RESEARCH - Celecoxib versus omeprazole and diclofenac in patients with OA and RA: CONDOR

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Lancet. 2010 Jul 17;376(9736):173-9. Epub 2010 Jun 16.

Celecoxib versus omeprazole and diclofenac in patients with

osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial.

Chan FK, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL.

Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong SAR, China.

Abstract

BACKGROUND: Cyclo-oxygenase (COX)-2-selective non-steroidal

anti-inflammatory drugs (NSAIDs) and non-selective NSAIDs plus a

proton-pump inhibitor (PPI) have similar upper gastrointestinal

outcomes, but risk of clinical outcomes across the entire

gastrointestinal tract might be lower with selective drugs than with

non-selective drugs. We aimed to compare risk of gastrointestinal

events associated with celecoxib versus diclofenac slow release plus

omeprazole.

METHODS: We undertook a 6-month, double-blind, randomised trial in

patients with osteoarthritis or rheumatoid arthritis at increased

gastrointestinal risk at 196 centres in 32 countries or territories.

Patients tested negative for Helicobacter pylori and were aged 60

years and older or 18 years and older with previous gastroduodenal

ulceration. We used a computer-generated randomisation schedule to

assign patients in a 1:1 ratio to receive celecoxib 200 mg twice a day

or diclofenac slow release 75 mg twice a day plus omeprazole 20 mg

once a day. Patients and investigators were masked to treatment

allocation. The primary endpoint was a composite of clinically

significant upper or lower gastrointestinal events adjudicated by an

independent committee. Analysis was by intention to treat. This trial

is registered with ClinicalTrials.gov, number NCT00141102.

FINDINGS: 4484 patients were randomly allocated to treatment (2238

celecoxib; 2246 diclofenac plus omeprazole) and were included in

intention-to-treat analyses. 20 (0.9%) patients receiving celecoxib

and 81 (3.8%) receiving diclofenac plus omeprazole met criteria for

the primary endpoint (hazard ratio 4.3, 95% CI 2.6-7.0; p<0.0001). 114

(6%) patients taking celecoxib versus 167 (8%) taking diclofenac plus

omeprazole withdrew early because of gastrointestinal adverse events

(p=0.0006).

INTERPRETATION: Risk of clinical outcomes throughout the

gastrointestinal tract was lower in patients treated with a

COX-2-selective NSAID than in those receiving a non-selective NSAID

plus a PPI. These findings should encourage review of approaches to

reduce risk of NSAID treatment.

FUNDING: Pfizer Inc. Copyright 2010 Elsevier Ltd. All rights reserved.

PMID: 20638563

http://www.ncbi.nlm.nih.gov/pubmed/20638563

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