RESEARCH - Upper GI adverse drug reactions and COX-2s (Celebrex and Vioxx)

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Eur J Clin Pharmacol. 2004 Nov;60(9):673-7. Epub 2004 Oct 23.

Upper gastrointestinal adverse drug reactions and cyclo-oxygenase-2

inhibitors (celecoxib and rofecoxib): a case/non-case study from the French

Pharmacovigilance Database.

Lugardon S, Lapeyre-Mestre M, Montastruc JL.

Service de Pharmacologie Clinique, Centre Midi-Pyrenees de

Pharmacovigilance, de Pharmacoepidemiologie et d'Information sur le

Medicament, Unite de Pharmacoepidemiologie, EA 3696, IFR 126, Faculte de

Medecine, Toulouse, France.

OBJECTIVE: To evaluate the gastrointestinal safety of cyclo-oxygenase-2

inhibitors under their real conditions of use. DESIGN. Case/non-case study.

SETTING: Adverse drug reactions (ADRs) in adults recorded in the French

Pharmacovigilance Database between 25 May 2000 and 31 December 2002.

MATERIALS: Cases were all reports of " serious " oeso-gastro-duodenal ADRs

(oeso-gastro-duodenal ulcers, oesophagitis, gastritis, duodenitis). Five

non-cases were randomly selected for one case from all other non

oeso-gastro-duodenal reports in the database after matching them for age,

gender and period of occurrence. ANALYSIS: ib exposure was compared among

cases and non-cases, with adjustment for matching factors: French Regional

Pharmacovigilance Centres that collected ADRs, reporter health

professional's characteristics and exposures to non-selective non-steroidal

anti-inflammatory, aspirin, anticoagulant, antiplatelet and gastroprotective

drugs. RESULTS: Included in the study were 505 cases and 2,525 non-cases. A

positive association was found between occurrence of oeso-gastro-duodenal

ADRs and coxib (adjusted odds ratio 14.9 [95% CI 9.3-23.7]), diclofenac (9.2

[3.8-22.2]), ibuprofen (7.3 [3.2-16.6]) or oxicam (25.3 [11.9-53.6]) use.

CONCLUSION: Despite the compulsory limits of the case/non-case methodology,

the present study shows that coxibs did induce " serious " gastrointestinal

ADRs in real clinical practice. These results underline the need for

pharmacoepidemiological studies under real conditions of use in order to

verify (or not) the conclusions of clinical trials.

PMID: 15517227

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=15517227

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