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Sécurité d’emploi de l’ibuprofène en prescription médicale facultative chez l’adulte : méta-analyse comparative ibuprofène versus placebo et paracétamol

The safe use of ibuprofen on facultative medical prescription in adults: a comparative meta-analysis of ibuprofen versus placebo and paracetamol

  • Article Original / Original Article
  • Published:
Douleur et Analgésie

Résumé

L’ibuprofène est un des principaux antalgiques de prescription médicale facultative. Afin de préciser sa sécurité d’emploi, une méta-analyse a été réalisée en considérant toutes les études thérapeutiques contrôlées (ETCs) (publiées jusqu’en mars 2013) ayant concerné l’ibuprofène dans les conditions de son utilisation en prescription médicale facultative (posologie ≤ 1 200 mg/j; durée courte ≤ 5 jours). Cette méta-analyse a intégré 128 comparaisons de l’ibuprofène avec le placebo et le paracétamol. Elle a mis en évidence une réduction du risque de survenue d’événements indésirables de toute nature avec l’ibuprofène versus le placebo lors d’une utilisation tant en prise unique (odds ratio [OR]: 0,85; IC 95 %: [0,72–0,99]) qu’en prises multiples (OR: 0,81; IC 95 %: [0,68–0,96]). Une réduction du risque a également été mise en évidence par rapport au paracétamol lors d’une utilisation en prise unique (OR: 0,43; IC 95 %: [0,28–0,66]), ce risque n’étant pas statistiquement différent lors de la comparaison ibuprofène versus paracétamol pour une utilisation en prises multiples (OR: 0,93; IC 95 %: [0,81–1,1]). Concernant les critères spécifiques de sécurité d’emploi (dont les événements indésirables gastrointestinaux), cette méta-analyse n’a pas mis en évidence d’augmentation statistiquement significative de la fréquence d’un événement indésirable particulier par rapport au placebo ou au paracétamol.

Abstract

Ibuprofen is one of the main over-the-counter (OTC) analgesics. To evaluate its safety, a meta-analysis was performed considering all controlled clinical trials (published up to March 2013) with ibuprofen used under OTC conditions (dose ≤ 1,200 mg/d; short duration ≤ 5 days). This metaanalysis included 128 comparisons with placebo or paracetamol. It showed a risk reduction of any adverse events with ibuprofen versus placebo when used as a single dose (odds ratio [OR]: 0.85; 95% CI: [0.72–0.99]) or when used in multiple dosing (OR: 0.81; 95% CI: [0.68–0.96]). The same effect was also demonstrated for ibuprofen versus paracetamol when used as a single dose (OR: 0.43; 95% CI: [0.28–0.66]); this risk reduction is not statistically different when comparing ibuprofen versus paracetamol for use in multiple dosing (OR: 0.93; 95% CI: [0.81–1.1]). Regarding the specific criteria of safety (including gastrointestinal adverse events), this metaanalysis has not shown a statistically significant increase in the frequency of a particular adverse event with ibuprofen compared against placebo or paracetamol.

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Authors and Affiliations

  1. Département d’évaluation et traitement de la douleur, pôle neurosciences cliniques, CHU de Nice, hôpital de Cimiez, 4, avenue Reine-Victoria, F-06300, Nice, France

    M. Lantéri-Minet

  2. Inserm/UdA, U1107, Neuro-Dol, Trigeminal Pain and Migraine, université d’Auvergne, F-63000, Clermont-Ferrand, France

    M. Lantéri-Minet

  3. CNRS, UMR 5558 CNRS, F-69100, Villeurbanne, France

    M. Cucherat

  4. Département des affaires médicales et réglementaires, Reckitt-Benckiser Healthcare France, F-91300, Massy, France

    A. Benkhelil

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  1. M. Lantéri-Minet
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  3. A. Benkhelil
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Lantéri-Minet, M., Cucherat, M. & Benkhelil, A. Sécurité d’emploi de l’ibuprofène en prescription médicale facultative chez l’adulte : méta-analyse comparative ibuprofène versus placebo et paracétamol. Douleur analg 28, 100–115 (2015). https://doi.org/10.1007/s11724-015-0420-5

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  • DOI: https://doi.org/10.1007/s11724-015-0420-5

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