Irsogladine maleate reduces the incidence of fluorouracil-based chemotherapy-induced oral mucositis.

BACKGROUND Oral mucositis is one of the most common side-effects of 5-fluorouracil (5-FU)-based chemotherapy. The objective of this study was to evaluate the effects of irsogladine maleate (IM) on fluorouracil-induced oral mucositis through a double-blind, placebo controlled trial. PATIENTS AND METHODS Patients (N = 66) were randomly assigned to receive either placebo or IM (4 mg/day for 14 consecutive days). The incidence and maximum severity of fluorouracil-induced oral mucositis and safety of the irsogladine dosing regimen were evaluated. RESULTS A cohort of 33 patients received placebo and 33 patients received IM. The incidence of oral mucositis was significantly lower for IM than for placebo (27% versus 73%; P < 0.001 by chi-square test). Specific adverse events considered related to IM were not found. CONCLUSION IM significantly reduced the incidence and maximum severity of oral mucositis in patients treated with 5-FU-chemotherapy.