic acid?
11:19-16:45: What is the current landscape of cholesterol management?
16:46-20:54: Previous CLEAR trials: Tranquility, Serenity, Harmony, Wisdom
20:55-28:55: CLEAR Outcomes overall thoughts
28:56-32:38: Where does bempedoic acid fit into therapy?
32:39-36:27: Approach to statin intolerance
36:28-40:09: Overall approach to reduce ASCVD
40:10-42:58: Closing thoughts
References:
CLEAR Outcomes
Nissen SE, Lincoff AM, Brennan D, et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. 2023;388(15):1353-1364. doi:10.1056/NEJMoa2215024
CLEAR Tranquility
Ballantyne CM, Banach M, Mancini GBJ, et al. Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study. Atherosclerosis. 2018;277:195-203. doi:10.1016/j.atherosclerosis.2018.06.002
CLEAR Harmony
Ray KK, Bays HE, Catapano AL, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019;380(11):1022-1032. doi:10.1056/NEJMoa1803917
CLEAR Serenity
Laufs U, Banach M, Mancini GBJ, et al. Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019;8(7):e011662. doi:10.1161/JAHA.118.011662
CLEAR Wisdom
Goldberg AC, Leiter LA, Stroes ESG, et al. Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial. JAMA. 2019;322(18):1780-1788. doi:10.1001/jama.2019.16585
Pooled meta-analysis of four CLEAR trials:
Banach M, Duell PB, Gotto AM Jr, et al. Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia. JAMA Cardiol. 2020;5(10):1124-1135. doi:10.1001/jamacardio.2020.2314
Subanalysis of CLEAR outcomes primary prevention participants:
Nissen SE, Menon V, Nicholls SJ, et al. Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients. JAMA. 2023;330(2):131-140. doi:10.1001/jama.2023.9696
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