Multicentre comparative study of two schedules of gabexate mesilate in thetreatment of acute pancreatitis

Aim. To compare the efficacy of two different schedules of gabexate mesilat e (900 mg/day, or 1,500 mg/day) in the treatment of severe acute pancreatit is. Setting. Forty-two Italian medical and surgical centres took part in the st udy. Study design. A multicentre, prospective, open label, comparative, parallel -group, randomized study. Methods. The patients enrolled in the study had acute pancreatitis as demon strated by typical abdominal pain and baseline serum amylase concentrations more than twice the upper normal limit, findings compatible with acute pan creatitis at imaging techniques, and a Glasgow criteria score of greater th an or equal to3. Patients were randomly assigned to one of the two schedule s of treatment with gabexate mesilate being administered intravenously for at least 7 days. The minimum clinically relevant difference (delta), betwee n groups, in incidence of complications due to acute pancreatitis, during t he first month of the study treatment, was predefined as equal to 10%. Results. A total of 199 patients were assigned to gabexate mesilate 900 tre atment and 189 to gabexate mesilate 1,500. Complications developed in 88 pa tients within one month of beginning treatment 44/199: patients (22.1%) in the gabexate mesilate 900 group and 44/489 patients (23.3%) in the gabexate mesilate 1,500 group (difference 1.2%; 95% confidence interval: -7.2, 9.5% ). Conclusions. Gabexate mesilate 900 mg per day is as effective as gabexate m esilate 1500 mg per day in reducing the complications due to acute pancreat itis.