Since the effectiveness of gabexate mesilate in patients with acute pancreatitis is controversial, a metaanalysis of the published literature was conducted to address this problem. Five randomized trials were identified by our literature search. Three end points (mortality, complications, and complications requiring surgery) were evaluated. The results of our metaanalysis indicate that the treatment with gabexate mesilate does not affect mortality at 90 days (P = 0.27), but significantly reduces the incidence of complications requiring surgery (odds ratio = 0.61, 95% CI: 0.41-0.89; P < 0.05) and of complications in general (odds ratio = 0.69, 95% CI: 0.54-0.89; P < 0.05). Because the drug proves to be beneficial only to a low proportion of the treated patients, its clinical impact seems to be small. A pharmacoeconomic evaluation shows that its use in all patients with acute pancreatitis would imply a very high cost for preventing each complication. The administration of the drug to select patients who are at higher risk of complications could have a better cost-effectiveness ratio. However, specific studies on this point are still lacking.