Antisecretory effects of three omeprazole regimens for maintenance treatment in duodenal ulcer.

This study was carried out to assess the antisecretory effects and their possible changes over time of three different dose regimens of omeprazole that could be proposed for maintenance treatment in duodenal ulcer. Forty-five patients with endoscopically proven duodenal ulcer were studied by means of 24-hr gastric pH-metry both in basal conditions and on the fifth day of acute treatment with omeprazole 20 mg in the morning. Ulcers healed after four weeks (in three cases after eight weeks) and afterwards, 15 patients were randomized to receive orally at 0800 hr in single-blind fashion omeprazole 10 mg daily (group A), 15 to receive omeprazole 40 mg on Saturday and Sunday followed by a five-day period without medication (group B), and 15 to receive omeprazole 20 mg every other day (group C) for up to three months. On the 20th and 80th days of these maintenance treatments 24-hr gastric pH-metry was repeated to assess the antisecretory effectiveness of each regimen over a two-month period. In patients of group B these tests began at 1700 hr on Friday, the last of five days off treatment, and in those of group C at 1700 hr of the day off medication. All three dose regimens of omeprazole were able to raise pH values significantly (P < 0.01-0.001) compared to basal levels. Omeprazole 20 mg every other day was more effective (P < 0.01) than omeprazole 40 mg weekend, but did not differ significantly from omeprazole 10 mg daily. The durations of acid inhibition (pH > 3.0 units/24 hr) were 12.44, 10.00, and 17.38 hr with groups A, B, and C, respectively. There was no significant difference between the pH profiles of the 20th and 80th days with every dose regimen. It is concluded that all three dose regimens of omeprazole are effective in reducing gastric acidity and their pharmacodynamic action does not change with time. Therefore they are suitable to be assessed in large clinical trials aimed at verifying the prevention of duodenal ulcer recurrence for longer periods.

RCT Entities:   Population Interventions Outcomes