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

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

Predictive factors of mortality from nonvariceal upper gastrointestinal hemorrhage: a multicenter study.

OBJECTIVES: From an Italian Registry of patients with upper gastrointestinal hemorrhage (UGIH), we assessed the clinical outcomes and explored the roles of clinical, endoscopic, and therapeutic factors on 30-day mortality in a real life setting. METHODS: Prospective analysis of consecutive patients endoscoped for UGIH at 23 community and tertiary care institutions from 2003 to 2004. Covariates and outcomes were defined a priori and 30-day follow-up obtained. Logistic regression analysis identified predictors of mortality. RESULTS: One thousand and twenty patients were included. A total of 46 patients died for an overall 4.5% mortality rate. In all, 85% of deaths were associated with one or more major comorbidity. Sixteen of 46 patients (35%) died within the first 24 h of the onset of bleeding. Of these, eight had been categorized as ASA class 1 or 2 and none of them was operated upon, despite a failure of endoscopic intention to treatment in four. Regression analysis showed advanced age, presence of severe comorbidity, low hemoglobin levels at presentation, and worsening health status as the only independent predictors of 30-day mortality (P < 0.001). The acute use of a PPI exerted a protective effect (OR 0.23, 95% CI 0.09-0.73). Recurrent bleeding was low (3.2%). Rebleeders accounted for only 11% of the total patients deceased (OR 3.27, 95% CI 1.5-11.2). CONCLUSIONS: These results indicate that 30-day mortality for nonvariceal bleeding is low. Deaths occurred predominantly in elderly patients with severe comorbidities or those with failure of endoscopic intention to treatment