Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and
rheumatoid arthritis (CONDOR): a randomised trial.
Author(s): Chan FK, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL.
Affiliation(s): Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong SAR, China.
fklchan@cuhk.edu.hk
Publication date & source: 2010, Lancet. , 376(9736):173-9
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.
Erratum in
Lancet. 2011 Jul 16;378(9787):228.
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