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Borbély Y, Kroell D, Gerber S, Fringeli Y, Linas I, Zehetner J. A safety and effectiveness evaluation of refluxstop in the treatment of acid reflux comparing large and small hiatal hernia groups: results from 99 patients in Switzerland with up to 4-years follow-up. Hernia 2025; 29:156. [PMID: 40317294 PMCID: PMC12049369 DOI: 10.1007/s10029-025-03339-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/28/2024] [Accepted: 04/06/2025] [Indexed: 05/07/2025]
Abstract
BACKGROUND Standard-of-care surgical treatments for gastroesophageal reflux disease (GERD), with large hiatal hernia (HH), result in a reoperation rate of up to 50% at 5 years. RefluxStop, acting as a mechanical stop without encircling the food passageway, offers a novel approach to treat large HH patients. This study assesses the safety and efficacy of RefluxStop surgery comparing large and small HH groups followed for up to 4 years. METHODS Two cohorts were retrospectively analyzed in a combined investigator-initiated study evaluating safety outcomes of RefluxStop in severe GERD subjects, comparing concomitant small (≤3 cm) and large HH (4-10 cm) in Switzerland. Primary outcomes were procedure-related adverse events (AEs/ADEs). The secondary outcome was improvement in GERD-HRQL score. RESULTS Ninety-nine subjects underwent the RefluxStop surgical procedure, whereof 50 subjects had small (≤3 cm) and 49 subjects had large HH (4-10 cm). One surgeon at each site operated on both small and large hernia patients. No significant difference in AEs between patients with small and large HH was shown. At 1-year follow-up, subjects in both groups experienced statistically significant improvements in median (IQR) GERD-HRQL score of 93.8% (81.8%; 98.7%) for those with large HH and 85.7% (76.5%; 92.3%) for those with small HH. CONCLUSION RefluxStop surgery for GERD effectively treats patients with large HH that currently have no optimal treatment options, while showing significantly improved results for up to 4 years. Furthermore, RefluxStop provides equally favorable results and a robust low risk profile for subjects with either concomitant small (n = 49) and large (n = 50) HH.
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Affiliation(s)
- Yves Borbély
- Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, Bern, Switzerland.
| | - Dino Kroell
- Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, Bern, Switzerland
| | - Sarah Gerber
- Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, Bern, Switzerland
| | - Yannick Fringeli
- Department of Visceral Surgery, Hirslanden Clinic Beau-Site, Bern, Switzerland
| | - Ioannis Linas
- Department of Gastroenterology, Hirslanden Clinic Beau-Site, Bern, Switzerland
| | - Joerg Zehetner
- Department of Visceral Surgery, Hirslanden Clinic Beau-Site, Bern, Switzerland
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Kang N, Kang MG, Lee SE, Kang SY, Jo EJ, Lee JH, Kim SH, Bahn JW, Lee BJ, Song WJ. Efficacy and Safety of Fexuprazan Versus Esomeprazole for Gastroesophageal Reflux Disease-Related Chronic Cough: A Randomized, Double-Blind, Active-Controlled Exploratory Trial. Lung 2025; 203:59. [PMID: 40299084 PMCID: PMC12041137 DOI: 10.1007/s00408-025-00815-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/03/2025] [Accepted: 04/19/2025] [Indexed: 04/30/2025]
Abstract
PURPOSE Potassium-competitive acid blockers (P-CABs) are a newer class of acid suppressants with convenient dosing and a rapid onset of action, while showing efficacy comparable to proton pump inhibitors (PPIs) in treating peptic symptoms of gastroesophageal reflux disease (GERD). This study aimed to assess the effect of P-CABs on GERD-related chronic cough. METHODS This randomized, double-blind, active-controlled, exploratory trial evaluated adults with chronic cough (≥ 8 weeks) and a recent physician diagnosis of GERD or peptic symptoms (< 1 month). Participants were randomized (1:1) to receive either fexuprazan 40 mg or esomeprazole 40 mg (PPI) once daily for eight weeks, along with matched placebos. The primary endpoint was the change in Leicester Cough Questionnaire (LCQ) score from baseline. Secondary endpoints included changes in the cough severity Numerical Rating Scale (NRS) and Reflux Disease Questionnaire (RDQ) scores. Safety was evaluated through monitoring adverse events. RESULTS Of the 190 subjects recruited, 161 met the selection criteria and were randomized, and 146 completed the trial. The participants were predominantly female (74.3%, mean age 39 ± 12 years). After 8 weeks of treatment, cough-related quality of life improved significantly, with comparable LCQ scores change between the groups (fexuprazan: 4.9 ± 4.0 vs. esomeprazole: 5.3 ± 3.8, p = 0.558). Changes in cough severity NRS and RDQ scores were also similar between the groups. Adverse events were comparable and consisted mostly of mild symptoms. CONCLUSION These findings support the potential of P-CABs as a promising alternative to PPIs for patients with chronic cough requiring acid-suppressive therapy.
