1.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
2.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
3.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
4.The Clinical Impact of β-Blocker Therapy on Patients With Chronic Coronary Artery Disease After Percutaneous Coronary Intervention
Jiesuck PARK ; Jung-Kyu HAN ; Jeehoon KANG ; In-Ho CHAE ; Sung Yun LEE ; Young Jin CHOI ; Jay Young RHEW ; Seung-Woon RHA ; Eun-Seok SHIN ; Seong-Ill WOO ; Han Cheol LEE ; Kook-Jin CHUN ; DooIl KIM ; Jin-Ok JEONG ; Jang-Whan BAE ; Han-Mo YANG ; Kyung Woo PARK ; Hyun-Jae KANG ; Bon-Kwon KOO ; Hyo-Soo KIM
Korean Circulation Journal 2022;52(7):544-555
Background and Objectives:
The outcome benefits of β-blockers in chronic coronary artery disease (CAD) have not been fully assessed. We evaluated the prognostic impact of β-blockers on patients with chronic CAD after percutaneous coronary intervention (PCI).
Methods:
A total of 3,075 patients with chronic CAD were included from the Grand DrugEluting Stent registry. We analyzed β-blocker prescriptions, including doses and types, in each patient at 3-month intervals from discharge. After propensity score matching, 1,170 pairs of patients (β-blockers vs. no β-blockers) were derived. Primary outcome was defined as a composite endpoint of all-cause death and myocardial infarction (MI). We further analyzed the outcome benefits of different doses (low-, medium-, and high-dose) and types (conventional or vasodilating) of β-blockers.
Results:
During a median (interquartile range) follow-up of 3.1 (3.0–3.1) years, 134 (5.7%) patients experienced primary outcome. Overall, β-blockers demonstrated no significant benefit in primary outcome (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.63–1.24), all-cause death (HR, 0.87; 95% CI, 0.60–1.25), and MI (HR, 1.25; 95% CI, 0.49–3.15). In subgroup analysis, β-blockers were associated with a lower risk of all-cause death in patients with previous MI and/ or revascularization (HR, 0.38; 95% CI, 0.14–0.99) (p for interaction=0.045). No significant associations were found for the clinical outcomes with different doses and types of β-blockers.
Conclusions
Overall, β-blocker therapy was not associated with better clinical outcomes in patients with chronic CAD undergoing PCI. Limited mortality benefit of β-blockers may exist for patients with previous MI and/or revascularization.
5.Anti-cancer Activity of Anthricin through Caspase-dependent Apoptosis in Human Hypopharyngeal Squamous Carcinoma Cell.
Won Gi KIM ; Seul Ah LEE ; Sung Min MOON ; Jin Soo KIM ; Su Gwan KIM ; Yong Kook SHIN ; Do Kyung KIM ; Chun Sung KIM
International Journal of Oral Biology 2016;41(4):183-190
Anthricin (Deoxypodophyllotoxin), a naturally occurring flavolignan, has well known anti-cancer properties in several cancer cells, such as prostate cancer, cervical carcinoma and pancreatic cancer. However, the effects of Anthricin are currently unknown in oral cancer. We examined the anti-cancer effect and mechanism of action of Anthricin in human FaDu hypopharyngeal squamous carcinoma cells. Our data showed that Anthricin inhibits cell viability in a dose- and time-dependent manner (IC50 50 nM) in the MTT assay and Live & Dead assay. In addition, Anthricin treated FaDu cells showed marked apoptosis by DAPI stain and FACS. Furthermore, Anthricin activates anti-apoptotic factors such as caspase-3, -9 and poly (ADP-ribose) polymerase (PARP), suggesting that caspase-mediated pathways are involved in Anthricin-induced apoptosis. Anthricin treatment also leads to accumulation of the pro-apoptotic factor Bax, followed by inhibition of cell growth. Taken together, these results indicate that Anthricn-induced cell death of human FaDu hypopharyngeal squamous carcinoma cells is mediated by mitochondrial-dependent apoptotic pathway. In summary, our findings provide a framework for further exploration on Anthricin as a novel chemotherapeutic drug for human oral cancer.
Apoptosis*
;
Carcinoma, Squamous Cell*
;
Caspase 3
;
Cell Death
;
Cell Survival
;
Humans*
;
Mouth Neoplasms
;
Pancreatic Neoplasms
;
Prostatic Neoplasms
6.Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia.
