1.A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease
Su Hyun PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung Gyu CHOI ; Jie-Hyun KIM ; In-Kyung SUNG ; Jae Young JANG ; Kyung Sik PARK ; Hoon Jai CHUN ; Eun Young KIM ; Jun Kyu LEE ; Jin Seok JANG ; Gwang Ha KIM ; Su Jin HONG ; Yong Chan LEE ; Suck-Chei CHOI ; Hyun Soo KIM ; Tae Oh KIM ; Gwang Ho BAIK ; Yong Cheol JEON
Gut and Liver 2023;17(2):226-233
Background/Aims:
Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone.
Methods:
This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either EsoduoⓇ/sup> (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ/sup> (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4.
Results:
A total of 355 patients completed the study (180 in the EsoduoⓇ/sup> group and 175 in the NexiumⓇ/sup> group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the EsoduoⓇ/sup> group and 35% in the NexiumⓇ/sup> group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles.
Conclusions
EsoduoⓇ/sup> is as effective and safe as NexiumⓇ/sup> for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).
2.2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease
Hye-Kyung JUNG ; Chung Hyun TAE ; Kyung Ho SONG ; Seung Joo KANG ; Jong Kyu PARK ; Eun Jeong GONG ; Jeong Eun SHIN ; Hyun Chul LIM ; Sang Kil LEE ; Da Hyun JUNG ; Yoon Jin CHOI ; Seung In SEO ; Joon Sung KIM ; Jung Min LEE ; Beom Jin KIM ; Sun Hyung KANG ; Chan Hyuk PARK ; Suck Chei CHOI ; Joong Goo KWON ; Kyung Sik PARK ; Moo In PARK ; Tae Hee LEE ; Seung Young KIM ; Young Sin CHO ; Han Hong LEE ; Kee Wook JUNG ; Do Hoon KIM ; Hee Seok MOON ; Mi-Young CHOI ; Kwang Jae LEE ;
Korean Journal of Medicine 2022;97(2):70-92
Gastroesophageal reflux disease (GERD) is a condition in which gastric contents regurgitate into the esophagus or beyond, resulting in either troublesome symptoms or complications. GERD is heterogeneous in terms of varied manifestations, test findings, and treatment responsiveness. GERD diagnosis can be established with symptomatology, pathology, or physiology. Recently the Lyon consensus defined the “proven GERD” with concrete evidence for reflux, including advanced grade erosive esophagitis (Los Angeles classification grades C and or D esophagitis), long-segment Barrett’s mucosa or peptic strictures on endoscopy or distal esophageal acid exposure time > 6% on 24-hour ambulatory pH-impedance monitoring. However, some Asian researchers have different opinions on whether the same standards should be applied to the Asian population. The prevalence of GERD is increasing in Asia. The present evidence-based guidelines were developed using a systematic review and meta-analysis approach. In GERD with typical symptoms, a proton pump inhibitor test can be recommended as a sensitive, cost-effective, and practical test for GERD diagnosis. Based on a meta-analysis of 19 estimated acid-exposure time values in Asians, the reference range upper limit for esophageal acid exposure time was 3.2% (95% confidence interval 2.7-3.9%) in the Asian countries. Esophageal manometry and novel impedance measurements, including mucosal impedance and a post-reflux swallow-induced peristaltic wave, are promising in discrimination of GERD among different reflux phenotypes, thus increasing its diagnostic yield. We also propose a long-term strategy of evidence-based GERD treatment with proton pump inhibitors and other drugs.
