CONDOR trial finds raised GI risk for diclofenac + omeprazole
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CONDOR trial finds raised GI risk for diclofenac + omeprazole Researchers for the multinational CONDOR* trial found the rate of clinically significant GI events to be four times higher in patients receiving diclofenac plus omeprazole than in those receiving celecoxib.1 The trial involved 4484 patients with osteoarthritis or rheumatoid arthritis who were randomised to receive either celecoxib 200mg twice daily (n = 2238) or diclofenac slow release 75mg twice daily plus omeprazole 20mg once daily for about 6 months. Overall, 20 patients (0 9%) receiving celecoxib and 81 (3 8%) receiving diclofenac plus omeprazole met criteria for the primary endpoint of a composite of clinically significant upper or lower GI events adjudicated by an independent committee (HR 4.3, 95% CI 2.6, 7.0; p < 0 0001). However, the researchers note that rates of upper GI bleeding did not differ between the treatment groups. In an accompanying editorial, Elham Rahme and Sasha Bernatsky from McGill University Health Centre, Montreal, Canada, contend that, as the rate of serious upper GI bleeds was similar between groups, the lower GI risk associated with celecoxib in the trial "was mainly attributable to the difference between treatment groups in haemoglobin decrease", not by documented lower GI bleeds.2
Cardiovascular events worth noting? They also point out that, while abdominal symptoms were slightly less frequent with celecoxib (16%) than with diclofenac plus omeprazole (19%), the risk of serious adverse events was similar in both groups (3%), with 21 serious adverse cardiovascular events confirmed. However, Rahme and Bernatsky do acknowledge the CONDOR researchers statement that "the cardiovascular data should be interpreted with caution because they might not show the true cardiovascular hazard of the two treatments". * Celecoxib versus Omeprazole and Diclofenac in patients with Osteoarthritis and Rheumatoid arthritis; sponsored by Pfizer 1. Chan FKL, et al. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet : [7 pages], 17 Jun 2010. Available from: URL: www.thelancet.com. 2. Rahme E, et al. NSAIDs and risk of lower gastrointestinal bleeding. Lancet : [2 pages], 17 Jun 2010. Available from: URL: http://dx.doi.org/10.1016/ S0140-6736(10)60839-2. 801140617
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Reactions 26 Jun 2010 No. 1307
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