1.The Effect of Tegoprazan on the Treatment of Endoscopic Resection-Induced Artificial Ulcers: A Multicenter, Randomized, Active-Controlled Study
Byung-Wook KIM ; Jong Jae PARK ; Hee Seok MOON ; Wan Sik LEE ; Ki-Nam SHIM ; Gwang Ho BAIK ; Yun Jeong LIM ; Hang Lak LEE ; Young Hoon YOUN ; Jun Chul PARK ; In-Kyung SUNG ; Hyunsoo CHUNG ; Jeong Seop MOON ; Gwang Ha KIM ; Su Jin HONG ; Hyuk Soon CHOI
Gut and Liver 2024;18(2):257-264
Background/Aims:
Tegoprazan is a novel potassium-competitive acid blocker that has beneficial effects on acid-related disorders such as gastroesophageal reflux and peptic ulcer diseases.This study aimed to validate the effect of tegoprazan on endoscopic submucosal dissection (ESD)-induced artificial ulcers.
Methods:
Patients from 16 centers in Korea who underwent ESD for gastric neoplasia were enrolled. After ESD, pantoprazole was administered intravenously for 48 hours. The patients were randomly allocated to either the tegoprazan or esomeprazole group. Tegoprazan 50 mg or esomeprazole 40 mg were administered for 4 weeks, after which gastroscopic evaluation was performed. If the artificial ulcer had not healed, the same dose of tegoprazan or esomeprazole was administered for an additional 4 weeks, and a gastroscopic evaluation was performed.
Results:
One hundred sixty patients were enrolled in this study. The healing rates of artificial ulcers at 4 weeks were 30.3% (23/76) and 22.1% (15/68) in the tegoprazan and esomeprazole groups, respectively (p=0.006). At 8 weeks after ESD, the cumulative ulcer healing rates were 73.7% (56/76) and 77.9% (53/68) in the tegoprazan and esomeprazole groups, respectively (p=0.210). Delayed bleeding occurred in two patients in the tegoprazan group (2.6%) and in one patient in the esomeprazole group (1.5%). Other adverse events were negligible in both groups.
Conclusions
Tegoprazan showed similar effects on post-ESD artificial ulcer healing in comparison with esomeprazole.
2.Hepatitis C Virus Seroprevalence in Persons Who Inject Drugs in Korea, 2012–2022: A Multicenter, Retrospective Study
Jihye KIM ; Gwang Hyeon CHOI ; Og-Jin JANG ; Younghoon CHON ; Sung Nam CHO ; Dohoon KWON ; Sook-Hyang JEONG
Journal of Korean Medical Science 2023;38(48):e357-
Background:
Limited data are available on hepatitis C virus (HCV) infection in persons who inject drugs (PWID) in South Korea. The present study aimed to investigate the seroprevalence of HCV antibodies, risk factors for HCV seropositivity, and HCV treatment status in PWID between January 2012 and May 2022.
Methods:
We retrospectively reviewed the medical records of 418 drug users who underwent HCV antibody testing in three hospitals caring for 90% of known PWID in South Korea, of whom 373 were PWID.
Results:
The HCV seroprevalence was 39.7% (148/373) in PWID vs. 6.7% (3/45) in noninjection drug users (P < 0.001). Age ≥ 40 years, hospital type (58.2% in the prison hospital vs. 34.0% in the private hospital), and enrollment year (68.2% in 2012–2014 vs. 30.0% in 2021–2022) were independently associated with HCV seropositivity. Among the HCVseropositive PWID, 90.5% (134/148) were diagnosed with HCV infection; however, only 6.8% (10/148) received HCV treatment. The hepatitis B virus surface antigen and human immunodeficiency virus antibody positivity were 4.0% (14/352) and 1.9% (6/317) in tested PWID, respectively.
Conclusion
The HCV seroprevalence in PWID was 39.7% with a very low treatment rate, which prompts active measures to test and treat PWID for HCV infection in South Korea.
3.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).
