Comparative study of the safety and efficacy of ebrotidine versus ranitidine and placebo in the prevention of piroxicam-induced gastroduodenal lesions.

This study assessed the efficacy of ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]-4-thiazolyl] methyl]thio]ethyl]amino]methylene]-4-bromo-benzenesulfonamide, CAS 100981-43-9, FI-3542) versus ranitidine and placebo in preventing gastroduodenal lesions induced by piroxicam. Thirty patients with rheumatic disease, who were divided into 5 groups, received an oral treatment of piroxicam 20 mg once daily for 6 days plus ebrotidine 400 mg/day (Group I); ebrotidine 800 mg/day (Group II); ranitidine 150 mg/day (Group III); ranitidine 300 mg/day (Group IV); or placebo (Group V). Patients were endoscopically examined before and after treatment. Lanza's score was also determined, and laboratory tests were performed. The results of this study showed that the most powerful protective effect against mucosal gastric lesions induced by piroxicam was achieved with 800 mg/day of ebrotidine. Ranitidine at doses of 150 mg/day did not protect gastric mucosa, and the 300 mg/day dose exerted a poor gastroprotective effect.