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.
The researchers aimed to compare risk of gastrointestinal events associated with celecoxib versus diclofenac slow release plus omeprazole. They 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.
They 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. 4484 patients were randomly allocated to treatment (2238 celecoxib; 2246 diclofenac plus omeprazole).
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.
The researchers concluded: "These findings should encourage review of approaches to reduce risk of NSAID treatment."
Fuente: The Lancet published online 17 June 2010