PREVENTION OF GASTRODUODENAL DAMAGE WITH OMEPRAZOLE IN PATIENTS RECEIVING CONTINUOUS NSAIDS TREATMENT - A DOUBLE-BLIND PLACEBO-CONTROLLED STUDY

Aim. The aim of this study was to compare omeprazole (20 mg once daily ) with placebo in the long-term prevention of gastroduodenal lesions i nduced by indomethacin, diclofenac and ketoprofen. Patients and method s. 114 patients with arthritic disorders and requiring indomethacin, d iclofenac or ketoprofen were randomized in a double blind manner to re ceive omeprazole - 20 mg once daily - or identical placebo for three w eeks. The gastroduodenal mucosa damage was scored according to a 0-4 p oint endoscopic scale. Results. Of the 114 patients, 103 (50 in the om eprazole group, 53 in the placebo group) were submitted to endoscopy, while 11 patients dropped out for non-medical reasons. At the final en doscopy, 26/57 (46%) of omeprazole group, and 20/57 (35%) of the place bo group had normal gastroduodenal mucosa (score = 0) (p ns; 95% IC -0 .073 +0.284). A gastric ulcer was observed in 7/57 (12%) patients, all in the placebo group (p < 0.01 vs omeprazole); 2 patients (1 in the o meprazole group and 1 in the placebo group) developed a duodenal ulcer : Dyspeptic symptoms developed in 10% of the patients treated with ome prazole and 29% of those receiving placebo (p ns). Conclusions. Omepra zole, 20 mg once daily, provides effective prophylactic therapy in pat ients at risk of developing NSAID-associated gastric and duodenal ulce r.