Efficacy and safety of bempedoic acid in patients not receiving statins in phase 3 clinical trials

Ulrich Laufs, Christie M. Ballantyne, Maciej Banach, Harold Bays, Alberico L. Catapano, P. Barton Duell, Anne C. Goldberg, Antonio M. Gotto, Lawrence A. Leiter, Kausik K. Ray, Le Anne T. Bloedon, Diane MacDougall, Yang Zhang, G. B.John Mancini

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Despite the high incidence of patients with statin tolerance problems, randomized evaluations of nonstatin oral treatment options for lowering of low-density lipoprotein cholesterol (LDL-C) in this population are sparse. Objective: To assess the LDL-C lowering effect of bempedoic acid in patients not taking statins. Methods: This was a pooled analysis of data from patients enrolled in four phase 3 bempedoic acid studies (12 to 52 weeks in duration) who were not taking concomitant statins (Phase 3 No Statin Cohort) and a phase 3 bempedoic acid plus ezetimibe fixed-dose combination study (BA+EZE FDC No Statin Cohort). The primary endpoint for all studies was the percent change from baseline to week 12 in LDL-C levels. Safety and tolerability were assessed by laboratory values and adverse events. Results: In the Phase 3 No Statin Cohort, bempedoic acid (n = 394) lowered LDL-C levels at week 12 significantly more than placebo (n = 192; −26.5% [95% CI, −29.7%, −23.2%]; P<0.001). The fixed-dose combination of bempedoic acid with ezetimibe lowered LDL-C by 39.2% (95% CI, −51.7% to −26.7%; P<0.001). Muscle-related disorders occurred at a rate of 26.4 and 28.6 per 100 person-years with bempedoic acid and placebo, respectively. Conclusions: In patients with hypercholesterolemia unable to take statins, bempedoic acid lowered LDL-C levels by a mean of 26.5% vs placebo and bempedoic acid + ezetimibe fixed-dose combination lowered LDL-C by 39.2%. The treatments were generally well tolerated, suggesting that bempedoic acid may be efficacious and well tolerated in this challenging-to-treat patient population.

Original languageEnglish (US)
JournalJournal of Clinical Lipidology
DOIs
StateAccepted/In press - 2022

Keywords

  • Bempedoic acid
  • Ezetimibe
  • Low-density lipoprotein cholesterol
  • Statin
  • Statin intolerance
  • Statin-associated muscle symptoms (SAMS)

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics
  • Cardiology and Cardiovascular Medicine

Fingerprint

Dive into the research topics of 'Efficacy and safety of bempedoic acid in patients not receiving statins in phase 3 clinical trials'. Together they form a unique fingerprint.

Cite this