Upper gastrointestinal safety with nabumetone.

Nabumetone is a nonacidic nonsteroidal antiinflammatory drug (NSAID) that is effective and appears to cause minimal NSAID gastropathy. The lack of significant untoward gastrointestinal (GI) effects has been demonstrated in large and longterm clinical experiences. The United States Food and Drug Administration reports an annual ulcer incidence of 2 to 4% with chronic NSAID use. The ulcer incidence after therapy with nabumetone, however, is far below the reported range. Only 1 (0.1%) ulcer in 930 patients was determined clinically in United States short term (6-week to 6-month) double blind studies. Additionally, in the long-term (8-year), open label study, only 16 (0.95%) ulcers occurred in 1677 patients. Endoscopically determined ulcers, on the other hand, occur in about 20% of chronic NSAID users. In our short term (3-month) and longterm (5-year) endoscopically controlled study, a 5% (1 of 19 patients) ulcer incidence was determined. Overall, these results suggest a significantly reduced rate of ulcer development.