In order to bring you the best possible user experience, this site uses Javascript. If you are seeing this message, it is likely that the Javascript option in your browser is disabled. For optimal viewing of this site, please ensure that Javascript is enabled for your browser.

The free consultation period for this content is over.

It is now only available year-round to ESC Professional Members, Fellows of the ESC, and Young combined Members

Safety profile of bempedoic acid: pooled analysis of 4 phase 3 clinical trials

Session Poster Session 6

Speaker Christie Ballantyne

Event : ESC Congress 2019

  • Topic : cardiovascular pharmacology
  • Sub-topic : Lipid-Lowering Agents
  • Session type : Poster Session

Authors : C M Ballantyne (Houston,US), M Banach (Lodz,PL), A L Catapano (Milan,IT), P B Duell (Portland,US), U Laufs (Leipzig,DE), L A Leiter (Toronto,CA), G B J Mancini (Vancouver,CA), K K Ray (London,GB), L T Bloedon (Ann Arbor,US), W J Sasiela (Ann Arbor,US), Z Ye (Ann Arbor,US), H E Bays (Louisville,US)

C M Ballantyne1 , M Banach2 , A L Catapano3 , P B Duell4 , U Laufs5 , L A Leiter6 , G B J Mancini7 , K K Ray8 , L T Bloedon9 , W J Sasiela9 , Z Ye9 , H E Bays10 , 1Baylor College of Medicine - Houston - United States of America , 2Medical University of Lodz - Lodz - Poland , 3University of Milan - Milan - Italy , 4Oregon Health Sciences University - Portland - United States of America , 5Leipzig University - Leipzig - Germany , 6St. Michael’s Hospital, University of Toronto - Toronto - Canada , 7University of British Columbia - Vancouver - Canada , 8Imperial College London - London - United Kingdom of Great Britain & Northern Ireland , 9Esperion Therapeutics, Inc. - Ann Arbor - United States of America , 10Louisville Metabolic and Atherosclerosis Research Center - Louisville - United States of America ,


Background/Introduction: Bempedoic acid (BA), an oral, first-in-class, ATP-citrate lyase inhibitor, lowers low-density lipoprotein cholesterol (LDL-C) in patients who do not achieve sufficient lipid lowering with guideline-recommended first-line therapies.

Purpose: We evaluated the safety profile of BA in phase 3 trials.

Methods: Data were pooled from 4 randomised, double-blind, placebo-controlled studies that enrolled patients with hyperlipidaemia who were receiving stable lipid-lowering therapy (LLT; maximally tolerated statins +/- nonstatin therapies) and required additional LDL-C lowering. Patients were randomised (2:1) to BA 180 mg or placebo daily for 12 to 52 weeks.

Results: Median exposure for 3621 patients (2424 BA, 1197 placebo) was 363 days. Background LLT included a statin +/- other LLT (83.8%), nonstatin LLT alone (9.4%), or none (6.8%). Adverse event (AE) and serious AE rates were similar between groups (Table). The most common AEs in the BA and placebo groups were nasopharyngitis (7.4% vs 8.9%), myalgia (4.9% vs 5.3%), and urinary tract infection (4.5% vs 5.5%). Rates of new-onset/worsening diabetes were 4.0% for BA and 5.6% for placebo. No AEs leading to discontinuation differed by =0.5% between treatments. All fatal AEs were judged by the investigator as unrelated to treatment. A trend was observed for a lower 3-component major adverse cardiac event rate with BA vs placebo (hazard ratio, 0.85; 95% confidence interval: 0.53 to 1.37). Changes in uric acid, creatinine, and haemoglobin were apparent at week 4, stable over time, and reversible after stopping BA. Gout occurred in 1.4% and 0.4% of patients in the BA and placebo groups, respectively. The safety profile of BA was consistent across background therapies, demographics, and disease characteristics.

Conclusion(s): BA added to LLT was well tolerated, with a safety profile comparable to placebo.

Placebo (n=1197)

BA (n=2424)

Any AE / SAE, % (n)

72.5 (868) / 13.3 (159)

73.1 (1171) / 14.1 (341)

Drug discontinuation due to an AE, % (n)

7.8 (93)

11.3 (273)

AE with a fatal outcome, % (n)

0.3 (4)

0.8 (19)

Aminotransferase elevation >3 x ULN, % (n)

0.3 (3)

0.7 (18)

Aminotransferase elevation >5 x ULN, % (n)

0.2 (2)

0.2 (6)

Creatine kinase elevation > 5 x ULN, % (n)

0.2 (2)

0.3 (8)

Creatinine, mean change at week 12, mg/dL

-0.002 ± 0.11

0.046 ± 0.12

Uric acid, mean change at week 12, mg/dL

-0.02 ± 0.82

0.82 ± 0.97

Haemoglobin, mean change at week 12, g/dL

0.06 ± 0.69

-0.31 ± 0.71

The free consultation period for this content is over.

It is now only available year-round to ESC Professional Members, Fellows of the ESC, and Young combined Members

Members get more

Join now
  • 1ESC Professional Members – access all resources from general ESC events 
  • 2ESC Association Members (Ivory, Silver, Gold) – access your Association’s resources
  • 3Under 40 or in training - with a Combined Membership, access all resources
Join now

Our sponsors

ESC 365 is supported by Bayer, Boehringer Ingelheim and Lilly Alliance, Bristol-Myers Squibb and Pfizer Alliance, Novartis Pharma AG and Vifor Pharma in the form of educational grants. The sponsors were not involved in the development of this platform and had no influence on its content.

logo esc

Our mission: To reduce the burden of cardiovascular disease

Who we are