3.2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease
Hye-Kyung JUNG ; Chung Hyun TAE ; Kyung Ho SONG ; Seung Joo KANG ; Jong Kyu PARK ; Eun Jeong GONG ; Jeong Eun SHIN ; Hyun Chul LIM ; Sang Kil LEE ; Da Hyun JUNG ; Yoon Jin CHOI ; Seung In SEO ; Joon Sung KIM ; Jung Min LEE ; Beom Jin KIM ; Sun Hyung KANG ; Chan Hyuk PARK ; Suck Chei CHOI ; Joong Goo KWON ; Kyung Sik PARK ; Moo In PARK ; Tae Hee LEE ; Seung Young KIM ; Young Sin CHO ; Han Hong LEE ; Kee Wook JUNG ; Do Hoon KIM ; Hee Seok MOON ; Hirota MIWA ; Chien-Lin CHEN ; Sutep GONLACHANVIT ; Uday C GHOSHAL ; Justin C Y WU ; Kewin T H SIAH ; Xiaohua HOU ; Tadayuki OSHIMA ; Mi-Young CHOI ; Kwang Jae LEE ; The Korean Society of Neurogastroenterology and Motility
Journal of Neurogastroenterology and Motility 2021;27(4):453-481
Gastroesophageal reflux disease (GERD) is a condition in which gastric contents regurgitate into the esophagus or beyond, resulting in either troublesome symptoms or complications. GERD is heterogeneous in terms of varied manifestations, test findings, and treatment responsiveness. GERD diagnosis can be established with symptomatology, pathology, or physiology. Recently the Lyon consensus defined the “proven GERD” with concrete evidence for reflux, including advanced grade erosive esophagitis (Los Angeles classification grades C and or D esophagitis), long-segment Barrett’s mucosa or peptic strictures on endoscopy or distal esophageal acid exposure time > 6% on 24-hour ambulatory pH-impedance monitoring. However, some Asian researchers have different opinions on whether the same standards should be applied to the Asian population. The prevalence of GERD is increasing in Asia. The present evidence-based guidelines were developed using a systematic review and meta-analysis approach. In GERD with typical symptoms, a proton pump inhibitor test can be recommended as a sensitive, cost-effective, and practical test for GERD diagnosis.Based on a meta-analysis of 19 estimated acid-exposure time values in Asians, the reference range upper limit for esophageal acid exposure time was 3.2% (95% confidence interval, 2.7-3.9%) in the Asian countries. Esophageal manometry and novel impedance measurements, including mucosal impedance and a post-reflux swallow-induced peristaltic wave, are promising in discrimination of GERD among different reflux phenotypes, thus increasing its diagnostic yield. We also propose a long-term strategy of evidence-based GERD treatment with proton pump inhibitors and other drugs.
4.2020 Seoul Consensus on the Diagnosis and Management of Gastroesophageal Reflux Disease
Hye-Kyung JUNG ; Chung Hyun TAE ; Kyung Ho SONG ; Seung Joo KANG ; Jong Kyu PARK ; Eun Jeong GONG ; Jeong Eun SHIN ; Hyun Chul LIM ; Sang Kil LEE ; Da Hyun JUNG ; Yoon Jin CHOI ; Seung In SEO ; Joon Sung KIM ; Jung Min LEE ; Beom Jin KIM ; Sun Hyung KANG ; Chan Hyuk PARK ; Suck Chei CHOI ; Joong Goo KWON ; Kyung Sik PARK ; Moo In PARK ; Tae Hee LEE ; Seung Young KIM ; Young Sin CHO ; Han Hong LEE ; Kee Wook JUNG ; Do Hoon KIM ; Hee Seok MOON ; Hirota MIWA ; Chien-Lin CHEN ; Sutep GONLACHANVIT ; Uday C GHOSHAL ; Justin C Y WU ; Kewin T H SIAH ; Xiaohua HOU ; Tadayuki OSHIMA ; Mi-Young CHOI ; Kwang Jae LEE ; The Korean Society of Neurogastroenterology and Motility
Journal of Neurogastroenterology and Motility 2021;27(4):453-481
Gastroesophageal reflux disease (GERD) is a condition in which gastric contents regurgitate into the esophagus or beyond, resulting in either troublesome symptoms or complications. GERD is heterogeneous in terms of varied manifestations, test findings, and treatment responsiveness. GERD diagnosis can be established with symptomatology, pathology, or physiology. Recently the Lyon consensus defined the “proven GERD” with concrete evidence for reflux, including advanced grade erosive esophagitis (Los Angeles classification grades C and or D esophagitis), long-segment Barrett’s mucosa or peptic strictures on endoscopy or distal esophageal acid exposure time > 6% on 24-hour ambulatory pH-impedance monitoring. However, some Asian researchers have different opinions on whether the same standards should be applied to the Asian population. The prevalence of GERD is increasing in Asia. The present evidence-based guidelines were developed using a systematic review and meta-analysis approach. In GERD with typical symptoms, a proton pump inhibitor test can be recommended as a sensitive, cost-effective, and practical test for GERD diagnosis.Based on a meta-analysis of 19 estimated acid-exposure time values in Asians, the reference range upper limit for esophageal acid exposure time was 3.2% (95% confidence interval, 2.7-3.9%) in the Asian countries. Esophageal manometry and novel impedance measurements, including mucosal impedance and a post-reflux swallow-induced peristaltic wave, are promising in discrimination of GERD among different reflux phenotypes, thus increasing its diagnostic yield. We also propose a long-term strategy of evidence-based GERD treatment with proton pump inhibitors and other drugs.
