1.Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study
Jie-Hyun KIM ; Hwoon-Yong JUNG ; In Kyung YOO ; Seon-Young PARK ; Jae Gyu KIM ; Jae Kyu SUNG ; Jin Seok JANG ; Gab Jin CHEON ; Kyoung Oh KIM ; Tae Oh KIM ; Soo Teik LEE ; Kwang Bum CHO ; Hoon Jai CHUN ; Jong-Jae PARK ; Moo In PARK ; Jae-Young JANG ; Seong Woo JEON ; Jin Woong CHO ; Dae Hwan KANG ; Gwang Ha KIM ; Jae J. KIM ; Sang Gyun KIM ; Nayoung KIM ; Yong Chan LEE ; Su Jin HONG ; Hyun-Soo KIM ; Sora LEE ; Sang Woo LEE
Gut and Liver 2024;18(1):70-76
Background/Aims:
H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA.However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis.
Methods:
A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared.
Results:
According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different.
Conclusions
DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
2.Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis
Gwang Ha KIM ; Myung-Gyu CHOI ; Jin Il KIM ; Soo Teik LEE ; Hoon Jai CHUN ; Kook Lae LEE ; Suk Chei CHOI ; Jae-Young JANG ; Yong Chan LEE ; Jae Gyu KIM ; Ki Bae KIM ; Ki-Nam SHIM ; Chong Il SOHN ; Sung Kook KIM ; Sang Gyun KIM ; Jin Seok JANG ; Nayoung KIM ; Hwoon-Yong JUNG ; Hyojin PARK ; Kyu Chan HUH ; Kwang Jae LEE ; Su Jin HONG ; Song BAEK ; Jin Joo HAN ; Oh Young LEE
Gut and Liver 2023;17(6):884-893
Background/Aims:
Fexuprazan is a novel potassium-competitive acid blocker that could be of benefit to patients with gastric mucosal injury. The aim of this study was to assess the 2-week efficacy and safety of fexuprazan in patients with acute or chronic gastritis.
Methods:
In this study, 327 patients with acute or chronic gastritis who had one or more gastric erosions on endoscopy and subjective symptoms were randomized into three groups receiving fexuprazan 20 mg once a day (q.d.), fexuprazan 10 mg twice a day (b.i.d.), or placebo for 2 weeks. The posttreatment assessments were the primary endpoint (erosion improvement rate), secondary endpoints (cure rates of erosion and edema and improvement rates of redness, hemorrhage, and subjective symptoms), and drug-related adverse events.
Results:
Among the patients, 57.8% (59/102), 65.7% (67/102), and 40.6% (39/96) showed erosion improvement 2 weeks after receiving fexuprazan 20 mg q.d., fexuprazan 10 mg b.i.d., and placebo, respectively. Both fexuprazan 20 mg q.d. and 10 mg b.i.d. showed superior efficacy to the placebo (p=0.017 and p<0.001, respectively). Likewise, both fexuprazan 20 mg q.d. and 10 mg b.i.d. also showed higher erosion healing rates than the placebo (p=0.033 and p=0.010, respectively). No difference was noted in the edema healing rate and the improvement rates for redness, hemorrhage, and subjective symptoms between the fexuprazan and placebo groups.No significant difference was noted in the incidence of adverse drug reactions.
Conclusions
Fexuprazan 20 mg q.d. and 10 mg b.i.d. for 2 weeks showed therapeutic efficacy superior to that of placebo in patients with acute or chronic gastritis (ClinicalTrials.gov identifier NCT04341454).
