Bempedoic acid lowers high-sensitivity C-reactive protein and low-density lipoprotein cholesterol: Analysis of pooled data from four phase 3 clinical trials
- PMID: 37075696
- DOI: 10.1016/j.atherosclerosis.2023.03.020
Bempedoic acid lowers high-sensitivity C-reactive protein and low-density lipoprotein cholesterol: Analysis of pooled data from four phase 3 clinical trials
Abstract
Background and aims: High-sensitivity C-reactive protein (hsCRP), a marker for atherosclerotic cardiovascular disease risk, is reduced by bempedoic acid. We assessed the relationship between changes in low-density lipoprotein cholesterol (LDL-C) and hsCRP in relation to baseline statin use.
Methods: Pooled data from four phase 3 trials (patients on maximally tolerated statins [Pool 1] and patients receiving no or low-dose statins [Pool 2]) were used to determine the proportion of patients with baseline hsCRP ≥2 mg/L who achieved hsCRP <2 mg/L at week 12. The percentage of patients who achieved hsCRP <2 mg/L and guideline-recommended LDL-C (Pool 1, <70 mg/dL; Pool 2, <100 mg/dL) was determined for patients on statins in Pool 1 and those not on statins in Pool 2, as was the correlation between percent changes in hsCRP and LDL-C.
Results: Overall, 38.7% in Pool 1 and 40.7% in Pool 2 with baseline hsCRP ≥2 mg/L achieved hsCRP <2 mg/L with bempedoic acid, with little effect from background statin. Among patients taking a statin in Pool 1 or not taking a statin in Pool 2, 68.6% and 62.4% achieved hsCRP <2 mg/L. Both hsCRP <2 mg/L and United States guideline-recommended LDL-C were achieved more often with bempedoic acid vs. placebo (20.8% vs. 4.3%, respectively, in Pool 1 and 32.0% vs. 5.3%, in Pool 2). Changes in hsCRP and LDL-C were only weakly correlated (Pool 1, r = 0.112; Pool 2, r = 0.173).
Conclusions: Bempedoic acid significantly reduced hsCRP irrespective of background statin therapy; the effect was largely independent of LDL-C lowering.
Keywords: Atherosclerotic cardiovascular disease; C-reactive protein; Hyperlipidemia; Inflammation.
Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.
Conflict of interest statement
Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Stroes has received research grant(s)/support to his institution from Amgen, Sanofi, Resverlogix, and Athera and has received lecturing/advisory board fees from Amgen, Sanofi, Akcea/IONIS, Esperion Therapeutics, Inc., and Novartis. Dr. Bays’s research site has received research grants from 89Bio, Acasti, Akcea, Allergan, Alon Medtech/Epitomee, Amarin, Amgen, AstraZeneca, Axsome, Boehringer Ingelheim, Civi, Eli Lilly, Esperion Therapeutics, Inc., Evidera, Gan and Lee, Home Access, Janssen, Johnson and Johnson, Lexicon, Matinas, Merck, Metavant, Novartis, NovoNordisk, Pfizer, Regeneron, Sanofi, Selecta, TIMI, and Urovant. He has served as a consultant/advisor for 89Bio, Amarin, Esperion Therapeutics, Inc., Matinas, and Gelesis and as a speaker for Esperion. Dr. Banach has received research grant(s)/support from Amgen, Sanofi, Valeant, and Viatris, has served as a consultant for or received honoraria from Abbott Medical, Abbott Vascular, Amgen, Esperion Therapeutics, Inc., Freia Pharmaceuticals, Herbapol, Kogen, KRKA, Mylan/Viatris, Novartis, Novo Nordisk, Polpharma, Polfarmex, Regeneron, Sanofi-Aventis, Servier, Valeant, Daichii Sankyo, Teva, and Zentiva, and is CMO at Nomi Biotech Corporation Ltd. Dr. Catapano has received research grant(s)/support from Sanofi, Sanofi Regeneron, Amgen, Amarin, Mylan, and Menarini (all paid to the institution, not to the individual), and has served as a consultant for or received honoraria from Akcea, Amarin, Amgen, Sanofi, Esperion Therapeutics, Inc., Kowa, Novartis, Ionis Pharmaceuticals, Medco, Mylan, Menarini, MSD, Recordati, Regeneron, and Daiichi Sankyo. Dr. Duell has received institutional research grant(s)/support from Travere/Retrophin and Regenxbio, and served as a consultant for Akcea/Ionis, Kaneka, Novo Nordisk, Retrophin, and Regeneron. Dr. Laufs has served as a consultant for Amgen, Daiichi Sankyo, Esperion Therapeutics, Inc., and Sanofi. Dr. Mancini received research grant(s)/support from Merck, AstraZeneca, Amgen, Sanofi, Novo Nordisk, Boehringer Ingelheim, Lilly, Pfizer, HLS Therapeutics, and Bayer and has served as a consultant for these companies as well as for Esperion Therapeutics, Inc., Novartis, and Servier. Dr. Ray has received research grant(s)/support from Amgen, Daiichi Sankyo, MSD, Pfizer, Regeneron, and Sanofi (all paid to the institution, not to the individual), and served as a consultant for or received honoraria from AbbVie, Akcea, Algorithm, Amgen, AstraZeneca, Boehringer Ingelheim, Cerenis, Cipla, Daiichi Sankyo, Dr. Reddy’s Laboratories, Lilly, Esperion Therapeutics, Inc., Kowa, Medco, MSD, Novo Nordisk, Pfizer, Regeneron, Resverlogix, Sanofi, Takeda, and Zuellig Pharma. Dr. Gotto is an Esperion Therapeutics, Inc. board member and Akcea DSMB chair. He has also served as a consultant for Kowa. Dr. Sasiela is a former employee of Esperion Therapeutics, Inc., and may hold stock and/or stock options. He is currently the principal of Cardiometabolic Consulting, LLC. Dr. Zhang was an employee of Esperion Therapeutics, Inc. when the analysis was carried out and may hold stock and/or stock options.
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