5.Clinical Characteristics of Chronic Cough in Korea
Tai Joon AN ; Jin Woo KIM ; Eun Young CHOI ; Seung Hun JANG ; Hwa Young LEE ; Hye Seon KANG ; Hyeon Kyoung KOO ; Jong Min LEE ; Sung Kyung KIM ; Jong Wook SHIN ; So Young PARK ; Chin Kook RHEE ; Ji Yong MOON ; Yee Hyung KIM ; Hyun LEE ; Yong Hyun KIM ; Je Hyeong KIM ; Sang Haak LEE ; Deog Kyeom KIM ; Kwang Ha YOO ; Dong Gyu KIM ; Ki Suck JUNG ; Hui Jung KIM ; Hyoung Kyu YOON ;
Tuberculosis and Respiratory Diseases 2020;83(1):31-41
6.Clinical Characteristics of Chronic Cough in Korea
Tai Joon AN ; Jin Woo KIM ; Eun Young CHOI ; Seung Hun JANG ; Hwa Young LEE ; Hye Seon KANG ; Hyeon Kyoung KOO ; Jong Min LEE ; Sung Kyung KIM ; Jong Wook SHIN ; So Young PARK ; Chin Kook RHEE ; Ji Yong MOON ; Yee Hyung KIM ; Hyun LEE ; Yong Hyun KIM ; Je Hyeong KIM ; Sang Haak LEE ; Deog Kyeom KIM ; Kwang Ha YOO ; Dong Gyu KIM ; Ki Suck JUNG ; Hui Jung KIM ; Hyoung Kyu YOON ;
Tuberculosis and Respiratory Diseases 2020;83(1):31-41
BACKGROUND:
Chronic cough is defined as a cough lasting more than 8 weeks and socio-economic burden of chronic cough is enormous. The characteristics of chronic cough in Korea are not well understood. The Korean Academy of Tuberculosis and Respiratory Diseases (KATRD) published guidelines on cough management in 2014. The current study evaluated the clinical characteristics of chronic cough in Korea and the efficacy of the KATRD guidelines.
METHODS:
This was a multi-center, retrospective observational study conducted in Korea. The participants were over 18 years of age. They had coughs lasting more than 8 weeks. Subjects with current pulmonary diseases, smokers, ex-smokers with more than 10 pack-years or who quit within the past 1 year, pregnant women, and users of cough-inducing medications were excluded. Evaluation and management of cough followed the KATRD cough-management guidelines.
RESULTS:
Participants with chronic cough in Korea showed age in the late forties and cough duration of more than 1 year. Upper airway cough syndrome was the most common cause of cough, followed by cough-variant asthma (CVA). Gastro-esophageal reflux diseases and eosinophilic bronchitis were less frequently observed. Following the KATRD cough-management guidelines, 91.2% of the subjects improved after 4 weeks of treatment. Responders were younger, had a longer duration of cough, and an initial impression of CVA. In univariate and multivariate analyses, an initial impression of CVA was the only factor related to better treatment response.
CONCLUSION
The causes of chronic cough in Korea differed from those reported in other countries. The current Korean guidelines proved efficient for treating Korean patients with chronic cough.
