Cimetidine tablets or suspension for the prevention of gastrointestinal mucosal lesions caused by non-steroidal, anti-inflammatory drugs.
We compared the protection offered by cimetidine 400 mg b.i.d. as tablets or suspension vs. placebo, in Naproxen-induced gastrointestinal damage in 17 healthy males. Upper endoscopy was performed before and after each drug period, with separate evaluation of duodenal mucosa distal to the duodenal bulb. 51Cr-EDTA absorption tests were done to assess distal mucosal integrity, and symptoms were registered. All regimens caused a significant increase in mucosal damage (p less than 0.01). Cimetidine tablets gave a significantly lower damage score than placebo for gastritis/duodenitis and hemorrhagic lesions in the stomach/duodenal bulb, and for the sum of scores in both scoring regions (p = 0.02). Cimetidine suspension was not significantly different from placebo for any of the endoscopic parameters. The 51Cr-EDTA absorption was significantly increased after all drug periods. However, there was no difference between the three drug combinations. Symptoms reported were mild and equal in the three groups. Cimetidine tablets offered protection against Naproxen-induced mucosal damage, primarily in the stomach and duodenal bulb, but lacked any effect on permeability changes. Cimetidine suspension was not significantly different from placebo in any respect.
Aabakken
L
L
Medical Dept., Ullevål Hospital, Oslo, Norway.
Larsen
S
S
Osnes
M
M
D000042:Absorption; D000328:Adult; D002860:Chromium Radioisotopes; D002927:Cimetidine / Q000008:administration & dosage* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004386:Duodenum / Q000187:drug effects / Q000473:pathology; D004492:Edetic Acid; D004724:Endoscopy; D005753:Gastric Mucosa / Q000187:drug effects* / Q000378:metabolism / Q000473:pathology; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects; D007413:Intestinal Mucosa / Q000187:drug effects* / Q000473:pathology; D008297:Male; D009288:Naproxen / Q000009:adverse effects*; D013535:Suspensions; D013607:Tablets
D002860:Chromium Radioisotopes; D013535:Suspensions; D013607:Tablets; D009288:Naproxen; D002927:Cimetidine; D004492:Edetic Acid