A randomized trial measuring fecal blood loss after treatment with rofecoxib, ibuprofen, or placebo in healthy subjects

PURPOSE: Gastrointestinal microbleeding, as assessed by the measurement of (51)chromium-labeled red blood cells, is a marker of the mucosal injury ass ociated with the use of nonsteroidal anti-inflammatory drugs. This study te sted the hypotheses that cyclooxygenase-2 specific inhibition with rofecoxi b would cause less fecal blood loss than a therapeutic dose of ibuprofen an d would be equivalent to placebo. SUBJECTS AND METHODS: In this randomized, double-blind group study, gastroi ntestinal blood loss was assessed by measurement of fecal (51)chromium radi oactivity during a 1-week placebo baseline period and during 4 weeks of tre atment with rofecoxib) (25 mg or 50 mg once daily), ibuprofen (800 mg three times daily), or placebo in 67 healthy subjects. Gastrointestinal blood lo ss during treatment weeks 2 to 4 (versus the baseline period) was expressed as the geometric mean ratio of fecal radioactivity in weeks 2 to 4 compare d with baseline. RESULTS: Ibuprofen caused significantly (P <0.001) greater gastrointestinal blood loss (geometric mean ratio of 5.2, 95% confidence interval [CI]: 4.2 to 6.3) than the 25-mg dose of rofecoxib (2.6, 95% CI: 2.2 to 3.1), the 50 -mg dose of rofecoxib (2.6, 95% CI: 2.2 to 3.0), or placebo (2.1, 95% CI: 1 .8 to 2.5). In contrast, gastrointestinal blood loss with both doses of rof ecoxib were equivalent to placebo by a predetermined clinical similarity bo und. CONCLUSIONS: In healthy subjects, treatment with rofecoxib, at 2 to 4 times the doses that are currently recommended for the treatment of patients wit h osteoarthritis, produced significantly less fecal blood loss than a thera peutic dose of ibuprofen and was equivalent to placebo. (C) 2000 by Excerpt a Medica, Inc.