Background: A multicenter controlled study was performed to evaluate the effect of high doses of the low molecular weight protease inhibitor gabexate mesilate on mortality and complications associated with moderate and severe acute pancreatitis.
Methods: Two hundred twenty-three patients from 29 hospitals were entered in the randomized, double-blind trial. Admission to the study was based on strict criteria excluding mild acute pancreatitis. The patients received placebo or 4 g gabexate mesilate per day intravenously for 7 days. All patients were followed up for 90 days after randomization. The analysis was based on 14 complications, including death.
Results: There was no statistical difference in either mortality or complications associated with acute pancreatitis between the placebo and gabexate mesilate groups.
Conclusions: The results show that gabexate mesilate was not effective in preventing complications and mortality in acute pancreatitis.