Irsogladine maleate reduces the incidence of fluorouracil-based
chemotherapy-induced oral mucositis.
Author(s): Nomura M(1), Kamata M, Kojima H, Hayashi K, Sawada S.
Affiliation(s): Author information:
(1)Department of Radiology, Kansai Medical University, Hirakata, Japan.
excell@hkg.odn.ne.jp
Publication date & source: 2013, Ann Oncol. , 24(4):1062-6
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.
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