Therapeutic Efficacy of Gliptide<sup>&#9415; </sup>(Sulglycotide) on Gastritis - A Single Blind, Randomized, Active Drug Comparative, Multi-center, Phase IV Study-

Original

The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2005;5(2):233-239.
Published online December 3, 2005.

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

위염환자에서 글립타이드정^Ⓡ 200 mg (Sulglycotide)의 치료 효과 - 단일맹검, 무작위 배정, 비교약 대조, 다기관 4상 임상시험 -

김지현·윤영훈·조용석*·윤용범^†·류지곤^†·이동호^‡·김나영^‡·박영수^‡·이국래^§·김지원^§ 김병관^§·이용찬

연세대학교 의과대학 내과학교실, 국민건강보험공단 일산병원 소화기내과*, 서울대학교 의과대학 내과학교실^†, 분당서울대학교병원 내과^‡, 서울시립보라매병원 소화기내과^§

Abstract

Background/Aims: Sulglycotide is a glycopeptide isolated from pig duodenum constituents. Sulglycotide is know to induce increased excretion of bicarbonate and prostaglandins in gastric juice and recent studies have shown various anti H. pylori effect of sulglycotide in vitro and in vivo. The purpose of this study was to assess the therapeutic efficacy and safety of Gliptide^TM (sulglycotide) in comparison with another mucosal protectants, Stillen^TM for the treatment of gastritis. Methods: One hundread and fifty patients with acute or chronic gastritis with various dyspeptic symptoms were enrolled and underwent a single-blind, randomized, active drug comparative trial vs Stillen. Each group received either Gliptide^TM (oral, 200 mg t.i.d. for 4 weeks, n=76) or Stillen^TM (oral, 180 mg t.i.d. for 4 weeks, n= 74). Drug effectiveness was evaluated in terms of apparent clinical symptom improvements and follow-up endoscopic scorings for evaluations. Results: Gliptide^TM or Stillen^TM treatment have resulted in endoscopic improvement rates of gastritis by 38.2% vs. 32.4% (ITT) and 47.5% vs. 39.3% (PP) respectively. Both treatments have resulted in the prompt improvements of the dyspeptic symptoms effectively (gliptide group, 63.2% and stillen group, 56.8% respectively, ITT). Endoscopic cure rates in gliptide and stillen groups were comparable to each other (25.0% vs. 20.3% by ITT, 32.2% vs. 26.8% by PP respectively). Endoscopic cure rates and improvement rates as well as symptom improvements indices were not significantly different between Gliptide^TM and Stillen^TM treated groups. No significant adverse events were encountered during the study period. Conclusions: This study clearly shows that the Gliptide^TM is an effective and safe drug for the treatment of gastritis accompanied by dyspeptic symptoms in Korea. (The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2005;5:233-240)

Key Words: Gliptide^TM, Sulglycotide, Gastirits, Dyspepsia