Therapeutic Efficacy of Gliptide (Sulglycotide 200 mg): A Double Blinded, Randomized, Active Drug Comparative, Multicenter Study

BACKGROUND/AIMS: Sulglycotide is a non-systemic drug, used in the treatment of peptic ulcer and gastritis. The aim of this study was to assess the therapeutic effect and safety of Gliptide (sulglycotide 200 mg) in comparison with Mucosta (rebamipide 100 mg) for treatment of gastritis. MATERIALS AND METHODS: Two hundred and three symptomatic patients with erosive gastritis at endoscopy were randomized to receive sulglycotide or rebamipide for four weeks. Therapeutic effects of the drugs for gastritis were evaluated by follow up endoscopic scoring systems and clinical symptoms. We also sought possible adverse effects of the two drugs. RESULTS: Gliptide (sulglycotide) and Mucosta (rebamipide) treatment in symptomatic gastritis resulted in endoscopic improvement rates of gastritis by 52.0%, 60.6% in intention-to-treat (ITT) analysis, 53.4%, 61.1% in per protocol (PP) analysis, which means therapeutic effects was not different between the two groups. The symptom improvement rates in the sulglycotide and rebamipide treated group were 57.3%, 57.5% in ITT analysis, 54.7%, 58.8% in PP analysis, which mean statistically no significant difference between the two groups. Endoscopic findings such as cure rates of erosion, edema, improvement rates of redness, hemorrhage were not significantly different between the two groups. No statistical significant differences were observed for adverse events between the two groups. The results of 95% CIs for the difference in endoscopic improvement rate and symptom improvement rate met the criteria for the non-inferiority of sulglycotide to rebamipide. CONCLUSIONS: These results demonstrate that Gliptide (sulglycotide) was not inferior to Mucosta (rebamipide) for endoscopic and symptomatic improvements for symptomatic erosive gastritis.

Therapeutic Efficacy of Gliptide(R) (Sulglycotide) on Gastritis - A Double Blind, Randomized, Active Drug Comparative, Multi-Center, Phase IV Study

BACKGROUND/AIMS: Sulglycotide is a sulphoglycopeptide isolated from porcine duodenal mucosa. It has antiulcer and cytoprotective activity with anti Helicobacter pylori (H. pylori) effect. This study was performed to assess the therapeutic efficacy and safety of gliptide(R) (sulglycotide) in comparison with another mucosal protective agent, selbex(R) (teprenone) for the treatment of gastritis. MATERIALS AND METHODS: One hundred and twenty one patients with symptomatic erosive gastritis were randomized to receive sulglycotide (gliptide(R)) or teprenone (selbex(R)) for 4 weeks. Improvement and cure rates on endoscopic findings, improvement rates of symptoms, and eradication rates of H. pylori were compared. RESULTS: Of the 121 intention-to-treat (ITT) population, 82 patients comprised the per protocol (PP) analysis. Endoscopic cure rates and improvement rates in the sulglycotide and teprenone group were 36.7% vs. 29.5% and 41.7% vs. 37.7% in ITT and 46.3% vs. 34.2% and 53.7% vs. 43.9% in PP population, respectively. Symptom improvement rates in the sulglycotide and teprenone group were 71.7% vs. 65.6% in ITT and 85.4% vs. 75.6% in PP. Eradication rates of H. pylori were not significantly different between the groups. Results of 95% CIs for the difference in endoscopic cure rate and improvement rate, symptom improvement rate, and eradication rate of H. pylori between the two groups met the criteria for the non-inferiority of sulglycotide to teprenone. No significant adverse events were encountered during the study period. CONCLUSIONS: Gliptide(R) (sulglycotide) is not inferior to selbex(R) (teprenone) in therapeutic efficacy and is a safe and useful therapeutic agent for the treatment of gastritis.