7.Clinical Characteristics of Chronic Cough in Korea
Tai Joon AN ; Jin Woo KIM ; Eun Young CHOI ; Seung Hun JANG ; Hwa Young LEE ; Hye Seon KANG ; Hyeon Kyoung KOO ; Jong Min LEE ; Sung Kyung KIM ; Jong Wook SHIN ; So Young PARK ; Chin Kook RHEE ; Ji Yong MOON ; Yee Hyung KIM ; Hyun LEE ; Yong Hyun KIM ; Je Hyeong KIM ; Sang Haak LEE ; Deog Kyeom KIM ; Kwang Ha YOO ; Dong Gyu KIM ; Ki Suck JUNG ; Hui Jung KIM ; Hyoung Kyu YOON ;
Tuberculosis and Respiratory Diseases 2020;83(1):31-41
BACKGROUND:
Chronic cough is defined as a cough lasting more than 8 weeks and socio-economic burden of chronic cough is enormous. The characteristics of chronic cough in Korea are not well understood. The Korean Academy of Tuberculosis and Respiratory Diseases (KATRD) published guidelines on cough management in 2014. The current study evaluated the clinical characteristics of chronic cough in Korea and the efficacy of the KATRD guidelines.
METHODS:
This was a multi-center, retrospective observational study conducted in Korea. The participants were over 18 years of age. They had coughs lasting more than 8 weeks. Subjects with current pulmonary diseases, smokers, ex-smokers with more than 10 pack-years or who quit within the past 1 year, pregnant women, and users of cough-inducing medications were excluded. Evaluation and management of cough followed the KATRD cough-management guidelines.
RESULTS:
Participants with chronic cough in Korea showed age in the late forties and cough duration of more than 1 year. Upper airway cough syndrome was the most common cause of cough, followed by cough-variant asthma (CVA). Gastro-esophageal reflux diseases and eosinophilic bronchitis were less frequently observed. Following the KATRD cough-management guidelines, 91.2% of the subjects improved after 4 weeks of treatment. Responders were younger, had a longer duration of cough, and an initial impression of CVA. In univariate and multivariate analyses, an initial impression of CVA was the only factor related to better treatment response.
CONCLUSION
The causes of chronic cough in Korea differed from those reported in other countries. The current Korean guidelines proved efficient for treating Korean patients with chronic cough.
8.Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation
So Ryoung LEE ; Young Soo LEE ; Ji Suck PARK ; Myung Jin CHA ; Tae Hoon KIM ; Junbeom PARK ; Jin Kyu PARK ; Jung Myung LEE ; Ki Woon KANG ; Jaemin SHIM ; Jae Sun UHM ; Jun KIM ; Changsoo KIM ; Jin Bae KIM ; Hyung Wook PARK ; Boyoung JOUNG ; Eue Keun CHOI
Yonsei Medical Journal 2019;60(3):277-284
PURPOSE: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. MATERIALS AND METHODS: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on- or off-label use according to Korea Food and Drug Regulations. RESULTS: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2%, rivaroxaban 23.9%, apixaban 36.9%, and edoxaban 12.0%). The mean age was 70.5±9.2 years; 56.0% were men; and the mean CHA₂DS₂-VASc score was 3.3±1.4. Only one-third of the patients (32.7%) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4%) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinine clearance ≤50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. CONCLUSION: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.
Anticoagulants
;
Asian Continental Ancestry Group
;
Atrial Fibrillation
;
Body Weight
;
Cohort Studies
;
Drug and Narcotic Control
;
Drug Labeling
;
Female
;
Hemorrhage
;
Humans
;
Hypertension
;
Korea
;
Male
;
Off-Label Use
;
Prescriptions
;
Prospective Studies
;
Risk Factors
;
Rivaroxaban
;
Stroke
9.Clinical Features and Awareness of Hand Eczema in Korea.