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.Erratum: Changes in bioimpedance analysis components before and after hemodialysis Volume 37, Issue 4, December 2018, Pages 393–403
Hyunsuk KIM ; Gwang Ho CHOI ; Kwang Eon SHIM ; Jung Hoon LEE ; Nam Ju HEO ; Kwon Wook JOO ; Jong Woo YOON ; Yun Kyu OH
Kidney Research and Clinical Practice 2019;38(1):128-129
The authors would like to publish this corrigendum to correct the data in Table 2 of the above article.
6.The efficacy and safety of irsogladine maleate in nonsteroidal anti-inflammatory drug or aspirin-induced peptic ulcer and gastritis
Ki Nam SHIM ; Jin Il KIM ; Nayoung KIM ; Sang Gyun KIM ; Yun Ju JO ; Su Jin HONG ; Jeong Eun SHIN ; Gwang Ha KIM ; Kyung Sik PARK ; Suck Chei CHOI ; Joong Goo KWON ; Jie Hyun KIM ; Hyun Jin KIM ; Ji Won KIM
The Korean Journal of Internal Medicine 2019;34(5):1008-1021
BACKGROUND/AIMS:
Irsogladine maleate, an enhancer of gastric mucosal protective factors, has demonstrated its efficacy for various gastric mucosal injuries. The aim of this study was to evaluate the efficacy and safety of irsogladine for prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin-induced peptic ulcer and gastritis.
METHODS:
In this multicenter, randomized, double-blind, exploratory clinical trial, 100 patients over 50 years of age who needed continuous NSAIDs or aspirin for more than 8 weeks were randomly assigned to either test group (irsogladine maleate 2 mg, twice daily, 39 patients for full analysis) or placebo group (37 patients for full analysis). Primary outcomes were incidence of peptic ulcer and ratio of modified Lanza score (MLS) 2 to 4. Secondary outcome was the number of acute erosions confirmed by endoscopy at 8 weeks. Adverse effects were also compared.
RESULTS:
There were no significant differences in gastric protective effects between test and placebo groups. However, two cases of peptic ulcer in the placebo group but none in the test group were observed. These two cases of peptic ulcer were Helicobacter pylori-negative. In addition, H. pylori-negative group showed significant changes in MLS score (p = 0.0247) and edema score (p = 0.0154) after the treatment compared to those before treatment in the test group. There was no significant difference in adverse events between the two groups.
CONCLUSIONS
The efficacy of irsogladine maleate was found in H. pylori-negative group, suggesting its potential as a protective agent against NSAIDs or aspirin-induced peptic ulcer and gastritis.
7.Factors Associated with Rebleeding in Patients with Peptic Ulcer Bleeding: Analysis of the Korean Peptic Ulcer Bleeding (K-PUB) Study.
Joon Sung KIM ; Byung Wook KIM ; Sung Min PARK ; Ki Nam SHIM ; Seong Woo JEON ; Sang Wook KIM ; Yong Chan LEE ; Hee Seok MOON ; Si Hyung LEE ; Woon Tae JUNG ; Jin Il KIM ; Kyoung Oh KIM ; Jong Jae PARK ; Woo Chul CHUNG ; Jeong Hwan KIM ; Gwang Ho BAIK ; Jung Hwan OH ; Sun Moon KIM ; Hyun Soo KIM ; Chang Heon YANG ; Jin Tae JUNG ; Chul Hyun LIM ; Hyun Joo SONG ; Yong Sik KIM ; Gwang Ha KIM ; Jie Hyun KIM ; Jae Il CHUNG ; Jun Haeng LEE ; Min Ho CHOI ; Jong Kyoung CHOI
Gut and Liver 2018;12(3):271-277
BACKGROUND/AIMS: Rebleeding is associated with mortality in patients with peptic ulcer bleeding (PUB), and risk stratification is important for the management of these patients. The purpose of our study was to examine the risk factors associated with rebleeding in patients with PUB. METHODS: The Korean Peptic Ulcer Bleeding registry is a large prospectively collected database of patients with PUB who were hospitalized between 2014 and 2015 at 28 medical centers in Korea. We examined the basic characteristics and clinical outcomes of patients in this registry. Univariate and multivariate analyses were performed to identify the factors associated with rebleeding. RESULTS: In total, 904 patients with PUB were registered, and 897 patients were analyzed. Rebleeding occurred in 7.1% of the patients (64), and the 30-day mortality was 1.0% (nine patients). According to the multivariate analysis, the risk factors for rebleeding were the presence of co-morbidities, use of multiple drugs, albumin levels, and hematemesis/hematochezia as initial presentations. CONCLUSIONS: The presence of co-morbidities, use of multiple drugs, albumin levels, and initial presentations with hematemesis/hematochezia can be indicators of rebleeding in patients with PUB. The wide use of proton pump inhibitors and prompt endoscopic interventions may explain the low incidence of rebleeding and low mortality rates in Korea.
