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Original Research

Real-world safety of icosapent ethyl: analysis based on spontaneous reports in FAERS database

ORCID Icon, , , , & ORCID Icon
Pages 373-383 | Received 04 Sep 2023, Accepted 19 Oct 2023, Published online: 27 Oct 2023

References

  • Benjamin EJ, Muntner P, Alonso A, et al. Heart disease and stroke statistics—2019 update: a report from the American Heart association. Circulation. 2019;139(10):e56–e528. doi: 10.1161/CIR.0000000000000659
  • Roth GA, Johnson C, Abajobir A, et al. Global, regional, and national burden of cardiovascular diseases for 10 causes, 1990 to 2015. J Am Coll Cardiol. 2017;70(1):1–25. doi: 10.1016/j.jacc.2017.04.052
  • Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330–343. doi: 10.1016/j.jacc.2018.04.061
  • Ference BA, Kastelein JJP, Ray KK, et al. Association of triglyceride-lowering LPL variants and LDL-C–lowering LDLR variants with risk of coronary Heart disease. JAMA. 2019;321(4):364. doi: 10.1001/jama.2018.20045
  • Fan W, Philip S, Granowitz C, et al. Hypertriglyceridemia in statin-treated US adults: the national health and nutrition examination survey. J Clin Lipidol. 2019;13(1):100–108. doi: 10.1016/j.jacl.2018.11.008
  • Sumner AE, Cowie CC. Ethnic differences in the ability of triglyceride levels to identify insulin resistance. Atherosclerosis. 2008;196(2):696–703. doi: 10.1016/j.atherosclerosis.2006.12.018
  • Toth PP, Fazio S, Wong ND, et al. Risk of cardiovascular events in patients with hypertriglyceridaemia: a review of real-world evidence. Diab Obes Metab. 2020;22(3):279–289. doi: 10.1111/dom.13921
  • Handelsman Y, Jellinger PS, Guerin CK, et al. Consensus statement by the American association of clinical endocrinologists and American college of endocrinology on the management of dyslipidemia and prevention of cardiovascular disease algorithm – 2020 executive summary. Endocr Pract. 2020;26(10):1196–1224. doi: 10.4158/CS-2020-0490
  • Bhatt DL, Steg PG, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380(1):11–22. doi: 10.1056/NEJMoa1812792
  • Food and drug administration (FDA). The label of icosapent ethyl [EB/OL]. Dec 2019. [cited 2023 Apr 2]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202057s035lbl.pdf
  • European Medicines Agency(EMA). Vazkepa: EPAR-Product information [EB/OL]. Mar 2021. [cited 2023 Apr 2] Available from: www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf
  • Visseren F, Mach F, Smulders YM, et al. ESC guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2021. 2021;42(34):3227–3337.
  • Ballantyne CM, Bays HE, Kastelein JJ, et al. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). Am J Cardiol. 2012;110(7):984–992. doi: 10.1016/j.amjcard.2012.05.031
  • Davis SE, Zabotka L, Desai RJ, et al. Use of electronic Health record data for drug safety signal Identification: a scoping review. Drug Saf. 2023;46(8):725–742. doi: 10.1007/s40264-023-01325-0
  • Gatti M, Antonazzo IC, Diemberger I, et al. Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system. Eur J Prev Cardiol. 2021;28(9):983–989. doi: 10.1177/2047487320915663
  • Food and drug administration adverse event reporting system (FAERS). [cited 2023 Apr 25]. Available from: https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.
  • European Medicines Agency. Screening for adverse reactions in EudraVigilance. EMA/849944/2016. 2016 [cited 2023 May 2]:p. 3–33. Available from: https://www.ema.europa.eu/en/documents/other/screening-adverse-reactions-eudravigilance_en.pdf
  • Huang L, Guo T, Zalkikar JN, et al. A review of statistical Methods for safety surveillance. Ther Innov Regul Sci. 2014;48(1):98–108. doi: 10.1177/2168479013514236
  • Shu Y, He X, Wu P, et al. Gastrointestinal adverse events associated with semaglutide: a pharmacovigilance study based on FDA adverse event reporting system. Front Public Health. 2022;10:996179. doi: 10.3389/fpubh.2022.996179
  • Guo H, Wang B, Yuan S, et al. Neurological adverse events associated with Esketamine: a disproportionality analysis for signal detection leveraging the FDA adverse event reporting system. Front Pharmacol. 2022;13:849758. doi: 10.3389/fphar.2022.849758
  • Shu Y, Wang L, Ding Y, et al. Disproportionality analysis of abemaciclib in the FDA adverse event reporting system: a real-world post-marketing pharmacovigilance assessment. Drug Saf. 2023;46(9):881–895. doi: 10.1007/s40264-023-01334-z
