An open, prospective, randomized, 6-month, clinical trial was performed on 198 patients with healed duodenal ulcers (DUs) to compare three omeprazole schedules for the prevention of ulcer relapse - 20 mg daily (group 1), 20 mg every other day (group 2), and 40 mg on Saturday and Sunday (group 3). Patients were followed up at 3-month intervals; endoscopy and laboratory screening (including basal serum gastrin measurement) were performed at baseline, after 6 months, and in the event of any symptomatic relapse. One-way analysis of variance, the chi-square test, and Student's t test on paired data were used for statistical analysis of the study data. Per protocol analysis (PPa) and a more restrictive analysis (Ra) considering all dropouts as treatment failures were also used. Patients were randomly assigned to one of three treatment groups: 67 to group 1, 69 to group 2, and 62 to group 3. Thirty-two patients dropped out of the study, 14 in group 1, 3 in group 2, and 15 in group 3. Confirmed ulcer relapse rates were 3.8% in group 1, 19.7% in group 2, and 23.4% in group 3 (PPa, P < 0.01). Ra rates were 23.9%, 23.2%, and 41.9%, respectively (P < 0.03). No severe side effects were recorded. Over a 6-month period, omeprazole 20 mg daily appeared to be the most effective maintenance treatment for healed DU. All three omeprazole schedules were well tolerated.
Omeprazole in the maintenance treatment of duodenal ulcer: Results after 6 months of 20 mg daily, 20 mg every other day, or 40 mg on weekends / Di Mario, Francesco; Battaglia, Giuseppe; De Boni, Michele; De Bona, Emanuela; Leandro, Gioacchino; Chiozzini, Giorgio; Pasini, Michele; Grasso, Giovanni Andrea; Ferrana, Marina; Saggioro, Alfredo; Pasquino, Marcello. - In: CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL. - ISSN 0011-393X. - 57:1(1996), pp. 33-41. [10.1016/S0011-393X(96)80027-0]
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