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Drug Saf. 2018 Nov;41(11):1049-1058. doi: 10.1007/s40264-018-0686-7.

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

Author information

1
Bordeaux PharmacoEpi, INSERM CIC1401, University of Bordeaux, CHU de Bordeaux, 146 rue Leo Saignat, 33076, Bordeaux, France.
2
INSERM U1219, 33076, Bordeaux, France.
3
OXON Epidemiology, London, UK.
4
Bordeaux PharmacoEpi, INSERM CIC1401, University of Bordeaux, CHU de Bordeaux, 146 rue Leo Saignat, 33076, Bordeaux, France. nicholas.moore@u-bordeaux.fr.
5
INSERM U1219, 33076, Bordeaux, France. nicholas.moore@u-bordeaux.fr.

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.

PMID:
29797240
DOI:
10.1007/s40264-018-0686-7
[Indexed for MEDLINE]

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