  • European Medicines Agency. Designated medical event (DME) list. EMA/326038/2020. 2020. [cited 2023 May 3]. Available from: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management#designated-medical-events-section
  • European Medicines Agency. MedDRA important medical event terms list - version 26.0. EMA/135819/2023. 2023. [cited 2023 May 3]. Available from: https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-system-overview
  • Fusaroli M, Isgro V, Cutroneo PM, et al. Post-marketing surveillance of CAR-T-Cell therapies: analysis of the FDA adverse event reporting system (FAERS) database. Drug Saf. 2022;45(8):891–908. doi: 10.1007/s40264-022-01194-z
  • Kaku K, Nakayama Y, Yabuuchi J, et al. Safety and effectiveness of empagliflozin in clinical practice as monotherapy or with other glucose-lowering drugs in Japanese patients with type 2 diabetes: subgroup analysis of a 3-year post-marketing surveillance study. Expert Opinion On Drug Safety. 2023;22(9):819–832. doi: 10.1080/14740338.2023.2213477
  • Setyawan J, Azimi N, Strand V, et al. Reporting of thromboembolic events with JAK inhibitors: analysis of the FAERS database 2010–2019. Drug Saf. 2021;44(8):889–897. doi: 10.1007/s40264-021-01082-y
  • Shu Y, Ding Y, Dai B, et al. A real-world pharmacovigilance study of axitinib: data mining of the public version of FDA adverse event reporting system. Expert Opin Drug Saf. 2022;21(4):563–572. doi: 10.1080/14740338.2022.2016696
  • Mazhar F, Battini V, Gringeri M, et al. The impact of anti-TNFα agents on weight-related changes: new insights from a real-world pharmacovigilance study using the FDA adverse event reporting system (FAERS) database. Expert Opin Biol Ther. 2021;21(9):1281–1290. doi: 10.1080/14712598.2021.1948529
  • Kinoshita S, Hosomi K, Yokoyama S, et al. Time-to-onset analysis of amiodarone-associated thyroid dysfunction. J Clin Pharm Ther. 2020;45(1):65–71. doi: 10.1111/jcpt.13024
  • Cornelius VR, Sauzet O, Evans SJ. A signal detection method to detect adverse drug reactions using a parametric time-to-event model in simulated cohort data. Drug Saf. 2012;35(7):599–610. doi: 10.2165/11599740-000000000-00000
  • Islam N, Cichero E, Rahman S, et al. Novel pulmonary delivery of drugs for the management of atrial fibrillation. Am J Cardiovasc Drugs. 2023;23(1):1–7. doi: 10.1007/s40256-022-00551-8
  • Ruscica M, Sirtori CR, Carugo S, et al. Omega-3 and cardiovascular prevention – is this still a choice? Pharmacological Research. 2022;182:106342. doi: 10.1016/j.phrs.2022.106342
  • Bays HE. Safety considerations with omega-3 fatty acid therapy. Am J Cardiol. 2007;99(6):S35–S43. doi: 10.1016/j.amjcard.2006.11.020
  • Harris WS. Expert opinion: omega-3 fatty acids and bleeding-cause for concern? Am J Cardiol. 2007;99(6):S44–S46. doi: 10.1016/j.amjcard.2006.11.021
  • Sheikh O, Vande Hei AG, Battisha A, et al. Cardiovascular, electrophysiologic, and hematologic effects of omega-3 fatty acids beyond reducing hypertriglyceridemia: as it pertains to the recently published REDUCE-IT trial. Cardiovasc Diabetol. 2019;18(1):84. doi: 10.1186/s12933-019-0887-0
  • Olshansky B, Bhatt DL, Miller M, et al. Cardiovascular benefits of icosapent ethyl in patients with and without atrial fibrillation in REDUCE-IT. J Am Heart Assoc. 2023;12(5):e26756. doi: 10.1161/JAHA.121.026756
  • Kalstad AA, Myhre PL, Laake K, et al. Effects of n-3 fatty acid supplements in elderly patients after myocardial infarction. Circulation. 2021;143(6):528–539. doi: 10.1161/CIRCULATIONAHA.120.052209
  • Nicholls SJ, Lincoff AM, Garcia M, et al. Effect of high-dose omega-3 fatty acids vs corn oil on major adverse cardiovascular events in patients at high cardiovascular risk. JAMA. 2020;324(22):2268. doi: 10.1001/jama.2020.22258
  • Billman GE. The effects of omega-3 polyunsaturated fatty acids on cardiac rhythm: a critical reassessment. Pharmacol Ther. 2013;140(1):53–80. doi: 10.1016/j.pharmthera.2013.05.011
  • Ruscica M, Ferri N, Banach M, et al. Side effects of statins: from pathophysiology and epidemiology to diagnostic and therapeutic implications. Cardiovasc Res. 2023;118(17):3288–3304. doi: 10.1093/cvr/cvac020
  • Bytyci I, Penson PE, Mikhailidis DP, et al. Prevalence of statin intolerance: a meta-analysis. Eur Heart J. 2022;43(34):3213–3223. doi: 10.1093/eurheartj/ehac015
  • Chapman MJ, Zamorano JL, Parhofer KG. Reducing residual cardiovascular risk in Europe: therapeutic implications of European medicines agency approval of icosapent ethyl/eicosapentaenoic acid. Pharmacol Ther. 2022;237:108172

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