Hemorrhage*
;
Humans
;
Incidence
;
Korea
;
Mortality
;
Multivariate Analysis
;
Peptic Ulcer Hemorrhage
;
Peptic Ulcer*
;
Prospective Studies
;
Proton Pump Inhibitors
;
Risk Factors
8.Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial.
Hyuk YOON ; Dong Ho LEE ; Yong Hyun LEE ; Ju Cheol JEONG ; Soo Teik LEE ; Myung Gyu CHOI ; Seong Woo JEON ; Ki Nam SHIM ; Gwang Ho BAIK ; Jae Gyu KIM ; Jeong Seop MOON ; In Kyung SUNG ; Sang Kil LEE ; Poong Lyul RHEE ; Hwoon Yong JUNG ; Bong Eun LEE ; Hyun Soo KIM ; Sang Gyun KIM ; Kee Myung LEE ; Jae Kyu SEONG ; Jin Seok JANG ; Jong Jae PARK
Gut and Liver 2018;12(5):516-522
BACKGROUND/AIMS: To evaluate the efficacy and safety of a controlled release, once-daily formulation of mosapride (UI05MSP015CT) in patients with functional dyspepsia (FD). METHODS: Patients with FD were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once a day, study group) or mosapride (5 mg three times a day, control group) and corresponding placebo for 4 weeks. The primary endpoint was a change in the gastrointestinal symptom score (GIS) evaluated at enrollment and after 4 weeks. Secondary endpoints were changes in the Nepean Dyspepsia Index-Korean version (NDI-K), rate of satisfactory symptom relief, and rate of adverse events. RESULTS: A total of 138 patients were enrolled (female, 73.9%; mean age, 44.0±15.4 years). After excluding patients who violated the study protocol, 59 and 58 patients from the study and control groups, respectively, were included in the per-protocol analysis. No difference was observed in drug compliance between the control and study groups (97.07%±4.52% vs 96.85%±6.05%, p=0.870). Changes in GIS scores were 9.69±6.44 and 10.01±5.92 in the study and control groups. The mean difference in GIS change between groups was 0.33 (95% confidence interval, 1.75 to 2.41), demonstrating non-inferiority of UI-05MSP015CT (p=0.755). The rate of satisfactory symptom relief was not different between the study and control groups (39.0% vs 56.9%, p=0.053). No differences in change in NDI-K score (14.3 vs 16.9, p=0.263) or rates of adverse events (12.9% vs. 4.4%, p=0.062) were observed between the study and control groups. CONCLUSIONS: Once-daily mosapride is not inferior to conventional mosapride in efficacy and is safe in patients with FD.
Compliance
;
Dyspepsia*
;
Humans
9.Changes in bioimpedance analysis components before and after hemodialysis.
