title: Are gastroprotective drugs useful for gastric ulcer healing: re-evaluation using current ICH E9 guidelines.
abstract: 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.
authors.affiliation: Department of Gastroenterology, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan. khiguchi@med.osaka-cu.ac.jp
authors.forename: K
authors.initials: K
authors.lastname: Higuchi
authors.forename: T
authors.initials: T
authors.lastname: Watanabe
authors.forename: T
authors.initials: T
authors.lastname: Tanigawa
authors.forename: M
authors.initials: M
authors.lastname: Shiba
authors.forename: K
authors.initials: K
authors.lastname: Tominaga
authors.forename: Y
authors.initials: Y
authors.lastname: Fujiwara
authors.forename: N
authors.initials: N
authors.lastname: Oshitani
authors.forename: T
authors.initials: T
authors.lastname: Arakawa
mesh_terms: D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D005753:Gastric Mucosa / Q000187:drug effects; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000592:standards; D012189:Retrospective Studies; D013276:Stomach Ulcer / Q000188:drug therapy*; D014148:Tranexamic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D000897:Anti-Ulcer Agents; C000665:cetraxate; D014148:Tranexamic Acid