@article{e3986830c79f47748eb7979bdb5908fc,
title = "Efficacy and safety of bempedoic acid in patients not receiving statins in phase 3 clinical trials",
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.",
keywords = "Bempedoic acid, Ezetimibe, Low-density lipoprotein cholesterol, Statin, Statin intolerance, Statin-associated muscle symptoms (SAMS)",
author = "Ulrich Laufs and Ballantyne, {Christie M.} and Maciej Banach and Harold Bays and Catapano, {Alberico L.} and Duell, {P. Barton} and Goldberg, {Anne C.} and Gotto, {Antonio M.} and Leiter, {Lawrence A.} and Ray, {Kausik K.} and Bloedon, {Le Anne T.} and Diane MacDougall and Yang Zhang and Mancini, {G. B.John}",
note = "Funding Information: L.A.L. has received research grant(s)/support from Amgen, AstraZeneca, Kowa, The Medicines Company, Novartis, and Sanofi. He has also served as an advisor and/or provided CME on behalf of Amarin, Amgen, AstraZeneca, Esperion, HLS, Merck, Novartis, Pfizer, and Sanofi. Funding Information: P.B.D. has received institutional research grant(s)/support from Regeneron, Regenxbio, and Retrophin/Travere, and has served as a consultant for Akcea, Amryt, Esperion, Kaneka, and Regeneron. Funding Information: K.K.R. acknowledges support from the NIHR Imperial Biomedical Research Centre. A.L.C. acknowledges support from Ministero della Salute ricerca corrente. Clinical trials included in this analysis were funded by Esperion Therapeutics, Inc. Esperion participated in the study design, research, data collection, analysis and interpretation of data and writing, reviewing, and approving the manuscript. All authors had access to the data and participated in the development, review, and approval of the manuscript. Medical writing assistance, funded by Esperion, was provided by Lamara D. Shrode, PhD, CMPP, of JB Ashtin. The data, analytic methods, and study materials will not be made available to other researchers for purposes of reproducing the results or replicating the procedures. Funding: This work was supported by Esperion Therapeutics, Inc. Funding Information: Funding: This work was supported by Esperion Therapeutics, Inc. Funding Information: C.M.B. has received research grant(s)/support paid to his institution from Abbott Diagnostic, Akcea, Amarin, Amgen, Esperion, Ionis, Novartis, Regeneron, Roche Diagnostic, Sanofi-Synthelabo, NIH, AHA, and ADA; consulting fees from Abbott Diagnostics, Amarin, Amgen, Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Esperion, Genentech, Intercept, Matinas BioPharma Inc., Merck, Novartis, Novo Nordisk, Regeneron, Roche Diagnostic, and Sanofi-Synthelabo. Funding Information: G.B.J.M. has received research grant(s)/support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novo Nordisk, and Sanofi, and has served as a consultant for these companies as well as Esperion, Novartis, Amgen, and Sanofi Servier. Funding Information: M.B. has received research grant(s)/support from Amgen, Sanofi, Mylan/Viatris, and Valeant, and has served as a consultant for Amgen, Daichii Sankyo, Esperion, Freia Pharmaceuticals, Herbapol, Kogen, KRKA, Novartis, Novo Nordisk, Polfarmex, Polpharma, Regeneron, Sanofi-Aventis, Servier, Teva, and Zentiva; he serves as CMO at Nomi Biotech Corporation Ltd. Funding Information: U.L. has served as a consultant for Amarin, Amgen, Daiichi Sankyo, Esperion, and Sanofi and has received institutional research grants from Daiichi Sankyo and Novartis. Funding Information: H.B. has received research grants from 89Bio, Acasti, Akcea, Allergan, Alon Medtech/Epitomee, Amarin, Amgen, AstraZeneca, Axsome, Boehringer Ingelheim, Civi, Eli Lilly, Esperion, 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, Matinas, and Gelesis, and speaker for Esperion. Funding Information: A.C.G. has received research grant(s)/support from Amgen, Akcea/IONIS, Merck, Novartis, Pfizer, Regeneron, and Sanofi; has served as a consultant for Akcea, Esperion, Novartis, Regeneron, and Sanofi; and has provided editorial work for Merck. Publisher Copyright: {\textcopyright} 2022",
year = "2022",
month = may,
day = "1",
doi = "10.1016/j.jacl.2022.03.001",
language = "English",
volume = "16",
pages = "286--297",
journal = "Journal of Clinical Lipidology",
issn = "1933-2874",
number = "3",
}