Myung Gyu CHOI ; Poong Lyul RHEE ; Hyojin PARK ; Oh Young LEE ; Kwang Jae LEE ; Suck Chei CHOI ; Sang Young SEOL ; Hoon Jai CHUN ; Jong Sun REW ; Dong Ho LEE ; Geun Am SONG ; Hwoon Yong JUNG ; Hyung Yong JEONG ; In Kyung SUNG ; Joon Seong LEE ; Soo Teik LEE ; Sung Kook KIM ; Yong Woon SHIN
Journal of Neurogastroenterology and Motility 2015;21(3):414-422
BACKGROUND/AIMS: Therapies of functional dyspepsia (FD) are limited. DA-9701 is a novel prokinetic agent formulated with Pharbitis semen and Corydalis Tuber. We aimed to assess the efficacy of DA-9701 compared with itopride in FD patients. METHODS: Patients with FD randomly received either itopride 50 mg or DA-9701 30 mg t.i.d after a 2-week baseline period. After 4 weeks of treatment, 2 primary efficacy endpoints were analyzed: the change from baseline in composite score of the 8 dyspeptic symptoms and the overall treatment effect. Impact on patients' quality of life was assessed using the Nepean Dyspepsia Index (NDI) questionnaire. RESULTS: We randomly assigned 464 patients with 455 having outcome data. The difference of the composite score change of the 8 symptoms between the 2 groups was 0.62, indicating that DA-9701 was not inferior to itopride. The overall treatment effect response rate was not different between the groups. When responder was defined as > or = 5 of the 7 Likert scale, responder rates were 37% of DA-9701 and 36% of itopride group. Patients receiving DA-9701 experienced similar mean percentage of days with adequate relief during the 4-week treatment period compared with those receiving itopride (56.8% vs 59.1%). Both drugs increased the NDI score of 5 domains without any difference in change of the NDI score between the groups. The safety profile of both drugs was comparable. CONCLUSIONS: DA-9701 significantly improves symptoms in patients with FD. DA-9701 showed non-inferior efficacy to itopride with comparable safety.
Corydalis
;
Dyspepsia*
;
Humans
;
Quality of Life
;
Surveys and Questionnaires
;
Semen
7.Associations of Colorectal Cancer Incidence with Nutrient and Food Group Intakes in Korean Adults: A Case-Control Study.
Yu Jeong CHUN ; Seung Kook SOHN ; Hye Kyung SONG ; Song Mi LEE ; Young Hoon YOUN ; Seungmin LEE ; Hyojin PARK
Clinical Nutrition Research 2015;4(2):110-123
This study aimed to examine the associations between intakes of various nutrients and food groups and colorectal cancer risk in a case-control study among Koreans aged 20 to 80 years. A total of 150 new cases and 116 controls were recruited with subjects' informed consent. Dietary data were collected using the food frequency questionnaire developed and validated by the Korea Centers for Disease Control and Prevention. Multivariate logistic regression models were used to estimate odds ratios (ORs) and corresponding 95% confidence intervals (CIs) for colorectal cancer incidence. High intakes of total lipid (OR(T3 vs T1) = 4.15, 95% CI: 1.33-12.96, p for trend = 0.034), saturated fatty acid (OR(T3 vs T1) = 2.96, 95% CI: 1.24-7.04, p for trend = 0.016) and monounsaturated fatty acid (OR(T3 vs T1) = 3.04, 95% CI: 1.23-7.54, p for trend = 0.018) were significantly associated with increased incidence of colorectal cancer. High dietary fiber (OR(T3 vs T1) = 0.22, 95% CI: 0.08-0.56, p for trend = 0.002) and vitamin C (OR(T3 vs T1) = 0.38, 95% CI: 0.14-1.05, p for trend = 0.021) intakes were significantly associated with reduced colorectal cancer incidence. From the food group analysis, bread (OR(T3 vs T1) = 2.26, 95% CI: 0.96-5.33, p for trend = 0.031), red meat (OR(T3 vs T1) = 7.33, 95% CI: 2.98-18.06, p for trend < 0.001), milk.dairy product (OR(T3 vs T1) = 2.42, 95% CI: 1.10-5.31, p for trend = 0.071) and beverage (OR(T3 vs T1) = 3.17, 95% CI: 1.35-7.48, p for trend = 0.002) intakes were positively associated with colorectal cancer risk. On the other hand, high intake of traditional rice cake (OR(T3 vs T1) = 0.35, 95% CI: 0.14-0.86, p for trend = 0.024) was linked with lower colorectal cancer incidence. In conclusion, eating a diet high in total lipid, saturated fatty acids and monounsaturated fatty acids is associated with higher incidence of colorectal cancer, whereas a diet high in dietary fiber and vitamin C was found to lower the incidence in Korean adults. Interestingly high traditional rice cake consumption is associated inversely with colorectal cancer incidence, warranting a future study.
