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Epidemiology
Research
Adverse drug reactions to anticoagulants in Spain: analysis of the Spanish National Hospital Discharge Data (2010–2013)
  1. P Carrasco-Garrido1,
  2. V Hernández-Barrera1,
  3. J Esteban-Hernández1,
  4. I Jiménez-Trujillo1,
  5. A Álvaro-Meca1,
  6. A López de Andrés1,
  7. J de Miguel Diez2,
  8. J M Rodríguez Barrios3,
  9. J A Muñoz Robles4,
  10. R Jiménez-García1
  1. 1Preventive Medicine and Public Health Teaching and Research Unit, Health Sciences Faculty Rey Juan Carlos University, Alcorcón, Spain
  2. 2Pneumology Department, Hospital General Universitario Gregorio Marañon, Madrid, Spain
  3. 3Daiichi Sankyo Europe GmbH, Berlin, Germany
  4. 4Daiichi Sankyo España, S.A, Madrid, Spain
  1. Correspondence to Dr P Carrasco-Garrido; pilar.carrasco{at}urjc.es

Abstract

Objective To describe and analyse hospitalisations for adverse drug reactions (ADRs) involving anticoagulants. We also analysed the progress of the reactions over time, the factors related with ADRs.

Design A retrospective, descriptive, epidemiological study.

Setting This study used the Spanish National Hospital Discharge Database (Conjunto Mínimo Básico de Datos, CMBD), over a 4-year period.

Participants We selected CMBD data corresponding to hospital discharges with a diagnosis of ADRs to anticoagulants (International Classification of Diseases-Ninth Revision, Clinical Modification (ICD-9-CM) code E934.2) in any diagnostic field during the study period.

Main outcome measures We calculated the annual incidence of ADRs to anticoagulants according to sex and age groups. The median lengths of hospital stay and in-hospital mortality (IHM) were also estimated for each year studied. Bivariate analyses of the changes in variables according to year were based on Poisson regression. IHM was analysed using logistic regression models. The estimates were expressed as ORs and their 95% CI.

Results During the study period, 50 042 patients were hospitalised because of ADRs to anticoagulants (6.38% of all ADR-related admissions). The number of cases increased from 10 415 in 2010 to 13 891 in 2013. Cumulative incidence of ADRs to anticoagulants was significantly higher for men than women and in all age groups. An adjusted multivariate analysis revealed that IHM did not change significantly over time. We observed a statistically significant association between IHM and age, with the highest risk for the ≥85 age group (OR 2.67; 95% CI 2.44 to 2.93).

Conclusions The incidence of ADRs to anticoagulants in Spain increased from 2010 to 2013, and was significantly higher for men than women and in all age groups. Older patients were particularly susceptible to being hospitalised with an adverse reaction to an anticoagulant.

  • Adverse Drug Reactions
  • anticoagulants
  • National Hospital Discharge Data

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-013224

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    Footnotes

    • Contributors All authors contributed to the conception and design of the study. PC-G and RJ-G originated and designed the study and coordinated the writing of the article. VH-B contributed to the analysis of the data and to the drafting of the paper. JE-H, IJ-T, AA-M, ALdA, JdMD, JMRB and JAMR contributed to the interpretation of the results and to the drafting of the paper. All authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors have seen and approved the final version. PC-G is the guarantor.

    • Funding This study forms part of research funded by the Daiichi Sankyo España, S.A grant no: 2015/00200/001-A295.

    • Competing interests None declared.

    • Ethics approval The study protocol was approved by the Ethics Committee of Universidad Rey Juan Carlos.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.