Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials

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dc.contributor.authorKearney, Patricia M.
dc.contributor.authorBaigent, C.
dc.contributor.authorGodwin, Jon
dc.contributor.authorHalls, H.
dc.contributor.authorEmberson, J. R.
dc.contributor.authorPatrono, C.
dc.contributor.funderEuropean Commissionen
dc.contributor.funderMedical Research Council, United Kingdomen
dc.contributor.funderThe Clinical Trial Service Unit (CTSU), United Kingdomen
dc.contributor.funderBritish Heart Foundation, United Kingdomen
dc.contributor.funderCancer Research UKen
dc.contributor.funderMinistry of University and Research, Italyen
dc.date.accessioned2016-07-13T08:46:11Z
dc.date.available2016-07-13T08:46:11Z
dc.date.issued2006-06-01
dc.date.updated2013-11-28T15:11:48Z
dc.description.abstractObjective: To assess the effects of selective cyclo-oxygenase-2 (COX 2) inhibitors and traditional non-steroidal anti-inflammatory drugs (NSAIDs) on the risk of vascular events. Design: Meta-analysis of published and unpublished tabular data from randomised trials, with indirect estimation of the effects of traditional NSAIDs. Data sources: Medline and Embase (January 1966 to April 2005); Food and Drug Administration records; and data on file from Novartis, Pfizer, and Merck. Review methods: Eligible studies were randomised trials that included a comparison of a selective COX 2 inhibitor versus placebo or a selective COX 2 inhibitor versus a traditional NSAID, of at least four weeks' duration, with information on serious vascular events (defined as myocardial infarction, stroke, or vascular death). Individual investigators and manufacturers provided information on the number of patients randomised, numbers of vascular events, and the person time of follow-up for each randomised group. Results: In placebo comparisons, allocation to a selective COX 2 inhibitor was associated with a 42% relative increase in the incidence of serious vascular events (1.2%/year v 0.9%/year; rate ratio 1.42, 95% confidence interval 1.13 to 1.78; P = 0.003), with no significant heterogeneity among the different selective COX 2 inhibitors. This was chiefly attributable to an increased risk of myocardial infarction (0.6%/year v 0.3%/year; 1.86, 1.33 to 2.59; P = 0.0003), with little apparent difference in other vascular outcomes. Among trials of at least one year's duration (mean 2.7 years), the rate ratio for vascular events was 1.45 (1.12 to 1.89; P = 0.005). Overall, the incidence of serious vascular events was similar between a selective COX 2 inhibitor and any traditional NSAID (1.0%/year v 0.9/%year; 1.16, 0.97 to 1.38; P = 0.1). However, statistical heterogeneity (P = 0.001) was found between trials of a selective COX 2 inhibitor versus naproxen (1.57, 1.21 to 2.03) and of a selective COX 2 inhibitor versus non-naproxen NSAIDs (0.88, 0.69 to 1.12). The summary rate ratio for vascular events, compared with placebo, was 0.92 (0.67 to 1.26) for naproxen, 1.51 (0.96 to 2.37) for ibuprofen, and 1.63 (1.12 to 2.37) for diclofenac. Conclusions: Selective COX 2 inhibitors are associated with a moderate increase in the risk of vascular events, as are high dose regimens of ibuprofen and diclofenac, but high dose naproxen is not associated with such an excess.en
dc.description.sponsorshipMedical Research Council, UK; British Heart Foundation; Cancer Research UK; Italian Ministry of University and Research (Center of Excellence on Aging of the “G d’Annunzio” University Foundation); European Commission (EICOSANOX Project 005033).en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationKearney P. M., Baigent C., Godwin J., Halls H., Emberson J. R. and Patrono C. (2006) 'Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials', BMJ, 332(7553) pp. 1302-1308. http://www.bmj.com/content/bmj/332/7553/1302.full.pdfen
dc.identifier.doi10.1136/bmj.332.7553.1302
dc.identifier.endpage1308en
dc.identifier.issn0959-8138
dc.identifier.issn1756-1833
dc.identifier.issued7553en
dc.identifier.journaltitleBMJ (Clinical Research Ed.)en
dc.identifier.startpage1302en
dc.identifier.urihttps://hdl.handle.net/10468/2862
dc.identifier.volume332en
dc.language.isoenen
dc.publisherBMJ Publishing Groupen
dc.rights© 2006, the authorsen
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectCelecoxiben
dc.subjectCyclooxygenase 2 inhibitoren
dc.subjectDiclofenacen
dc.subjectibuprofenen
dc.subjectAnti-inflammatory agentsen
dc.subjectNon-Steroidalen
dc.subjectAtherosclerosisen
dc.subjectThrombosisen
dc.titleDo selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trialsen
dc.typeArticle (peer-reviewed)en
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