3.Discovery of Cellular RhoA Functions by the Integrated Application of Gene Set Enrichment Analysis
Biomolecules & Therapeutics 2022;30(1):98-116
The small GTPase RhoA has been studied extensively for its role in actin dynamics. In this study, multiple bioinformatics tools were applied cooperatively to the microarray dataset GSE64714 to explore previously unidentified functions of RhoA. Comparative gene expression analysis revealed 545 differentially expressed genes in RhoA-null cells versus controls. Gene set enrichment analysis (GSEA) was conducted with three gene set collections: (1) the hallmark, (2) the Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway, and (3) the Gene Ontology Biological Process. GSEA results showed that RhoA is related strongly to diverse pathways: cell cycle/growth, DNA repair, metabolism, keratinization, response to fungus, and vesicular transport. These functions were verified by heatmap analysis, KEGG pathway diagramming, and direct acyclic graphing. The use of multiple gene set collections restricted the leakage of information extracted. However, gene sets from individual collections are heterogenous in gene element composition, number, and the contextual meaning embraced in names. Indeed, there was a limit to deriving functions with high accuracy and reliability simply from gene set names. The comparison of multiple gene set collections showed that although the gene sets had similar names, the gene elements were extremely heterogeneous. Thus, the type of collection chosen and the analytical context influence the interpretation of GSEA results. Nonetheless, the analyses of multiple collections made it possible to derive robust and consistent function identifications. This study confirmed several well-described roles of RhoA and revealed less explored functions, suggesting future research directions.
4.Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial
Yoon Jin CHOI ; Yong Chan LEE ; Jung Mogg KIM ; Jin Il KIM ; Jeong Seop MOON ; Yun Jeong LIM ; Gwang Ho BAIK ; Byoung Kwan SON ; Hang Lak LEE ; Kyoung Oh KIM ; Nayoung KIM ; Kwang Hyun KO ; Hye-Kyung JUNG ; Ki-Nam SHIM ; Hoon Jai CHUN ; Byung-Wook KIM ; Hyuk LEE ; Jie-Hyun KIM ; Hyunsoo CHUNG ; Sang Gyun KIM ; Jae Young JANG
Gut and Liver 2022;16(4):535-546
Background/Aims:
We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication.
Methods:
A randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)-based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases.
Results:
In total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences.
Conclusions
TPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea
5.Clinical and Technical Guideline for Endoscopic Ultrasound-Guided Tissue Acquisition of Pancreatic Solid Tumor: Korean Society of Gastrointestinal Endoscopy
Moon Jae CHUNG ; Se Woo PARK ; Seong-Hun KIM ; Chang Min CHO ; Jun-Ho CHOI ; Eun Kwang CHOI ; Tae Hoon LEE ; Eunae CHO ; Jun Kyu LEE ; Tae Jun SONG ; Jae Min LEE ; Jun Hyuk SON ; Jin Suk PARK ; Chi Hyuk OH ; Dong-Ah PARK ; Jeong-Sik BYEON ; Soo Teik LEE ; Ho Gak KIM ; Hoon Jai CHUN ; Ho Soon CHOI ; Chan Guk PARK ; Joo Young CHO
Korean Journal of Pancreas and Biliary Tract 2021;26(4):263-264
6.Clinical and Technical Guideline for Endoscopic Ultrasound (EUS)-Guided Tissue Acquisition of Pancreatic Solid Tumor: Korean Society of Gastrointestinal Endoscopy (KSGE)
Moon Jae CHUNG ; Se Woo PARK ; Seong-Hun KIM ; Chang Min CHO ; Jun-Ho CHOI ; Eun Kwang CHOI ; Tae Hoon LEE ; Eunae CHO ; Jun Kyu LEE ; Tae Jun SONG ; Jae Min LEE ; Jun Hyuk SON ; Jin Suk PARK ; Chi Hyuk OH ; Dong-Ah PARK ; Jeong-Sik BYEON ; Soo Teik LEE ; Ho Gak KIM ; Hoon Jai CHUN ; Ho Soon CHOI ; Chan Guk PARK ; Joo Young CHO
Clinical Endoscopy 2021;54(2):161-181
Endoscopic ultrasound (EUS)-guided tissue acquisition of pancreatic solid tumor requires a strict recommendation for its proper use in clinical practice because of its technical difficulty and invasiveness. The Korean Society of Gastrointestinal Endoscopy (KSGE) appointed a Task Force to draft clinical practice guidelines for EUS-guided tissue acquisition of pancreatic solid tumor. The strength of recommendation and the level of evidence for each statement were graded according to the Minds Handbook for Clinical Practice Guideline Development 2014. The committee, comprising a development panel of 16 endosonographers and an expert on guideline development methodology, developed 12 evidence-based recommendations in 8 categories intended to help physicians make evidence-based clinical judgments with regard to the diagnosis of pancreatic solid tumor. This clinical practice guideline discusses EUS-guided sampling in pancreatic solid tumor and makes recommendations on circumstances that warrant its use, technical issues related to maximizing the diagnostic yield (e.g., needle type, needle diameter, adequate number of needle passes, sample obtaining techniques, and methods of specimen processing), adverse events of EUS-guided tissue acquisition, and learning-related issues. This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This guideline may not be applicable for all clinical situations and should be interpreted in light of specific situations and the availability of resources. It will be revised as necessary to cover progress and changes in technology and evidence from clinical practice.
