Reduction of aspirin-induced fecal blood loss with low-dose misoprostol tablets in man

Abstract

Misoprostol (SC-29333), a synthetic prostaglandin E₁ methyl ester analog, was given simultaneously with acetylsalicylic acid in a double-blind, placebo-controlled randomized prospective study of 32 healthy human male subjects. Fecal blood loss was measured for eight days using the⁵¹Cr-labeled red blood cell technique. Aspirin (650 mg qid) and misoprostol (25 μg qid) or placebo were given during days 3, 4, and 5. There was a significant (PN=16). Median blood loss was increased (from 0.75 to 3.75 ml/day) in the aspirin with misoprostol group (N=16), but this was significantly less (Mann-Whitney U test,P<0.01) than the placebo group. Mean serum salicylate concentrations in the placebo and misoprostol groups were similar (7.8 and 6.8 μg/ml, respectively). There were no significant changes in laboratory values in any of the subjects studied, nor were any major side-effects encountered. This study demonstrates that oral misoprostol reduces aspirin-induced gastrointestinal bleeding even when administered simultaneously and at a dose level below its threshold for significant acid inhibition. This indicates a potential role for misoprostol in the prevention of gastric mucosal damage in selected patients.