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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

1
Department of Medicine, Baylor College of Medicine, One Baylor Plaza, BCM 285, Houston, TX, 77030, USA. Electronic address: cmb@bcm.edu.
2
Department of Hypertension, Medical University of Lodz, Zeromskiego 113, 90-549, Lodz, Poland.
3
Division of Cardiology, University of British Columbia, 2775 Laurel Street 10th Floor, Vancouver, V5Z 1M9, British Columbia, Canada.
4
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.
5
Clinical Development, Esperion Therapeutics, Inc., 3891 Ranchero Dr., Ann Arbor, MI, 48108, USA.
6
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.

Abstract

BACKGROUND AND AIMS:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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

KEYWORDS:

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

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