Prevention of gastroduodenal damage with omeprazole in patients receiving continuous NSAIDs treatment. A double blind placebo controlled study

Abstract

Aim: The aim of this study was to compare omeprazole (20 mg once daily) with placebo in the long-term prevention of gastroduodenal lesions induced by indomethacin, diclofenac and ketoprofen.

Patients and methods: 114 patients with arthritic disorders and requiring indomethacin, diclofenac or ketoprofen were randomized in a double blind manner to receive omeprazole-20 mg once daily- or identical placebo for three weeks. The gastroduodenal mucosa damage was scored according to a 0-4 point endoscopic scale.

Results: Of the 114 patients, 103 (50 in the omeprazole group, 53 in the placebo group) were submitted to endoscopy, while 11 patients dropped out for non-medical reasons. At the final endoscopy, 26/57 (46%) of omeprazole group, and 20/57 (35%) of the placebo 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 omeprazole group and 1 in the placebo group) developed a duodenal ulcer. Dyspeptic symptoms developed in 10% of the patients treated with omeprazole and 29% of those receiving placebo (p ns).

Conclusions: Omeprazole, 20 mg once daily, provides effective prophylactic therapy in patients at risk of developing NSAID-associated gastric and duodenal ulcer.