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.

journal_name

Inflammopharmacology

journal_title

Inflammopharmacology

authors

Higuchi K,Watanabe T,Tanigawa T,Shiba M,Tominaga K,Fujiwara Y,Oshitani N,Arakawa T

doi

10.1007/s10787-006-0300-y

subject

Has Abstract

pub_date

2007-02-01 00:00:00

pages

18-21

issue

1

eissn

0925-4692

issn

1568-5608

journal_volume

15

pub_type

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