Clinical development programme for omeprazole.

Abstract

Omeprazole has been shown to provide more rapid symptom relief and to heal ulcers more quickly and reliably than H2-receptor antagonists in duodenal ulcer, gastric ulcer and reflux oesophagitis. In addition, omeprazole is well tolerated and has a good safety profile. Among the areas for clinical development with omeprazole are the maintenance treatment of duodenal ulcer, treatment of non-steroidal anti-inflammatory drugs (NSAID)-induced gastro-duodenal lesions, maintenance treatment of reflux oesophagitis and the treatment of bleeding ulcer. Two studies of patients with duodenal ulcer have shown that maintenance treatment with omeprazole, 10 mg once daily, was as effective as, or superior to, treatment with omeprazole, 20 mg given on Friday, Saturday and Sunday only, and markedly superior to placebo. In patients with gastric ulcer which developed during treatment with NSAIDs omeprazole, 20 mg once daily, resulted in a higher healing rate than ranitidine, 150 mg b.i.d., both at 4 and at 8 weeks. Reflux oesophagitis is often a persistent condition requiring continuous maintenance treatment. In a recent multicentre trial, a substantially higher proportion of patients remained in remission with omeprazole, 20 mg once daily, than with ranitidine, 150 mg b.i.d. Studies comparing omeprazole and ranitidine (administered intravenously) in patients with bleeding peptic ulcers have also demonstrated the superiority of omeprazole with regard to the control of bleeding and the avoidance of surgery. Further studies are currently underway in this and other related areas.