Irsogladine Maleate Accelerates Ulcer Healing After Treatment for H Pylori
Irsogladine Maleate Accelerates Ulcer Healing After Treatment for H Pylori
BackgroundHelicobacter pylori eradication therapy alone is not sufficient to heal all gastric ulcers.
Aim To verify the efficacy of treatment with irsogladine maleate between the termination and assessment of treatment for eradicating H. pylori in a double-blind study.
MethodsThree hundred and twenty-two patients with a single H. pylori-positive gastric ulcer were given eradication treatment, then assigned randomly to a treatment group [given 4 mg/day irsogladine maleate (n = 150)] or a control group [given a placebo (n = 161)]. The gastric ulcer healing rates were compared after 7 weeks of treatment.
Results The healing rate was significantly higher in the irsogladine maleate group (83.0%) than in the placebo group (72.2%; χ test, P = 0.0276). In the subgroup analysis of cases of eradication failure, the gastric ulcer healing rate was significantly higher in the irsogladine maleate group (57.9%) than in the placebo group (26.1%; χ test, P = 0.0366).
Conclusions Irsogladine maleate was effective for treating gastric ulcer after H. pylori eradication. The high healing rates observed in patients with or without successful eradication demonstrate the usefulness of irsogladine maleate treatment regardless of the outcome of eradication.
For gastric ulcers associated with Helicobacter pylori (H. pylori) infection, a triple therapy to eradicate the bacterium is recommended that consists of a proton pump inhibitor (PPI), amoxicillin, and clarithromycin. Remarkable reductions in the relapse rate of gastric ulcers have been reported with the use of this combination therapy. Some authors believe that eradication of H. pylori should be performed after the gastric ulcer has been treated, whereas others believe that eradication treatment should be initiated when the gastric ulcer is first identified and H. pylori has been diagnosed. However, the eradication treatment is often started at the time of diagnosis of a gastric ulcer because the treatment for H. pylori eradication seems to have no adverse effect on ulcer healing. Although it has been reported in studies from Europe and the United States that eradication treatment alone is sufficient to cure peptic ulcers, these results have been obtained predominantly for duodenal ulcers and therefore cannot be extrapolated to the treatment of gastric ulcers, which occur frequently in the Japanese population. Lai et al. have reported that the rate of healing of gastric ulcers is significantly lower than the rate of healing of duodenal ulcers after the eradication of H. pylori. They demonstrated the need for the continued treatment of gastric ulcers after eradication therapy. Higuchi et al. reported that the therapeutic effects of H. pylori eradication alone were insufficient to cure gastric ulcers in Japanese patients and that further treatment after eradication therapy is necessary for gastric ulcers in Japanese patients, unlike Caucasian patients. Moreover, the rate of eradication of H. pylori has decreased recently due to the development of increasing resistance to clarithromycin, which suggests that another drug therapy should be administered immediately after the eradication regimen has been performed until eradication is assessed.
During the period after the eradication treatment until the time of assessment, which is performed at least 4 weeks after the completion of eradication therapy, the results of the treatment remain unknown. Murakami et al. reported that 72.0% of gastric ulcer relapses are observed during this period. This suggests the need for further anti-ulcer treatment before the assessment of eradication because the risk of relapse is high, particularly in patients in whom eradication of H. pylori has failed. However, because the administration of PPIs and some histamine H2 receptor antagonists (H2RAs) is known to affect the assessment of eradication, it is desirable that these drugs are not given for at least 4 weeks before the eradication is assessed. Therefore, an anti-ulcer drug that does not interfere with the assessment of H. pylori eradication is required for use after eradication treatment.
Irsogladine maleate is an enhancer of gastric mucosal protective factors that is often prescribed in Japan, Korea and China. It increases the production of intracellular cyclic adenosine monophosphate (cAMP) by inhibiting phosphodiesterase activity and thus activates intracellular communication, prevents a reduction in gastric mucosal blood flow, increases anti-inflammatory activity and prevents the reduction of mucosal hydrophobicity. Its efficacy has been demonstrated in various models of gastric mucosal injury.
In a pilot study of irsogladine maleate given after H. pylori eradication treatment, the rate of healing of gastric ulcers was 79.2%. The present study was designed to verify the usefulness of irsogladine maleate when given during the period from immediately after the completion of H. pylori eradication treatment until the patient is assessed for eradication of the bacterium.
