R Pezzilli1, M Miglioli. 1. Emergency Department, Sant'Orsola Hospital, Bologna, Italy. pezzilli@orsola-malpighi.med.unibo.it
Abstract
AIM: To compare the efficacy of two different schedules of gabexate mesilate (900 mg/day, or 1,500 mg/day) in the treatment of severe acute pancreatitis. SETTING: Forty-two Italian medical and surgical centres took part in the study. STUDY DESIGN: A multicentre, prospective, open label, comparative, parallel-group, randomized study. METHODS: The patients enrolled in the study had acute pancreatitis as demonstrated by typical abdominal pain and baseline serum amylase concentrations more than twice the upper normal limit, findings compatible with acute pancreatitis at imaging techniques, and a Glasgow criteria score of > or =3. Patients were randomly assigned to one of the two schedules of treatment with gabexate mesilate being administered intravenously for at least 7 days. The minimum clinically relevant difference (delta), between groups, in incidence of complications due to acute pancreatitis, during the first month of the study treatment, was predefined as equal to 10%. RESULTS:A total of 199 patients were assigned to gabexate mesilate 900 treatment and 189 to gabexate mesilate 1,500. Complications developed in 88 patients within one month of beginning treatment 44/199: patients (22.1%) in the gabexate mesilate 900 group and 44/189 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 mesilate 1,500 mg per day in reducing the complications due to acute pancreatitis.
RCT Entities:
AIM: To compare the efficacy of two different schedules of gabexate mesilate (900 mg/day, or 1,500 mg/day) in the treatment of severe acute pancreatitis. SETTING: Forty-two Italian medical and surgical centres took part in the study. STUDY DESIGN: A multicentre, prospective, open label, comparative, parallel-group, randomized study. METHODS: The patients enrolled in the study had acute pancreatitis as demonstrated by typical abdominal pain and baseline serum amylase concentrations more than twice the upper normal limit, findings compatible with acute pancreatitis at imaging techniques, and a Glasgow criteria score of > or =3. Patients were randomly assigned to one of the two schedules of treatment with gabexate mesilate being administered intravenously for at least 7 days. The minimum clinically relevant difference (delta), between groups, in incidence of complications due to acute pancreatitis, during the first month of the study treatment, was predefined as equal to 10%. RESULTS: A total of 199 patients were assigned to gabexate mesilate 900 treatment and 189 to gabexate mesilate 1,500. Complications developed in 88 patients within one month of beginning treatment 44/199: patients (22.1%) in the gabexate mesilate 900 group and 44/189 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 mesilate 1,500 mg per day in reducing the complications due to acute pancreatitis.
Authors: Elham Afghani; Stephen J Pandol; Tooru Shimosegawa; Robert Sutton; Bechien U Wu; Santhi Swaroop Vege; Fred Gorelick; Morihisa Hirota; John Windsor; Simon K Lo; Martin L Freeman; Markus M Lerch; Yoshihisa Tsuji; Gil Y Melmed; Wahid Wassef; Julia Mayerle Journal: Pancreas Date: 2015-11 Impact factor: 3.327