Send to

Choose Destination

See 1 citation found by title matching your search:

Atherosclerosis. 2018 Oct;277:195-203. doi: 10.1016/j.atherosclerosis.2018.06.002. Epub 2018 Jun 12.

Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study.

Author information

Department of Medicine, Baylor College of Medicine, One Baylor Plaza, BCM 285, Houston, TX, 77030, USA. Electronic address:
Department of Hypertension, Medical University of Lodz, Zeromskiego 113, 90-549, Lodz, Poland.
Division of Cardiology, University of British Columbia, 2775 Laurel Street 10th Floor, Vancouver, V5Z 1M9, British Columbia, Canada.
David Geffen School of Medicine at UCLA and Cedars-Sinai Medical Center, Los Angeles, CA, USA; Westside Medical Associates of Los Angeles, 99 La Cienega Blvd. #203, Beverly Hills, CA, 90211, USA.
Clinical Development, Esperion Therapeutics, Inc., 3891 Ranchero Dr., Ann Arbor, MI, 48108, USA.
Division of Endocrinology & Metabolism, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, 61 Queen St East #6121, Toronto, M5C 2T2, Ontario, Canada.



Patients with hyperlipidemia who are unable to tolerate optimal statin therapy are at increased cardiovascular risk due to ongoing elevations in low-density lipoprotein cholesterol (LDL-C). The objective of CLEAR Tranquility (NCT03001076) was to evaluate the efficacy and safety of bempedoic acid when added to background lipid-modifying therapy in patients with a history of statin intolerance who require additional LDL-C lowering.


This phase 3, multicenter, randomized, double-blind, placebo-controlled study enrolled patients with a history of statin intolerance and an LDL-C ≥100 mg/dL while on stable lipid-modifying therapy. After a 4-week ezetimibe 10 mg/day run-in period, patients were randomized 2:1 to treatment with bempedoic acid 180 mg or placebo once daily added to ezetimibe 10 mg/day for 12 weeks. The primary endpoint was the percent change from baseline to week 12 in LDL-C.


The study population comprised 269 patients (181 bempedoic acid, 88 placebo). Bempedoic acid added to background lipid-modifying therapy that included ezetimibe reduced LDL-C by 28.5% more than placebo (p < 0.001; -23.5% bempedoic acid, +5.0% placebo). Significant reductions in secondary endpoints, including non-high-density lipoprotein cholesterol (-23.6%), total cholesterol (-18.0%), apolipoprotein B (-19.3%), and high-sensitivity C-reactive protein (-31.0%), were observed with bempedoic acid vs. placebo (p < 0.001). Bempedoic acid was well tolerated; rates of treatment-emergent adverse events, muscle-related adverse events, and discontinuations were similar in the bempedoic acid and placebo treatment groups.


Bempedoic acid may provide an oral therapeutic option complementary to ezetimibe in statin intolerant patients who require additional LDL-C lowering.


Cardiovascular disease; ETC-1002; Hyperlipidemia; Low-density lipoprotein cholesterol; Prevention; Statin intolerance; Statin-associated muscle symptoms

Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center