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.
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Authors | K Higuchi, T Watanabe, T Tanigawa, M Shiba, K Tominaga, Y Fujiwara, N Oshitani, T Arakawa |
Journal | Inflammopharmacology
(Inflammopharmacology)
Vol. 15
Issue 1
Pg. 18-21
(Feb 2007)
ISSN: 0925-4692 [Print] Switzerland |
PMID | 17323190
(Publication Type: Comparative Study, Journal Article)
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Chemical References |
- Anti-Ulcer Agents
- cetraxate
- Tranexamic Acid
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Topics |
- Anti-Ulcer Agents
(therapeutic use)
- Gastric Mucosa
(drug effects)
- Guidelines as Topic
(standards)
- Humans
- Randomized Controlled Trials as Topic
- Research Design
(standards)
- Retrospective Studies
- Stomach Ulcer
(drug therapy)
- Tranexamic Acid
(analogs & derivatives, therapeutic use)
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