Are gastroprotective drugs useful for gastric ulcer healing: re-evaluation using current ICH E9 guidelines.

Most of the gastroprotective drugs which had been marketed in Japan were considered to have insufficient rationale for use as ulcer treatments. Such drugs may have a crucial role in maintaining mucosal integrity by the mechanisms other than inhibition of acid secretion. We re-evaluated the effect of gastroprotective drugs on gastric ulcer healing using current ICH E9 guidelines. We collected reports of pivotal trials on healing rate of gastric ulcer with 9 kinds of gastroprotective drugs submitted in New Drug Applications. In the comparative trial of cetraxate vs. placebo, the healing rate of gastric ulcer at 8-week endoscopy in the cetraxate was significantly higher than that in the placebo groups (88.6% and 62.2%, p = 0.0062). Non-inferiority to cetraxate was confirmed for 8 kinds of gastroprotective drugs. In conclusion, the superiority of cetraxate over placebo and non-inferiority to cetraxate for 7 drugs was established in the respect of effect on ulcer healing.