PARIS — Celecoxib plus a proton pump inhibitor is the superior gastroprotective strategy in patients who require chronic NSAID therapy for analgesia but have had a prior NSAID-associated bleeding ulcer, according to a randomized clinical trial.
The 13-month cumulative incidence of recurrent ulcer bleeding in this trial was 0% in subjects randomized to the combination therapy, compared with 8.9% in controls on celecoxib (Celebrex) plus placebo, Dr. Francis K. Chan said at a satellite symposium held in conjunction with the annual European Congress of Rheumatology.
The study participants were a consecutive series of 441 Helicobacter pylori-negative Hong Kong arthritis patients taking nonselective NSAIDS until they were hospitalized for upper GI ulcer bleeding. Randomization to celecoxib 200 mg plus esomeprazole (Nexium) 20 mg, both twice daily, or to celecoxib plus placebo took place after their ulcers healed, explained Dr. Chan, professor of medicine and chief of gastroenterology and hepatology at the Chinese University of Hong Kong.
He observed that, for those physicians who dismiss clinical trials as not reflecting real-world practice, it's worth noting that a marked reduction in the risk of recurrent upper GI bleeding with the combination of celecoxib and a proton pump inhibitor (PPI) also was documented in a recent case-control study by Dr. Laura L. Targownik and her coworkers at the University of Manitoba, Winnipeg.
The Canadians matched 1,382 patients hospitalized for NSAID-associated upper GI complications to nearly 34,000 controls. They concluded that the combination of celecoxib and a PPI provided gastroprotection superior to a nonselective NSAID plus a PPI, a cyclooxygenase-2 inhibitor alone, or a nonselective NSAID plus misoprostol (Gastroenterology 2008;134:937-44).
Results of the Canadian study along with Dr. Chan's published clinical trial (Lancet 2007;369:1621-6) suggest a need to revisit current American College of Rheumatology guidelines for the management of osteoarthritis. The guidelines recommend use of a COX-2 inhibitor or nonselective NSAID plus a PPI in patients at increased risk of ulcers, but these recent studies clearly show that is not adequate protection for the substantial group at very high risk, according to Dr. Chan.
The satellite symposium was supported by Pfizer Inc. Dr. Chan's study was solely supported by the Research Grants Council of Hong Kong, while Dr. Targownik's was supported by the Canadian Institutes of Health Research and the Manitoba Medical Services Foundation. Dr. Chan has received consulting fees from Pfizer.