Abstract and Introduction
Abstract
BackgroundHelicobacter pylori eradication therapy alone is not sufficient to heal all gastric ulcers.
Aim To verify the efficacy of treatment with irsogladine maleate between the termination and assessment of treatment for eradicating H. pylori in a double-blind study.
MethodsThree hundred and twenty-two patients with a single H. pylori-positive gastric ulcer were given eradication treatment, then assigned randomly to a treatment group [given 4 mg/day irsogladine maleate (n = 150)] or a control group [given a placebo (n = 161)]. The gastric ulcer healing rates were compared after 7 weeks of treatment.
Results The healing rate was significantly higher in the irsogladine maleate group (83.0%) than in the placebo group (72.2%; χ test, P = 0.0276). In the subgroup analysis of cases of eradication failure, the gastric ulcer healing rate was significantly higher in the irsogladine maleate group (57.9%) than in the placebo group (26.1%; χ test, P = 0.0366).
Conclusions Irsogladine maleate was effective for treating gastric ulcer after H. pylori eradication. The high healing rates observed in patients with or without successful eradication demonstrate the usefulness of irsogladine maleate treatment regardless of the outcome of eradication.
Introduction
For gastric ulcers associated with Helicobacter pylori (H. pylori) infection, a triple therapy to eradicate the bacterium is recommended that consists of a proton pump inhibitor (PPI), amoxicillin, and clarithromycin. Remarkable reductions in the relapse rate of gastric ulcers have been reported with the use of this combination therapy. Some authors believe that eradication of H. pylori should be performed after the gastric ulcer has been treated, whereas others believe that eradication treatment should be initiated when the gastric ulcer is first identified and H. pylori has been diagnosed. However, the eradication treatment is often started at the time of diagnosis of a gastric ulcer because the treatment for H. pylori eradication seems to have no adverse effect on ulcer healing. Although it has been reported in studies from Europe and the United States that eradication treatment alone is sufficient to cure peptic ulcers, these results have been obtained predominantly for duodenal ulcers and therefore cannot be extrapolated to the treatment of gastric ulcers, which occur frequently in the Japanese population. Lai et al. have reported that the rate of healing of gastric ulcers is significantly lower than the rate of healing of duodenal ulcers after the eradication of H. pylori. They demonstrated the need for the continued treatment of gastric ulcers after eradication therapy. Higuchi et al. reported that the therapeutic effects of H. pylori eradication alone were insufficient to cure gastric ulcers in Japanese patients and that further treatment after eradication therapy is necessary for gastric ulcers in Japanese patients, unlike Caucasian patients. Moreover, the rate of eradication of H. pylori has decreased recently due to the development of increasing resistance to clarithromycin, which suggests that another drug therapy should be administered immediately after the eradication regimen has been performed until eradication is assessed.
During the period after the eradication treatment until the time of assessment, which is performed at least 4 weeks after the completion of eradication therapy, the results of the treatment remain unknown. Murakami et al. reported that 72.0% of gastric ulcer relapses are observed during this period. This suggests the need for further anti-ulcer treatment before the assessment of eradication because the risk of relapse is high, particularly in patients in whom eradication of H. pylori has failed. However, because the administration of PPIs and some histamine H2 receptor antagonists (H2RAs) is known to affect the assessment of eradication, it is desirable that these drugs are not given for at least 4 weeks before the eradication is assessed. Therefore, an anti-ulcer drug that does not interfere with the assessment of H. pylori eradication is required for use after eradication treatment.
Irsogladine maleate is an enhancer of gastric mucosal protective factors that is often prescribed in Japan, Korea and China. It increases the production of intracellular cyclic adenosine monophosphate (cAMP) by inhibiting phosphodiesterase activity and thus activates intracellular communication, prevents a reduction in gastric mucosal blood flow, increases anti-inflammatory activity and prevents the reduction of mucosal hydrophobicity. Its efficacy has been demonstrated in various models of gastric mucosal injury.
In a pilot study of irsogladine maleate given after H. pylori eradication treatment, the rate of healing of gastric ulcers was 79.2%. The present study was designed to verify the usefulness of irsogladine maleate when given during the period from immediately after the completion of H. pylori eradication treatment until the patient is assessed for eradication of the bacterium.