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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)

Authors:
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 ,

Citation:

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

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