medwireNews: Results of the CONCERN trial suggest that celecoxib is associated with a lower risk for recurrent upper gastrointestinal (GI) bleeding than naproxen among patients with arthritis and cardiothrombotic diseases treated concomitantly with aspirin and non-steroidal anti-inflammatory drugs (NSAIDs).
“Present guidelines have provided conflicting recommendations” for this patient group, study author Francis Chan (The Chinese University of Hong Kong) and colleagues write in The Lancet.
“Development of an [optimal] management strategy for patients with arthritis and at high risk of both cardiovascular and gastrointestinal events is crucial in our ageing global population,” they add.
In the CONCERN (Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients) study, patients who had experienced upper GI bleeding were randomly assigned to receive either the cyclooxygenase-2-selective NSAID celecoxib 100 mg twice daily or the non-selective NSAID naproxen 500 mg twice daily after ulcer healing. In both cases, NSAIDs were taken alongside the proton pump inhibitor esomeprazole at a dose of 20 mg/day, and all participants were advised to resume taking aspirin 80 mg every day.
Recurrent upper GI bleeding occurred in 14 of 256 participants receiving celecoxib and 31 of 256 patients in the naproxen group over a median follow-up of 18 months, translating into a significantly lower cumulative incidence of bleeding among those receiving celecoxib, at 5.6% versus 12.3%.
A similar proportion of patients in each group discontinued treatment due to adverse events (8.0 vs 7.0%), and there was no significant difference in the incidence of serious cardiovascular events between the two groups (4.4 vs 5.5%). However, the researchers caution that the study “was not powered to assess the cardiovascular safety of NSAIDs.”
While Chan and colleagues say that their findings “address the major unmet need in the present guidelines,” the authors of an accompanying comment believe that “the trial adds modestly to the body of knowledge on the benefit–risk balance of NSAID use, albeit for a very select population of patients.”
Patricia McGettigan (Queen Mary University of London, UK) and Anne-Marie Schjerning Olsen (Copenhagen University Hospital Herlev and Gentofte, Denmark) explain: “The trial’s lost opportunity to fully inform guidelines is its failure to include a non-NSAID treatment group.”
Patients, healthcare providers, and guideline writers are therefore “left to make a lesser of two evils recommendation as opposed to knowing the excess risk of either NSAID over simple analgesia,” they add.
Chan and team agree that “[a]voidance of all NSAIDs will be the safest approach in these high-risk patients,” but recommend that “in patients who continue to require concomitant NSAIDs and aspirin, celecoxib plus a proton-pump inhibitor encompass the least risk of recurrent upper gastrointestinal bleeding.”
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