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

Mostra el registre complet Registre parcial de l'ítem

  • dc.contributor.author Coloma, Preciosa M.ca
  • dc.contributor.author Furlong, Laura I., 1971-ca
  • dc.contributor.author Bauer-Mehren, Annaca
  • dc.contributor.author Sanz, Ferranca
  • dc.contributor.author Mestres i López, Jordica
  • dc.contributor.author Sturkenboom, Miriamca
  • dc.date.accessioned 2015-05-15T07:10:17Z
  • dc.date.available 2015-05-15T07:10:17Z
  • dc.date.issued 2013ca
  • dc.description.abstract 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.en
  • dc.description.sponsorship This research has been funded by the European Commission’s Seventh Framework Programme (FP7/2007–2013) under grant no. 215847–The EU-ADR Project.en
  • dc.format.mimetype application/pdfca
  • dc.identifier.citation Coloma PM, Schuemie MJ, Trifiro G, Furlong L, van Mulligen E, Bauer-Mehren A et al. Drug-induced acute myocardial infarction: identifying 'prime suspects' from electronic healthcare records-based surveillance system. PLoS ONE. 2013;8(8):e72148. DOI: 10.1371/journal.pone.0072148ca
  • dc.identifier.doi http://dx.doi.org/10.1371/journal.pone.0072148
  • dc.identifier.issn 1932-6203ca
  • dc.identifier.uri http://hdl.handle.net/10230/23582
  • dc.language.iso engca
  • dc.publisher Public Library of Science (PLoS)ca
  • dc.relation.ispartof PLoS ONE. 2013;8(8):e72148
  • dc.relation.projectID info:eu-repo/grantAgreement/EC/FP7/215847ca
  • dc.rights © Coloma et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.en
  • dc.rights.accessRights info:eu-repo/semantics/openAccessca
  • dc.subject.other Medicaments -- Efectes secundarisca
  • dc.title Drug-induced acute myocardial infarction: identifying 'prime suspects' from electronic healthcare records-based surveillance systemen
  • dc.type info:eu-repo/semantics/articleca
  • dc.type.version info:eu-repo/semantics/publishedVersionca

Col·leccions

Articles (Departament de Medicina i Ciències de la Vida)
Articles (Hospital del Mar Research Institute)
Documents OpenAIRE (Open Access Infrastructure for Research in Europe)