GI tract

COX-2 inhibitors retains GI benefits with concomitant aspirin use

Celecoxib loses some of its safety advantages over non-selective NSAIDs when taken concomitantly with aspirin, a retrospective analysis of almost 24,000 patients with arthritis shows.

When used without aspirin, a low daily dose (200mg) of the COX-2 selective inhibitor had a more favourable overall safety profile than ibuprofen and naproxen, a review of data from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen) study found.

However, when taken concomitantly with aspirin, rates of cardiovascular events were generally similar between celecoxib, ibuprofen and naproxen. The selective COX-2 inhibitor continued to be associated with fewer gastro-intestinal events than both the non-selective NSAIDs and fewer renal events than ibuprofen.

The results were from a sub-study of outcomes in 23953 patients with pre-existing heart disease or increased risk for developing heart disease taking daily NSAIDs for OA or RA a minimum of 18 months. About 11,000 of the patients were also taking lower doses (less than 325mg) of aspirin.

The study authors said the results were important for clinical practice because of the large number of patients taking both aspirin and NSAIDs on a regular basis.

“If a patient is not on aspirin, these results suggest that in many cases, celecoxib may be the NSAID of choice,” said Dr Grant Reed, a cardiologist at the Cleveland Clinic, and the study’s first author.

“Our findings underscore how important it is that physicians counsel their patients when starting them on an NSAID and consider the potential effects of use together with aspirin,” he added

The Pfizer-funded PRECISION trial was set up in response to the withdrawal of rofecoxib (Vioxx) in 2004 due to high rates of cardiovascular events. It showed that celecoxib was not more risky than ibuprofen or naproxen.

The authors said the new analysis also supported the hypothesis that the increased cardiovascular risk seen with rofecoxib was not a class effect of the coxibs.

“Furthermore, our results suggest that celecoxib has a more favourable cardiovascular safety profile than ibuprofen or naproxen among patients not on aspirin and that the cardiovascular safety profile of celecoxib is noninferior to ibuprofen or naproxen among aspirin users,” they concluded in the Journal of the American College of Cardiology.

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