[75 mg roxatidine nocte protects human gastric mucosa against 300 mg acetylsalicylic acid nocte].

In a randomized double-blind parallel study the gastroduodenal tolerability of 300 mg ASS nocte (8 p.m.) has been evaluated in the presence of 75 mg roxatidine nocte (8 p.m.) or placebo in 20 healthy volunteers using upper GI-endoscopy. The treatment periods lasted 14 days. Endoscopic controls were performed at entry, and repeated at day 7 and day 14. At entry the mean endoscopic score averaged 0.9 +/- 0.1 in the ASS/placebo-group and 0.9 +/- 0.1 in the ASS/roxatidine-group. The median values were 1.0 and 1.0. 300 mg ASS nocte induced in the placebo-experiments marked gastroduodenal lesions both at day 7 and day 14 (6.5 +/- 1.2 and 7.9 +/- 0.7, respectively). The median values were 8.0 and 9.0, respectively. Concomitant administration of 75 mg roxatidine nocte afforded significant protection against 300 mg ASS nocte both on day 7 and day 14 (3.3 +/- 1.0 and 3.1 +/- 0.9, respectively) (p less than 0.05). The corresponding median values were 1.0 and 1.0. Our data suggest that coadministration of roxatidine nocte reduces significantly gastroduodenal lesions evoked by acetylsalicylic acid 300 mg nocte.