Reduction of aspirin-induced fecal blood loss with low-dose misoprostol tablets in man.
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 the 51Cr-labeled red blood cell technique. Aspirin (650 mg qid) and misoprostol (25 micrograms qid) or placebo were given during days 3, 4, and 5. There was a significant (P less than 0.05) increase in median blood loss (modified Friedman test) from 0.81 to 6.05 ml/day in the aspirin with placebo group (N = 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 less than 0.01) than the placebo group. Mean serum salicylate concentrations in the placebo and misoprostol groups were similar (7.8 and 6.8 micrograms/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.
D000328:Adult; D001241:Aspirin / Q000009:adverse effects / Q000037:antagonists & inhibitors*; D002860:Chromium Radioisotopes; D004311:Double-Blind Method; D004341:Drug Evaluation; D005243:Feces / Q000032:analysis; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced / Q000517:prevention & control*; D006801:Humans; D008297:Male; D016595:Misoprostol; D011459:Prostaglandins E, Synthetic / Q000627:therapeutic use*; D011897:Random Allocation
D002860:Chromium Radioisotopes; D011459:Prostaglandins E, Synthetic; D016595:Misoprostol; D001241:Aspirin