دورية أكاديمية
أعرض في EDS

Drug-induced acute myocardial infarction: identifying 'prime suspects' from electronic healthcare records-based surveillance system.

التفاصيل البيبلوغرافية
العنوان: Drug-induced acute myocardial infarction: identifying 'prime suspects' from electronic healthcare records-based surveillance system.
المؤلفون: Coloma PM; Department of Medical Informatics, Erasmus MC University Medical Center, Rotterdam, The Netherlands., Schuemie MJ, Trifirò G, Furlong L, van Mulligen E, Bauer-Mehren A, Avillach P, Kors J, Sanz F, Mestres J, Oliveira JL, Boyer S, Helgee EA, Molokhia M, Matthews J, Prieto-Merino D, Gini R, Herings R, Mazzaglia G, Picelli G, Scotti L, Pedersen L, van der Lei J, Sturkenboom M
مؤلفون مشاركون: EU-ADR consortium
المصدر: PloS one [PLoS One] 2013 Aug 28; Vol. 8 (8), pp. e72148. Date of Electronic Publication: 2013 Aug 28 (Print Publication: 2013).
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: Myocardial Infarction/*chemically induced, Acute Disease ; Adverse Drug Reaction Reporting Systems ; Azithromycin/adverse effects ; Azithromycin/therapeutic use ; Betamethasone/adverse effects ; Betamethasone/therapeutic use ; Cisapride/adverse effects ; Cisapride/therapeutic use ; Domperidone/adverse effects ; Domperidone/therapeutic use ; Electronic Health Records ; Fluconazole/adverse effects ; Fluconazole/therapeutic use ; Humans ; Megestrol Acetate/adverse effects ; Megestrol Acetate/therapeutic use ; Metoclopramide/adverse effects ; Metoclopramide/therapeutic use
مستخلص: Background: Drug-related adverse events remain an important cause of morbidity and mortality and impose huge burden on healthcare costs. Routinely collected electronic healthcare data give a good snapshot of how drugs are being used in 'real-world' settings.
Objective: To describe a strategy that identifies potentially drug-induced acute myocardial infarction (AMI) from a large international healthcare data network.
Methods: Post-marketing safety surveillance was conducted in seven population-based healthcare databases in three countries (Denmark, Italy, and the Netherlands) using anonymised demographic, clinical, and prescription/dispensing data representing 21,171,291 individuals with 154,474,063 person-years of follow-up in the period 1996-2010. Primary care physicians' medical records and administrative claims containing reimbursements for filled prescriptions, laboratory tests, and hospitalisations were evaluated using a three-tier triage system of detection, filtering, and substantiation that generated a list of drugs potentially associated with AMI. Outcome of interest was statistically significant increased risk of AMI during drug exposure that has not been previously described in current literature and is biologically plausible.
Results: Overall, 163 drugs were identified to be associated with increased risk of AMI during preliminary screening. Of these, 124 drugs were eliminated after adjustment for possible bias and confounding. With subsequent application of criteria for novelty and biological plausibility, association with AMI remained for nine drugs ('prime suspects'): azithromycin; erythromycin; roxithromycin; metoclopramide; cisapride; domperidone; betamethasone; fluconazole; and megestrol acetate.
Limitations: Although global health status, co-morbidities, and time-invariant factors were adjusted for, residual confounding cannot be ruled out.
Conclusion: A strategy to identify potentially drug-induced AMI from electronic healthcare data has been proposed that takes into account not only statistical association, but also public health relevance, novelty, and biological plausibility. Although this strategy needs to be further evaluated using other healthcare data sources, the list of 'prime suspects' makes a good starting point for further clinical, laboratory, and epidemiologic investigation.
التعليقات: Erratum in: PLoS One. 2013;8(9). doi:10.1371/annotation/8824e161-bf8f-4f78-81e0-a62a1540276d.
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معلومات مُعتمدة: PDA/02/06/056 United Kingdom DH_ Department of Health
المشرفين على المادة: 5587267Z69 (Domperidone)
83905-01-5 (Azithromycin)
8VZV102JFY (Fluconazole)
9842X06Q6M (Betamethasone)
L4YEB44I46 (Metoclopramide)
TJ2M0FR8ES (Megestrol Acetate)
UVL329170W (Cisapride)
تواريخ الأحداث: Date Created: 20130910 Date Completed: 20140522 Latest Revision: 20220330
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC3756064
DOI: 10.1371/journal.pone.0072148
PMID: 24015213
قاعدة البيانات: MEDLINE
الوصف
تدمد:1932-6203
DOI:10.1371/journal.pone.0072148