Jae Beom PARK ; Seung Ho LEE ; Kea Jeung KIM ; Ga Young LEE ; Jun Mo YANG ; Do Won KIM ; Seok Jong LEE ; Cheol Heon LEE ; Eun Joo PARK ; Kyu Han KIM ; Hee Chul EUN ; Sung Eun CHANG ; Kee Chan MOON ; Seong Hyun KIM ; Seong Jin KIM ; Byung Soo KIM ; Jun Young LEE ; Hyung Ok KIM ; Hoon KANG ; Min Geol LEE ; Soo Chan KIM ; Young Suck RO ; Joo Yeon KO ; Mi Youn PARK ; Myung Hwa KIM ; Jeong Hyun SHIN ; Hae Young CHOI ; Chang Kwun HONG ; Sung Yul LEE ; Hana BAK ; Sang Wook SON ; Ai Young LEE
Annals of Dermatology 2016;28(3):335-343
BACKGROUND: Hand eczema is one of the most common skin disorders and negatively affects quality of life. However, a large-scale multicenter study investigating the clinical features of patients with hand eczema has not yet been conducted in Korea. OBJECTIVE: To identify the prevalence of various hand diseases, which is defined as all cutaneous disease occurring in hands, and to investigate the clinical features of patients with hand eczema and the awareness about hand eczema in the general population and to compare the prevalence of hand eczema between health care providers and non-health care providers. METHODS: To estimate the prevalence of hand diseases, we analyzed the medical records of patients from 24 medical centers. Patients were assessed by online and offline questionnaires. A 1,000 from general population and 913 hand eczema patients answered the questionnaire, for a total of 1,913 subjects. RESULTS: The most common hand disease was irritant contact dermatitis. In an online survey, the lifetime prevalence of hand eczema was 31.2%. Hand eczema was more likely to occur in females (66.0%) and younger (20~39 years, 53.9%). Health care providers and housewives were the occupations most frequently associated with hand eczema. Winter (33.6%) was the most common season which people experienced aggravation. The 63.0% and 67.0% answered that hand eczema hinders their personal relationship and negatively affects daily living activities, respectively. CONCLUSION: Hand eczema is a very common disease and hinders the quality of life. The appropriate identification of hand eczema is necessary to implement effective and efficient treatment.
Activities of Daily Living
;
Dermatitis, Contact
;
Eczema*
;
Female
;
Hand*
;
Health Personnel
;
Humans
;
Korea*
;
Medical Records
;
Occupations
;
Prevalence
;
Quality of Life
;
Seasons
;
Skin
;
Surveys and Questionnaires
10.Long-Term Clinical Outcomes of Korean Patient With Crohn's Disease Following Early Use of Infliximab.
Nam Hee KIM ; Yoon Suk JUNG ; Chang Mo MOON ; Shin Yeong LEE ; Eun Ran KIM ; Young Ho KIM ; Chang Kyun LEE ; Suck Ho LEE ; Jae Hak KIM ; Kyu Chan HUH ; Soon Man YOON ; Hyun Joo SONG ; Sun Jin BOO ; Hyun Joo JANG ; You Sun KIM ; Kang Moon LEE ; Jeong Eun SHIN ; Dong Il PARK
Intestinal Research 2014;12(4):281-286
BACKGROUND/AIMS: Several recent studies have reported that the early use of infliximab (IFX) improves the prognosis of Crohn's disease (CD). However, no data are available from Asian populations, as the forementioned studies have all been conducted in Western countries. The aim of the current study was to evaluate the impact of early use of IFX on the prognosis of Korean patients with CD. METHODS: Patients with a diagnosis of CD established between July 1987 and January 2012 were investigated in 12 university hospitals in Korea. Because insurance coverage for IFX treatment began in August 2005, patients were assigned to either of 2 groups based on diagnosis date. The first group included patients diagnosed from July 1987 to December 2005, and the second from January 2006 to January 2012. We compared the cumulative probabilities of operation and reoperation between the two groups using the Kaplan-Meier method and a log-rank test. RESULTS: Of the 721 patients investigated, 443 (61.4%) comprized the second group. Although the cumulative probabilities of immunosuppressant (P<0.001) and IFX use (P<0.001) after diagnosis were significantly higher in the second group, there were no significant differences in cumulative probabilities of operation (P=0.905) or reoperation (P=0.418) between two groups. CONCLUSIONS: The early use of IFX did not reduce CD-related surgery requirements in Korean patients with CD. These study results suggest that the early use of IFX may have little impact on the clinical outcome of CD in Korean patients in the setting of a conventional step-up algorithm.
Asian Continental Ancestry Group
;
Crohn Disease*
;
Diagnosis
;
Hospitals, University
;
Humans
;
Infliximab
;
Insurance Coverage
;
Korea
;
Prognosis
;
Reoperation

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