Reduction of indomethacin induced gastroduodenal mucosal injury and gastrointestinal symptoms with cimetidine in normal subjects.
A study was performed in 57 healthy volunteers to determine the effectiveness of cimetidine on reducing gastrointestinal (GI) mucosal lesions and symptoms induced by indomethacin. Endoscopic evidence of gastroduodenal injury and various GI symptoms appeared within 4 days after initiation of indomethacin therapy (50 mg TID) alone. Concomitant therapy with cimetidine, either 200 mg QID or 400 mg BID reduced the incidence of gastric erosions by up to 25% and duodenal erosions by up to 44% (gastric erosions from 81 to 61 and 78%, and duodenal erosions from 90 to 50 and 61%). The incidence of gastric ulcers was reduced from 24 to 0 and 6%, and of duodenal ulcers from 14 to 0 and 11%). The occurrence of moderate or severe pain was also significantly less with coadministration of cimetidine. Results from our study suggest that cimetidine may provide an effective prophylactic therapy against both NSAID related symptoms and gastroduodenal mucosal lesions.
Frank
W O
WO
Department of Clinical Development, North America, Smith Kline and French Laboratories, Philadelphia, PA 19101.
Wallin
B A
BA
Berkowitz
J M
JM
Kimmey
M B
MB
Palmer
R H
RH
Rockhold
F
F
Young
M D
MD
D000293:Adolescent; D000328:Adult; D002927:Cimetidine / Q000008:administration & dosage / Q000494:pharmacology*; D004064:Digestive System / Q000187:drug effects* / Q000293:injuries; D004381:Duodenal Ulcer / Q000517:prevention & control; D004386:Duodenum / Q000187:drug effects / Q000293:injuries; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects / Q000293:injuries; D006801:Humans; D007213:Indomethacin / Q000009:adverse effects / Q000037:antagonists & inhibitors*; D007413:Intestinal Mucosa / Q000187:drug effects / Q000293:injuries; D008297:Male; D013276:Stomach Ulcer / Q000517:prevention & control
D002927:Cimetidine; D007213:Indomethacin