The clinical efficacy and gastroduodenal tolerability of
imidazole salicylate (
imidazole 2-hydroxybenzoate,
ITF 182), a new
synthetic drug with an anti-inflammatory action, was evaluated endoscopically in comparison with those of
piroxicam in elderly patients suffering from
osteoarthrosis. Of the 41 patients entering the trial, only 38 completed the protocol (6 men and 32 women; mean age, 71; range, 65-80 years). After upper gastrointestinal endoscopy for the purpose of excluding gastric and duodenal mucosal lesions, the patients were allocated at random, according to a double-blind, double-dummy protocol, to treatment either with
imidazole salicylate 750 mg three times daily or with
piroxicam 20 mg once daily for a period of 4 weeks.
Imidazole salicylate proved active in controlling a number of the
pain symptoms caused by
arthrosis, although its efficacy was inferior to that of
piroxicam. Grade 2 gastric mucosal lesions were detected in 1 of 20 patients (5%) treated with
imidazole salicylate; lesions corresponding to grades 2, 3, and 4 were found in 6 of 18 (33%) of those treated with
piroxicam (P = .034). Painful
dyspepsia was reported by 15% of the patients in the
imidazole salicylate group and by 28% of those in the
piroxicam group. On the basis of these results and under the experimental conditions adopted in this trial, the authors concluded that
imidazole salicylate is characterized by good gastric tolerability and can thus be used in the treatment of
rheumatic diseases in the elderly.(ABSTRACT TRUNCATED AT 250 WORDS)