7.Clinical and Technical Guideline for Endoscopic Ultrasound (EUS)-Guided Tissue Acquisition of Pancreatic Solid Tumor: Korean Society of Gastrointestinal Endoscopy (KSGE)
Moon Jae CHUNG ; Se Woo PARK ; Seong-Hun KIM ; Chang Min CHO ; Jun-Ho CHOI ; Eun Kwang CHOI ; Tae Hoon LEE ; Eunae CHO ; Jun Kyu LEE ; Tae Jun SONG ; Jae Min LEE ; Jun Hyuk SON ; Jin Suk PARK ; Chi Hyuk OH ; Dong-Ah PARK ; Jeong-Sik BYEON ; Soo Teik LEE ; Ho Gak KIM ; Hoon Jai CHUN ; Ho Soon CHOI ; Chan Guk PARK ; Joo Young CHO
Gut and Liver 2021;15(3):354-374
Endoscopic ultrasound (EUS)-guided tissue acquisition of pancreatic solid tumor requires a strict recommendation for its proper use in clinical practice because of its technical difficulty and invasiveness. The Korean Society of Gastrointestinal Endoscopy (KSGE) appointed a task force to draft clinical practice guidelines for EUS-guided tissue acquisition of pancreatic solid tumor. The strength of recommendation and the level of evidence for each statement were graded according to the Minds Handbook for Clinical Practice Guideline Development 2014. The committee, comprising a development panel of 16 endosonographers and an expert on guideline development methodology, developed 12 evidence-based recommendations in eight categories intended to help physicians make evidence-based clinical judgments with regard to the diagnosis of pancreatic solid tumor. This clinical practice guideline discusses EUS-guided sampling in pancreatic solid tumor and makes recommendations on circumstances that warrant its use, technical issues related to maximizing the diagnostic yield (e.g., needle type, needle diameter, adequate number of needle passes, sample obtaining techniques, and methods of specimen processing), adverse events of EUS-guided tissue acquisition, and learning-related issues. This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This guideline may not be applicable for all clinical situations and should be interpreted in light of specific situations and the availability of resources. It will be revised as necessary to cover progress and changes in technology and evidence from clinical practice.
8.Clinical and Technical Guideline for Endoscopic Ultrasound-Guided Tissue Acquisition of Pancreatic Solid Tumor: Korean Society of Gastrointestinal Endoscopy
Moon Jae CHUNG ; Se Woo PARK ; Seong-Hun KIM ; Chang Min CHO ; Jun-Ho CHOI ; Eun Kwang CHOI ; Tae Hoon LEE ; Eunae CHO ; Jun Kyu LEE ; Tae Jun SONG ; Jae Min LEE ; Jun Hyuk SON ; Jin Suk PARK ; Chi Hyuk OH ; Dong-Ah PARK ; Jeong-Sik BYEON ; Soo Teik LEE ; Ho Gak KIM ; Hoon Jai CHUN ; Ho Soon CHOI ; Chan Guk PARK ; Joo Young CHO
Korean Journal of Pancreas and Biliary Tract 2021;26(3):125-147
Endoscopic ultrasound (EUS)-guided tissue acquisition of pancreatic solid tumor requires a strict recommendation for its proper use in clinical practice because of its technical difficulty and invasiveness. The Korean Society of Gastrointestinal Endoscopy appointed a Task Force to draft clinical practice guidelines for EUS-guided tissue acquisition of pancreatic solid tumor. The strength of recommendation and the level of evidence for each statement were graded according to the Minds Handbook for Clinical Practice Guideline Development 2014. The committee, comprising a development panel of 16 endosonographers and an expert on guideline development methodology, developed 12 evidence-based recommendations in eight categories intended to help physicians make evidence-based clinical judgments with regard to the diagnosis of pancreatic solid tumor. This clinical practice guideline discusses EUS-guided sampling in pancreatic solid tumor and makes recommendations on circumstances that warrant its use, technical issues related to maximizing the diagnostic yield (e.g., needle type, needle diameter, adequate number of needle passes, sample obtaining techniques, and methods of specimen processing), adverse events of EUS-guided tissue acquisition, and learning-related issues. This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This guideline may not be applicable for all clinical situations and should be interpreted in light of specific situations and the availability of resources. It will be revised as necessary to cover progress and changes in technology and evidence from clinical practice.
