دورية أكاديمية
أعرض في EDS

Cardiac adverse events associated with lacosamide: a disproportionality analysis of the FAERS database.

التفاصيل البيبلوغرافية
العنوان: Cardiac adverse events associated with lacosamide: a disproportionality analysis of the FAERS database.
المؤلفون: Yang C; Department of Pharmacy, The First People's Hospital of Shangqiu, Shangqiu, 476000, China. ycc424@163.com., Zhao W; The University of Manchester, Manchester, M13 9PL, England., Chen H; Department of Pharmacy, The First People's Hospital of Shangqiu, Shangqiu, 476000, China., Yao Y; Department of Pharmacy, Chengde Medical University Affiliated Hospital, Chengde, 067000, China., Zhang J; Department of Pharmacy, Henan Key Laboratory for Precision Clinical Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China. fcczhangjm@zzu.edu.cn.
المصدر: Scientific reports [Sci Rep] 2024 Jul 13; Vol. 14 (1), pp. 16202. Date of Electronic Publication: 2024 Jul 13.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : Nature Publishing Group, copyright 2011-
مواضيع طبية MeSH: Lacosamide*/adverse effects , Adverse Drug Reaction Reporting Systems*/statistics & numerical data , Databases, Factual* , Anticonvulsants*/adverse effects, Humans ; Female ; Male ; Middle Aged ; United States/epidemiology ; Adult ; Aged ; United States Food and Drug Administration ; Adolescent ; Young Adult ; Cardiotoxicity/etiology ; Cardiotoxicity/epidemiology
مستخلص: Lacosamide was the first approved third-generation antiepileptic drug. However, real-world data regarding its adverse cardiac reactions in large samples still need to be completed. We evaluated the cardiac safety profile of lacosamide using the Food and Drug Administration Adverse Event Reporting System (FAERS). We performed disproportionality analysis computing reporting odds ratio (ROR) as a quantitative metric to assess the signal of lacosamide-related cardiac adverse events (AEs) from 2013 Q1 to 2022 Q4. The signal was considered significant when the lower limit of the 95% confidence interval (CI) of the ROR exceeded 1, and ≥ 5 AEs were reported. Serious and nonserious cases were compared by statistical analysis, and signals were further prioritized using a rating scale. A total of 812 cardiac AEs associated with lacosamide were identified, and 92 signals were detected, of which 17 AEs were significantly associated signals. The median time-to-onset (TTO) for moderate priority signals was 10 days, whereas for weak priority signals, it was 54 days. Notably, all cardiac AEs exhibited an early failing pattern, indicating the risk gradually decreasing. Based on the comprehensive analysis of the FAERS database and prioritization of cardiac AE signals, our research enhances the awareness among healthcare professionals regarding cardiac AEs associated with lacosamide.
(© 2024. The Author(s).)
References: Front Neurol. 2022 Jul 04;13:891368. (PMID: 35860491)
Cureus. 2021 Dec 27;13(12):e20736. (PMID: 35111429)
Epilepsy Behav. 2011 Apr;20(4):725-7. (PMID: 21411374)
Epilepsia. 2007 Jul;48(7):1308-17. (PMID: 17635557)
J Clin Pharm Ther. 2020 Feb;45(1):65-71. (PMID: 31400296)
Expert Opin Biol Ther. 2021 Sep;21(9):1281-1290. (PMID: 34191656)
Int Immunopharmacol. 2021 Jun;95:107498. (PMID: 33725634)
Epilepsy Res. 2021 Oct;176:106710. (PMID: 34265537)
Epilepsia. 2013 Jun;54(6):e90-3. (PMID: 23360388)
Epilepsia. 2015 Dec;56(12):1921-30. (PMID: 26526971)
Ther Innov Regul Sci. 2014 Jan;48(1):98-108. (PMID: 30231423)
Ann Indian Acad Neurol. 2019 Oct-Dec;22(4):529-530. (PMID: 31736597)
J Clin Med. 2021 Apr 13;10(8):. (PMID: 33924496)
Eur J Prev Cardiol. 2021 Aug 9;28(9):983-989. (PMID: 34402868)
Neurochem Res. 2017 Jul;42(7):2077-2083. (PMID: 28349359)
Aliment Pharmacol Ther. 2021 Nov;54(10):1290-1297. (PMID: 34499740)
Clin Epidemiol. 2022 Jun 28;14:789-802. (PMID: 35789689)
CNS Drugs. 2018 May;32(5):473-484. (PMID: 29785508)
N Engl J Med. 1992 Dec 10;327(24):1735-9. (PMID: 1304738)
Lancet Neurol. 2017 Jan;16(1):43-54. (PMID: 27889312)
Cardiovasc Toxicol. 2018 Dec;18(6):579-582. (PMID: 29948594)
Acta Neurol Scand. 2015 Nov;132(5):346-54. (PMID: 25932544)
Front Pharmacol. 2022 Nov 09;13:1075966. (PMID: 36438806)
Acta Neurol Scand. 2015 Nov;132(5):355-63. (PMID: 25933358)
Expert Opin Drug Saf. 2020 Feb;19(2):131-138. (PMID: 31914330)
Epilepsia. 2016 Oct;57(10):1625-1633. (PMID: 27528101)
Clin Toxicol (Phila). 2013 May;51(4):381-2. (PMID: 23534387)
Expert Opin Drug Metab Toxicol. 2017 Sep;13(9):997-1005. (PMID: 28750560)
CNS Drugs. 2009;23(7):555-68. (PMID: 19552484)
Epilepsia. 2011 Oct;52(10):e153-5. (PMID: 21801173)
Annu Rev Pharmacol Toxicol. 2020 Jan 6;60:133-154. (PMID: 31537174)
معلومات مُعتمدة: 222102310358 Key Scientific and Technology Project of Henan Province
فهرسة مساهمة: Keywords: Cardiac adverse events; Disproportionality analyses; FAERS database; Lacosamide; Reporting odds ratio
المشرفين على المادة: 563KS2PQY5 (Lacosamide)
0 (Anticonvulsants)
تواريخ الأحداث: Date Created: 20240713 Date Completed: 20240713 Latest Revision: 20240716
رمز التحديث: 20240716
مُعرف محوري في PubMed: PMC11246456
DOI: 10.1038/s41598-024-67209-0
PMID: 39003359
قاعدة البيانات: MEDLINE
الوصف
تدمد:2045-2322
DOI:10.1038/s41598-024-67209-0