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First published online February 11, 2010

Efficacy and Safety of Ibuprofen and Acetaminophen in Children and Adults: A Meta-Analysis and Qualitative Review

Abstract

Abstract

Objective:

To evaluate the analgesic and antipyretic efficacy and safety of ibuprofen compared to acetaminophen in children and adults.

Data Sources:

Literature searches were performed using PubMed/MEDLINE (through August 2009) and EMBASE (through January 2008) and were restricted to the English language. In PubMed/MEDLINE, search terms used were ibuprofen, acetaminophen, paracetamol, clinical trials, and randomized controlled trials. EMBASE search terms included ibuprofen and acetaminophen, restricted to human and clinical trials.

Study Selection And Data Extraction:

All English-language articles identified from the data sources were reviewed. Multiple review articles were studied for any pertinent references and this yielded additional articles. Only articles that directly compared ibuprofen and acetaminophen were eligible for this review.

Data Synthesis:

Eighty-five studies that directly compared ibuprofen to acetaminophen were identified; 54 contained analgesic efficacy data, 35 contained antipyretic/temperature reduction data, and 66 contained safety data (some articles contained more than 1 type of data). Qualitative review of the literature revealed that, for the most part, ibuprofen was more efficacious than acetaminophen for the treatment of pain and fever in both pediatric and adult populations, and that these 2 drugs were equally safe. Meta-analyses on the subset of randomized clinical trial articles that reported sufficient quantitative information to calculate either an odds ratio (adverse event [AE]) or standardized mean difference (pain and fever) confirmed the qualitative results for adult (standardized mean difference [SMD] 0.69; 95% CI 0.57 to 0.81) and pediatric (SMD 0.28; 95% CI 0.10 to 0.46) pain at 2 hours postdose and pediatric fever (SMD 0.26; 95% CI 0.10 to 0.41) at 4 hours postdose. Conclusions regarding adult fever/temperature reduction could not be made due to a lack of evaluable data. The combined odds ratio for the proportion of adult subjects experiencing at least 1 AE slightly favored ibuprofen; however, the difference was not statistically significant (1.12; 95% CI 1.00 to 1.25). No significant difference between drugs in AE incidence was found for pediatric patients (0.82; 95% CI 0.60 to 1.12).

Conclusions:

Ibuprofen is as or more efficacious than acetaminophen for the treatment of pain and fever in adult and pediatric populations and is equally safe.

Resumen

Objetivo:

Evaluar la eficacia y seguridad analgésica y antipirética de ibuprofén y acetaminofén en niños y adultos

Fuentes De Información:

Se realizó una búsqueda de la literatura en los sistemas PubMed/MEDLINE y EMBASE utilizando los términos ibuprofén y acetaminofén. Para esta revisión fueron elegibles sólo los artículos que compararon directamente ibuprofén con acetaminofén.

Síntesis:

Se identificaron 85 estudios, los cuales compararon directamente ibuprofén con acetaminofén; 54 contenían datos de eficacia analgésica, 35 contenían datos en la reducción de temperatura/antipirético, y 66 contenían datos de seguridad (nota: algunos artículos contenían datos de analgesia y/o antipirético y/o seguridad). La revisión cualitativa reveló que ibuprofén fue más eficaz que acetaminofén, en la mayoría de la literatura evaluada en esta revisión, para el tratamiento de dolor y fiebre en ambas poblaciones de pacientes, pediátricos y adultos y que los mismos fueron igualmente seguros. Los meta-análisis de los subgrupos de estudios clínicos aleatorios que reportaron suficiente información cuantitativa para calcular tanto la razón de probabilidad (odds ratio) (eventos adversos) como la diferencia en el promedio estandarizada (dolor y fiebre), confirmó los resultados cualitativos de dolor para adulto (diferencia en promedio estandarizada de 0.69; 95% CI 057 y 0.81) y pediátrico (diferencia en promedio estandarizada de 0.28; 95% CI 0.10 y 0.46) a las 2 horas luego de la dosis y fiebre pediátrica (diferencia en promedio estandarizada de 0.26; 95% CI 0.10 y 0.41) a las 4 horas luego de la dosis. Conclusiones relacionadas a la reducción en temperatura/fiebre en adultos no se pudieron realizar debido a la falta de datos evaluables. La razón de probabilidad combinada para la proporción de sujetos adultos que experimentaron al menos un evento adverso, favoreció levemente a ibuprofén; sin embargo, la diferencia no fue estadísticamente significativa (1.12; 95% CI 1.00 y 1.25). No se encontró diferencia en la incidencia de eventos adversos en pacientes pediátricos (0.82; 95% CI 0.60 y 1.12).

Conclusiones:

Ibuprofén es tan o más eficaz que acetaminofén para el tratamiento del dolor y fiebre en poblaciones adultas y pediátricas e igualmente seguro.

Résumé

Sources De L'Information:

PubMed/MedLINE, et EMBASE, et les articles tirés des bibliographies.

Sélection Des Études Et Extraction Des Données:

Les recherches sur les bases de données PubMed/MedLINE, et EMBASE ont été réalisées avec les mots-clés ibuprofen et acetaminophen. Seuls les articles qui comparaient directement l'ibuprofène et l'acétaminophène étaient éligibles pour cette révision.

Synthèse De L'Information:

Quatre-vingt cinq études comparant directement l'ibuprofène et l'acétaminophène ont été identifiées; 54 contenaient des données sur l'efficacité analgésique, 35 contenaient des données sur l'efficacité antipyrétique, et 66 contenaient des données sur la sécurité (note: certains articles contenaient des données sur l'efficacité analgésique et/ou antipyrétique et/ou la sécurité.) La révision qualitative a révélé que l'ibuprofène est plus efficace que l'acétaminophène dans la plupart des études évaluées dans le traitement de la douleur et de la fièvre, et ce, tant au sein de la population pédiatrique qu'adulte. Cette révision démontre aussi que les 2 médicaments sont également sécuritaires. La méta-analyse réalisée avec le sous-groupe d'études cliniques qui rapportaient suffisamment d'informations quantitatives pour calculer un rapport de cote (réactions indésirables) ou une différence moyenne standardisée (douleur et fièvre), vient confirmer les résultats de l'analyse quantitative chez les adultes (différence moyenne standardisée 0.69; IC 95% 0.57 à 0 81), et chez les enfants (différence moyenne standardisée 0.28, IC 95% 0.10 à 0.46) pour la douleur 2 heures post dose et pour la fièvre en pédiatrie (différence moyenne standardisée 0.26; IC 95% 0.10 à 0.41) 4 heures post dose. Il a été impossible de tirer des conclusions concernant la réduction de la fièvre/température chez les adultes en raison de l'absence de données. Les rapports de cote combinés pour la proportion de sujets adultes qui ont présenté au moins un épisode de réaction indésirable favorise légèrement l'ibuprofène; cependant, cette différence n'était pas statistiquement significative (1.12; IC 95% 1 00 à 1.5). Aucune différence n'a été notée dans la population pédiatrique concernant l'incidence d'effets indésirables (0.82; IC 95% 0.60 à 1.12)

Conclusions:

L'ibuprofène est au moins aussi efficace que l'acétaminophène pour le traitement de la douleur ou de la fièvre chez les adultes ou les enfants et semble tout aussi sécuritaire.

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