Adult*
;
Ascorbic Acid
;
Beverages
;
Bread
;
Case-Control Studies*
;
Centers for Disease Control and Prevention (U.S.)
;
Colorectal Neoplasms*
;
Diet
;
Dietary Fiber
;
Eating
;
Fatty Acids
;
Fatty Acids, Monounsaturated
;
Hand
;
Humans
;
Incidence*
;
Informed Consent
;
Korea
;
Logistic Models
;
Meat
;
Odds Ratio
;
Surveys and Questionnaires
8.Effects of Organizational Injustice on Negative Behaviors of Employees: Focusing on the Mediating Effect of Trust.
Journal of Korean Academy of Nursing Administration 2014;20(1):59-68
PURPOSE: The purpose of this research was to delineate the effects of organizational injustice on negative behaviors of employees with the mediating effects of trust. METHODS: A survey was conducted among 550 nurses in 11 departments of 3 hospitals located in the Pohang area. Data were analyzed using frequency, descriptive statistics. correlation coefficients, regression analysis. RESULTS: Procedural injustice (beta=-.48, p<.001) had the greatest negative effect on organizational trust, followed by interactional injustice(beta=-.15, p<.001) and distributive injustice(beta=-.14, p<.001). For supervisor trust, both procedural (beta=-.11, p=.006) and interactional (beta=-.63, p<.001) injustice had a negative effect. While supervisor trust (beta=-.28, p<.001) had greater negative effects on organizational negative behaviors of nurses compared to organizational trust (beta=-.21, p<.001), supervisor trust (beta=-.29, p<.001) had negative effects on personal negative behaviors but organizational trust had no significant effect on personal negative behaviors. CONCLUSION: To reduce the negative organizational behaviors of nurses, an organizational effort is needed to reduce procedural injustice by introducing fair organizational management and to reduce interactional injustice through formal or informal communication channels between supervisors and nurses.
Gyeongsangbuk-do
;
Humans
;
Negotiating*
9.Initial Laboratory Parameters and its Correlation to Intermediate Syndrome in Patients with Acute Organophosphate Poisoning.
Wang Ki LEE ; Byeong Jo CHUN ; Joeng Mi MOON ; Seung Min LEE ; Yong Hun JUNG ; Byung Kook LEE ; Hyun Ho RYU ; Kyung Woon JEUNG ; Tag HEO ; Yong Il MIN
Journal of the Korean Society of Emergency Medicine 2013;24(5):557-565
PURPOSE: The association of serial serum cholinesterase (SChE) activity and the occurrence of intermediate syndrome (IMS) in patients orally poisoned with organophosphate (OP) were investigated. In addition, other clinical and laboratory factors were assessed for their ability to predict the subsequent development of IMS. METHODS: A total of 114 patients presented to our emergency department with acute OP ingestion between 2007 and 2012 were enrolled in this prospective study. Of these patients, 67 who needed mechanical ventilation (MV) over five days were divided into the IMS group. The 47 patients weaned from MV within four days after admission, or who did not receive the assistance of MV, were placed in the non-IMS group. The level of SChE at admission, 48 hours, and 96 hours, at discharge after admission were checked. The APACHE II (Acute Physiology, Age, Chronic Health Evaluation II) score, the amount ingested, exposure route, gender, age, and the laboratory test results were collected. All statistical analyses were performed using the Statistical Package for the Social Sciences (version 20.0). RESULTS: The mean age of total enrolled patients was 53.7+/-17.9 years and 73 patients (64.0% of total patients) were male. There were 102(89.5%) patients who intentionally ingested the OP and the mean amount ingested was 102.5+/-64.9 mL. The mean time after patients sought medical care was 5.4+/-10.5 hours after ingestion. The level of SChE at admission was 1,586+/-796 U/L and the APACHE II score was 28.81+/-19.7. The arterial pH, bicarbonate and carbon dioxide pressure, and serum protein and albumin were significantly lower in the IMS group than the non-IMS group (p<0.001). In contrast, the serum amylase, lipase, and glucose were higher in the IMS group. The APACHE II score, serum albumin and amylase, arterial bicarbonate, and the SChE at 48 and 96 hours after ingestion were independent factors that predicted the occurrence of IMS in patients with OP poisoning. The rate of recovery was 86.6% in the IMS group and 100% in the non-IMS group (p<0.001). CONCLUSION: Patients with a higher APACHE II score and levels of serum amylase, and lower levels of serum albumin and arterial bicarbonate, may be associated with the occurrence of IMS. Furthermore, when SChE levels after 48 hours and 96 hours did not increase, compared with the level of SChE at admission, patients tended to show IMS.
