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

Mai Duong, Abdelilah Abouelfath, Regis Lassalle, Cécile Droz, Patrick Blin and Nicholas Moore ()
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Mai Duong: Bordeaux PharmacoEpi, INSERM CIC1401, University of Bordeaux, CHU de Bordeaux
Abdelilah Abouelfath: Bordeaux PharmacoEpi, INSERM CIC1401, University of Bordeaux, CHU de Bordeaux
Regis Lassalle: Bordeaux PharmacoEpi, INSERM CIC1401, University of Bordeaux, CHU de Bordeaux
Cécile Droz: Bordeaux PharmacoEpi, INSERM CIC1401, University of Bordeaux, CHU de Bordeaux
Patrick Blin: Bordeaux PharmacoEpi, INSERM CIC1401, University of Bordeaux, CHU de Bordeaux
Nicholas Moore: Bordeaux PharmacoEpi, INSERM CIC1401, University of Bordeaux, CHU de Bordeaux

Drug Safety, 2018, vol. 41, issue 11, No 6, 1049-1058

Abstract: 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.

Date: 2018
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DOI: 10.1007/s40264-018-0686-7

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