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Coronary Events After Dispensing of Ibuprofen: A Propensity Score-Matched Cohort Study Versus Paracetamol in the French Nationwide Claims Database Sample

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A Commentary to this article was published on 22 August 2018

Abstract

Introduction

Non-steroidal anti-inflammatory drugs are associated with a dose and duration-dependent coronary risk. There is little information concerning analgesic-dose ibuprofen, among the most widely used drugs worldwide.

Objective

Our objective was to measure the risks of acute coronary syndrome (ACS) after dispensing of ibuprofen, versus paracetamol.

Methods

Propensity score 1:2-matched cohorts of ibuprofen or paracetamol treatment episodes (TEs) in Echantillon Généraliste de Bénéficiaires (EGB), the 1/97 sample of Système National des Données de Santé (SNDS), the French nationwide claims database, from 2009 to 2014, were compared. Outcomes were hospital admissions for ACS during the 3 months after the dispensing of ibuprofen or paracetamol. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated overall and stratified on low-dose aspirin dispensing.

Results

A total of 315,269 ibuprofen TEs in 168,400 persons were matched to 630,457 paracetamol TEs in 395,952 patients. Event rates were 50–100 times higher in low-dose aspirin users (27 vs 0.28 per 1000 patient years). Overall there was no difference in risk of ACS at 3 months (HR 0.94, 95% CI 0.74–1.20) despite a transient increase in the first 2 weeks in ibuprofen users (HR 1.70, 95% CI 1.11–2.59). In the stratified analysis, this short-term risk was only found in aspirin users (5% of population, HR 1.84, 95% CI 1.24–3.24), but not in non-aspirin users (HR 1.09, 95% CI 0.40–2.94).

Conclusions

There was no evidence for an increased risk of ACS in patients dispensed ibuprofen compared to paracetamol.

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Acknowledgements

The authors wish to thank ADERA, the non-profit organization that provides legal, administrative and human resources support to Bordeaux PharmacoEpi.

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Author notes

  1. Mai Duong

    Present address: OXON Epidemiology, London, UK

Authors and Affiliations

  1. Bordeaux PharmacoEpi, INSERM CIC1401, University of Bordeaux, CHU de Bordeaux, 146 rue Leo Saignat, 33076, Bordeaux, France

    Mai Duong, Abdelilah Abouelfath, Regis Lassalle, Cécile Droz, Patrick Blin & Nicholas Moore

  2. INSERM U1219, 33076, Bordeaux, France

    Mai Duong & Nicholas Moore

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Corresponding author

Correspondence to Nicholas Moore.

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Funding

Mai Duong received a doctoral grant from the French Embassy in Hanoi.

Conflict of interest

There are no conflicts of interest reported related to the present paper, which was funded internally by Bordeaux PharmacoEpi. Bordeaux PharmacoEpi is a public research platform of the University of Bordeaux and INSERM that has done many post-authorization studies over the years at the request of regulatory authorities, often funded by various pharmaceutical companies, but none to date concerning NSAIDs or their cardiovascular risks. Some of these studies concerned pharmaceutical companies that also manufacture NSAIDs or paracetamol. Nicholas Moore has in the past provided personal and consulting advice to pharmaceutical companies on post-authorization studies and the risks associated with NSAIDs or paracetamol, and as part of his work on data safety management boards. This includes manufacturers of ibuprofen, ketoprofen, diclofenac, naproxen, celecoxib, rofecoxib, and paracetamol, though none were involved in the present study. Mai Duong, Abdelilah Abouelfath, Regis Lassalle, Cécile Droz, Patrick Blin have no conflicts of interest that are directly relevant to the content of this study. The present study was entirely initiated, designed, implemented and reported independently of any pharmaceutical company.

Ethics considerations

This study used secondary anonymized data from the 1/97 sample of the French National Healthcare database, respecting all regulatory and legal requirements. By law, INSERM research teams can access that data without having to request further authorization from the national data protection committee, CNIL. The study protocol was deposited at INSERM before starting data access and extractions for a nihil obstat.

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Duong, M., Abouelfath, A., Lassalle, R. et al. Coronary Events After Dispensing of Ibuprofen: A Propensity Score-Matched Cohort Study Versus Paracetamol in the French Nationwide Claims Database Sample. Drug Saf 41, 1049–1058 (2018). https://doi.org/10.1007/s40264-018-0686-7

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  • DOI: https://doi.org/10.1007/s40264-018-0686-7

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