Amylases
;
APACHE
;
Carbon Dioxide
;
Cholinesterases
;
Eating
;
Emergencies
;
Glucose
;
Humans
;
Hydrogen-Ion Concentration
;
Intention
;
Lipase
;
Male
;
Organophosphate Poisoning*
;
Physiology
;
Poisoning
;
Prospective Studies
;
Respiration, Artificial
;
Serum Albumin
;
Social Sciences
10.Initial Laboratory Parameters and its Correlation to Intermediate Syndrome in Patients with Acute Organophosphate Poisoning.
Wang Ki LEE ; Byeong Jo CHUN ; Joeng Mi MOON ; Seung Min LEE ; Yong Hun JUNG ; Byung Kook LEE ; Hyun Ho RYU ; Kyung Woon JEUNG ; Tag HEO ; Yong Il MIN
Journal of the Korean Society of Emergency Medicine 2013;24(5):557-565
PURPOSE: The association of serial serum cholinesterase (SChE) activity and the occurrence of intermediate syndrome (IMS) in patients orally poisoned with organophosphate (OP) were investigated. In addition, other clinical and laboratory factors were assessed for their ability to predict the subsequent development of IMS. METHODS: A total of 114 patients presented to our emergency department with acute OP ingestion between 2007 and 2012 were enrolled in this prospective study. Of these patients, 67 who needed mechanical ventilation (MV) over five days were divided into the IMS group. The 47 patients weaned from MV within four days after admission, or who did not receive the assistance of MV, were placed in the non-IMS group. The level of SChE at admission, 48 hours, and 96 hours, at discharge after admission were checked. The APACHE II (Acute Physiology, Age, Chronic Health Evaluation II) score, the amount ingested, exposure route, gender, age, and the laboratory test results were collected. All statistical analyses were performed using the Statistical Package for the Social Sciences (version 20.0). RESULTS: The mean age of total enrolled patients was 53.7+/-17.9 years and 73 patients (64.0% of total patients) were male. There were 102(89.5%) patients who intentionally ingested the OP and the mean amount ingested was 102.5+/-64.9 mL. The mean time after patients sought medical care was 5.4+/-10.5 hours after ingestion. The level of SChE at admission was 1,586+/-796 U/L and the APACHE II score was 28.81+/-19.7. The arterial pH, bicarbonate and carbon dioxide pressure, and serum protein and albumin were significantly lower in the IMS group than the non-IMS group (p<0.001). In contrast, the serum amylase, lipase, and glucose were higher in the IMS group. The APACHE II score, serum albumin and amylase, arterial bicarbonate, and the SChE at 48 and 96 hours after ingestion were independent factors that predicted the occurrence of IMS in patients with OP poisoning. The rate of recovery was 86.6% in the IMS group and 100% in the non-IMS group (p<0.001). CONCLUSION: Patients with a higher APACHE II score and levels of serum amylase, and lower levels of serum albumin and arterial bicarbonate, may be associated with the occurrence of IMS. Furthermore, when SChE levels after 48 hours and 96 hours did not increase, compared with the level of SChE at admission, patients tended to show IMS.
Amylases
;
APACHE
;
Carbon Dioxide
;
Cholinesterases
;
Eating
;
Emergencies
;
Glucose
;
Humans
;
Hydrogen-Ion Concentration
;
Intention
;
Lipase
;
Male
;
Organophosphate Poisoning*
;
Physiology
;
Poisoning
;
Prospective Studies
;
Respiration, Artificial
;
Serum Albumin
;
Social Sciences

Result Analysis
Print
Save
E-mail