9.Clinical and Technical Guideline for Endoscopic Ultrasound-guided Tissue Acquisition of Pancreatic Solid Tumor: Korean Society of Gastrointestinal Endoscopy
Moon Jae CHUNG ; Se Woo PARK ; Seong-Hun KIM ; Chang Min CHO ; Jun-Ho CHOI ; Eun Kwang CHOI ; Tae Hoon LEE ; Eunae CHO ; Jun Kyu LEE ; Tae Jun SONG ; Jae Min LEE ; Jun Hyuk SON ; Jin Suk PARK ; Chi Hyuk OH ; Dong-Ah PARK ; Jeong-Sik BYEON ; Soo Teik LEE ; Ho Gak KIM ; Hoon Jai CHUN ; Ho Soon CHOI ; Chan Guk PARK ; Joo Young CHO
The Korean Journal of Gastroenterology 2021;78(2):73-93
Endoscopic ultrasound (EUS)-guided tissue acquisition of pancreatic solid tumor requires a strict recommendation for its proper use in clinical practice because of its technical difficulty and invasiveness. The Korean Society of Gastrointestinal Endoscopy appointed a Task Force to draft clinical practice guidelines for EUS-guided tissue acquisition of pancreatic solid tumor. The strength of recommendation and the level of evidence for each statement were graded according to the Minds Handbook for Clinical Practice Guideline Development 2014. The committee, comprising a development panel of 16 endosonographers and an expert on guideline development methodology, developed 12 evidence-based recommendations in eight categories intended to help physicians make evidence-based clinical judgments with regard to the diagnosis of pancreatic solid tumor. This clinical practice guideline discusses EUS-guided sampling in pancreatic solid tumor and makes recommendations on circumstances that warrant its use, technical issues related to maximizing the diagnostic yield (e.g., needle type, needle diameter, adequate number of needle passes, sample obtaining techniques, and methods of specimen processing), adverse events of EUS-guided tissue acquisition, and learning-related issues.This guideline was reviewed by external experts and suggests best practices recommended based on the evidence available at the time of preparation. This guideline may not be applicable for all clinical situations and should be interpreted in light of specific situations and the availability of resources. It will be revised as necessary to cover progress and changes in technology and evidence from clinical practice
10.Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, Active Control, Noninferiority, Multicenter, Phase 3 Study
Gwang Ha KIM ; Hang Lak LEE ; Moon Kyung JOO ; Hong Jun PARK ; Sung Woo JUNG ; Ok-Jae LEE ; Hyungkil KIM ; Hoon Jai CHUN ; Soo Teik LEE ; Ji Won KIM ; Han Ho JEON ; Il-Kwun CHUNG ; Hyun-Soo KIM ; Dong Ho LEE ; Kyoung-Oh KIM ; Yun Jeong LIM ; Seun-Ja PARK ; Soo-Jeong CHO ; Byung-Wook KIM ; Kwang Hyun KO ; Seong Woo JEON ; Jae Gyu KIM ; In-Kyung SUNG ; Tae Nyeun KIM ; Jae Kyu SUNG ; Jong-Jae PARK
Gut and Liver 2021;15(6):841-850
Background/Aims:
The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis.
Methods:
This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated.
Results:
According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates.
Conclusions
The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

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