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Risk of nonfatal acute myocardial infarction associated with non-steroidal antiinflammatory drugs, non-narcotic analgesics and other drugs used in osteoarthritis: a nested case-control study

Authors

  • Francisco J. de Abajo,

    Corresponding author
    1. Clinical Pharmacology Unit, University Hospital ‘Príncipe de Asturias’, Madrid, Spain
    2. Department of Biomedical Sciences, School of Medicine and Health Sciences, University of Alcalá, Madrid, Spain
    • Correspondence to: F. J. de Abajo, Departmento de Ciencias Biomédicas, Universidad de Alcalá, Ctra. Madrid-Barcelona km. 33.6, 28871 Alcalá de Henares, Madrid, Spain. E-mail: francisco.abajo@uah.es

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  • Miguel J. Gil,

    1. BIFAP Research Unit, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices, Madrid, Spain
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  • Patricia García Poza,

    1. Clinical Pharmacology Unit, University Hospital ‘Príncipe de Asturias’, Madrid, Spain
    2. Department of Biomedical Sciences, School of Medicine and Health Sciences, University of Alcalá, Madrid, Spain
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  • Verónica Bryant,

    1. BIFAP Research Unit, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices, Madrid, Spain
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  • Belén Oliva,

    1. BIFAP Research Unit, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices, Madrid, Spain
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  • Julia Timoner,

    1. BIFAP Research Unit, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices, Madrid, Spain
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  • Luis A. García-Rodríguez

    1. Spanish Centre for Pharmacoepidemiological Research (CEIFE), Madrid, Spain
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  • Statement about previous postings and presentations: due to the regulatory implications of the present study, the main results on tNSAIDs were presented to the Committee on Safety of Medicines for Human Use of the Spanish Agency for Medicines and Medical Devices (AEMPS). Also, this information was shared, under strict confidential measures, with the members of the Pharmacovigilance and Risk Assessment Committee of the European Medicines Agency.

ABSTRACT

Purpose

The purpose of this study is to estimate the risk of nonfatal acute myocardial infarction (AMI) associated with traditional NSAIDs (tNSAIDs), non-narcotic analgesics (paracetamol and metamizole), and symptomatic slow-acting drugs in osteoarthritis (SYSADOAs) overall and in different subgroups of patients.

Methods

We performed a nested case-control study using a Primary Care Database (Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria), over the study period, 2001–2007. We included patients aged 40–90 years, with nonfatal AMI and randomly selected controls matched for age, sex and calendar year. Exposure to drugs was assessed within a 30-day window before the index date.

Results

We did not find an association with nonfatal AMI in patients at low-intermediate background cardiovascular risk (odds ratio = 0.92; 95% confidence interval: 0.76–1.12), whereas there was a moderate significant association among those at high risk (1.28; 1.06–1.54) or when tNSAIDs were used for longer than 365 days (1.43; 1.12–1.82). The greatest risk occurred when these two conditions were combined (1.80; 1.26–2.58). The risk varied across individual tNSAIDs, with ibuprofen (0.95; 0.78–1.16) in the lower and aceclofenac (1.59; 1.15–2.19) in the upper part of the range. Low-dose aspirin did not modify the risk profile showed by any of the individual tNSAIDs examined. Paracetamol (0.84; 0.74–0.95), metamizole (1.06; 0.87–1.29) and SYSADOAs (0.68; 0.47–0.99) were not associated with an increased risk overall or in any subgroup of patients.

Conclusions

The risk of nonfatal AMI varied with individual tNSAIDs, duration of treatment and background cardiovascular risk. Paracetamol, metamizole and SYSADOAs did not increase the risk in any of the conditions examined. Copyright © 2014 John Wiley & Sons, Ltd.

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