Hyunsuk KIM ; Gwang Ho CHOI ; Kwang Eon SHIM ; Jung Hoon LEE ; Nam Ju HEO ; Kwon Wook JOO ; Jong Woo YOON ; Yun Kyu OH
Kidney Research and Clinical Practice 2018;37(4):393-403
BACKGROUND: This study compared nutritional parameters in hemodialysis (HD) subjects and controls using bioimpedance analysis (BIA) and investigated how BIA components changed before and after HD. METHODS: This cross-sectional study included 147 subjects on maintenance HD from two hospitals and 298 propensity score-matched controls from one healthcare center. BIA was performed pre- and post-HD at mid-week dialysis sessions. RESULTS: Extracellular water/total body water (ECW/TBW) and waist-hip ratio were higher in the HD patients; the other variables were higher in the control group. The cardiothoracic ratio correlated best with overhydration (r = 0.425, P < 0.01) in HD subjects. Blood pressure, hemoglobin, creatinine, and uric acid positively correlated with the lean tissue index in controls; however, most of these nutritional markers did not show significant correlations in HD subjects. Normal hydrated weight was predicted to be higher in the pre-HD than post-HD measurements. Predicted ultrafiltration (UF) volume difference based on pre- and post-HD ECW/TBW and measured UF volume difference showed a close correlation (r 2 = 0.924, P < 0.01). Remarkably, the leg phase angle increased in the post-HD period. CONCLUSION: The estimated normal hydrated weight using ECW/TBW can be a good marker for determining dry weight. HD subjects had higher ECW/TBW but most nutritional indices were inferior to those of controls. It was possible to predict UF volume differences using BIA, but the post-HD increase in leg phase angle, a nutritional marker, must be interpreted with caution.
Blood Pressure
;
Body Water
;
Creatinine
;
Cross-Sectional Studies
;
Delivery of Health Care
;
Dialysis
;
Humans
;
Leg
;
Nutrition Assessment
;
Nutritional Status
;
Renal Dialysis*
;
Ultrafiltration
;
Uric Acid
;
Waist-Hip Ratio
10.Female Gender is a Poor Predictive Factor of Functional Dyspepsia Resolution after Helicobacter pylori Eradication: A Prospective, Multi-center Korean Trial.
Sung Eun KIM ; Nayoung KIM ; Seon Mee PARK ; Won Hee KIM ; Gwang Ho BAIK ; Yunju JO ; Kyung Sik PARK ; Ju Yup LEE ; Ki Nam SHIM ; Gwang Ha KIM ; Bong Eun LEE ; Su Jin HONG ; Seon Young PARK ; Suck Chei CHOI ; Jung Hwan OH ; Hyun Jin KIM
The Korean Journal of Gastroenterology 2018;72(6):286-294
BACKGROUND/AIMS: The predictive factors of functional dyspepsia (FD) remain controversial. Therefore, we sought to investigate symptom responses in FD patients after Helicobacter pylori (H. pylori) eradication and used predictive factor analysis to identify significant factors of FD resolution at one-year after commencing eradication therapy. METHODS: This prospective, multi-center clinical trial was performed on 65 FD patients that met Rome III criteria and had H. pylori infection. Symptom responses and factors that predicted poor response were determined by analysis one year after commencing H. pylori eradication therapy. RESULTS: A total of 63 patients completed the one-year follow-up. When an eradication success group (n=60) and an eradication failure group (n=3) were compared with respect to FD response rate at one year, results were as follows; complete response 73.3% and 0.0%, satisfactory response 1.7% and 0.0%, partial response 10.0% and 33.3%, and refractory response 15.0% and 66.7%, respectively (p=0.013). Univariate analysis showed persistent H. pylori infection (p=0.021), female gender (p=0.025), and medication for FD during the study period (p=0.013) were associated with poor FD response at one year. However, age, smoking, alcohol consumption, and underlying disease were not found to affect response. Finally, multivariate analysis showed that female gender (OR, 4.70; 95% CI, 1.17-18.88) was the sole independent risk factor of poor FD response at one year after commencing H. pylori eradication therapy. CONCLUSIONS: Female gender was found to predict poor response in FD patients despite H. pylori eradication. Furthermore, successful H. pylori eradication appears to be associated with FD improvement, but the number of non-eradicated patients was too small to conclude.
Alcohol Drinking
;
Dyspepsia*
;
Female*
;
Follow-Up Studies
;
Helicobacter pylori*
;
Helicobacter*
;
Humans
;
Multivariate Analysis
;
Prospective Studies*
;
Risk Factors
;
Smoke
;
Smoking
;
Symptom Assessment

Result Analysis
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