Comparison of the effects of etodolac SR and naproxen on gastro-intestinal blood loss

Summary

A single-blind, open-label controlled study was carried out in 30 healthy male volunteers to compare gastro-intestinal blood loss before, during and after treatment with a new, sustained-release formulation of the non-steroidal anti-inflammatory agent etodolac (etodolac SR) or with naproxen. Subjects remained at the study centre for 21 days and received placebo twice daily from Days 1 to 7 after which they were assigned at random to receive etodolac SR either as a single 600 mg or 1200 mg daily dose or naproxen (500 mg twice daily) for 7 days and then placebo again until the end of the study. There were 10 subjects in each of the three treatment groups. Gastro-intestinal blood loss was measured by the Cr-tagged erythrocyte method and was averaged for Days 4 to 7 (pre-treatment baseline), Days 11 to 14 (treatment period), and Days 17 to 20 (post-treatment period). The mean daily gastro-intestinal blood loss during the treatment period was significantly greater for the naproxen-treated group (1.20 ml/day) than for the 600 mg etodolac SR group (0.38 ml/day) and the 1200 mg etodolac SR group (0.45 ml/day). These results show that etodolac SR in doses of 600 mg and 1200 mg/day causes significantly less gastro-intestinal blood loss than does naproxen 500 mg twice daily.

Key Words::

• Etodolac
• naproxen
• anti-inflammatory agents
• non-steroidal
• dosage forms
• occult blood