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Affiliation(s)
- Noeul Kang
- Division of Allergy, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Min-Gyu Kang
- Departmemt of Internal Medicine, Chungbuk National University Hospital, Chungbuk National College of Medicine, Cheongju, Korea
| | - Seung Eun Lee
- Department of Internal Medicine, School of Medicine, Pusan National University, Pusan National University Yangsan Hospital, Yangsan, Korea
| | - Sung-Yoon Kang
- Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea
| | - Eun-Jung Jo
- Department of Internal Medicine, Pusan National University College of Medicine, Busan, Korea
| | - Ji Ho Lee
- Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea
| | - Sae-Hoon Kim
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
| | - Joon-Woo Bahn
- Department of Convergence Medicine, Asan Medical Center, Seoul, Korea
| | - Byung-Jae Lee
- Division of Allergy, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Woo-Jung Song
- Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea.
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Al-Frejat Z, Martini N, Esper A, Al-Frejat D, Younes S, Hanna M. GERD: Latest update on acid-suppressant drugs. CURRENT RESEARCH IN PHARMACOLOGY AND DRUG DISCOVERY 2024; 7:100198. [PMID: 39282236 PMCID: PMC11393603 DOI: 10.1016/j.crphar.2024.100198] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2024] [Revised: 08/07/2024] [Accepted: 08/19/2024] [Indexed: 09/18/2024] Open
Abstract
GERD is a very familiar diagnosis among health care providers due to its massive spread, and its symptoms can affect the quality of life for a respectable slice of its patients. Therefore, what can only be described as a logical consequence, a pursuit of a treatment that can both relieve symptoms and have minimal side effects is still ongoing to cover the large demographic affected by GERD. In the following review, analysis will be made of GERD, including possible regulatory activity, of certain drugs to the already discussed pathways involved in GERD patients.
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Affiliation(s)
- Zyad Al-Frejat
- Faculty of Medicine, Al Baath University, Homs, Syria
- Faculty of Medicine, Damascus University, Damascus, Syria
| | - Nafiza Martini
- Faculty of Medicine, Damascus University, Damascus, Syria
- Stemosis for Scientific Research, Damascus, Syria
| | - Alia Esper
- Faculty of Medicine, Al Baath University, Homs, Syria
- Stemosis for Scientific Research, Damascus, Syria
| | - Diana Al-Frejat
- Faculty of Medicine, Damascus University, Damascus, Syria
- Faculty of Dentistry, Syrian Private University, Damascus, Syria
| | - Samer Younes
- Faculty of Pharmacy, Tartous University, Tartous, Syria
- Stemosis for Scientific Research, Damascus, Syria
| | - Majd Hanna
- Faculty of Medicine, Damascus University, Damascus, Syria
- Stemosis for Scientific Research, Damascus, Syria
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Zhang N, Han M, Zheng QW, Zhang MY, Zhi WL, Li JJ, Cui LX, Tian JL, Wang Y, Fang SQ. A scientometrics analysis and visualization of refractory gastroesophageal reflux disease. Front Pharmacol 2024; 15:1393526. [PMID: 39139634 PMCID: PMC11319146 DOI: 10.3389/fphar.2024.1393526] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/29/2024] [Accepted: 07/18/2024] [Indexed: 08/15/2024] Open
Abstract
Background Refractory gastroesophageal reflux disease (refractory GERD) is a heterogeneous disease characterized by unresponsiveness or poor efficacy to proton-pump inhibitors (PPIs). This chronic disorder substantially weakens patients' mental wellbeing and quality of life, increasing the financial burden on society. Multiple articles have been reported in this area. However, literature involving scientometric analysis of refractory GERD is absent. Therefore, it is necessary to understand the evolution of research themes and the main hotspots of refractory GERD through bibliometric methods. Methods All documents related to refractory GERD based on the WOS Core Collection from January 2000 to November 2023 were selected for analysis. Citespace V 6.1 R6, VOSviewer V 1.6.20, and Scimago Graphica V 1.0.38 were used to perform bibliometric analysis. Results We collected a total of 241 research articles from 36 countries and 322 institutions, contributed by over 1,000 authors. Over the last 20 years, the number of articles in this field has increased year by year, and since 2011, the number of publications has increased dramatically, with 85.89% of the papers. These countries are led by the United States and Japan. GUT had the highest number of citations and DIGESTION had the highest number of publications. Research on standardized diagnosis and management, mechanisms, novel monitoring methods, and innovative drugs and procedures for refractory GERD are the main topics and hotspots in this field. This study also found that neuroimmune interaction is closely related to refractory GERD, which may be a new direction for future mechanism research. Conclusion Our study is the first bibliometric analysis of the global literature on refractory GERD. This research provides valuable insights for researchers, enabling them to quickly understand the research frontier and hot topics of this field.
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Affiliation(s)
| | | | | | | | | | | | | | | | | | - Sheng-Quan Fang
- Department of Gastroenterology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
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Jeong Y, Lee BJ, Han SH. RETRACTED: A Phase III Head-to-Head Study to Compare the Efficacy and Safety of Fexuprazan and Esomeprazole in Treating Patients with Erosive Esophagitis. J Clin Med 2024; 13:3262. [PMID: 38892973 PMCID: PMC11172701 DOI: 10.3390/jcm13113262] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/16/2024] [Revised: 05/19/2024] [Accepted: 05/22/2024] [Indexed: 06/21/2024] Open
Abstract
Background: Fexuprazan (Fexuclue®; Daewoong Pharmaceutical Co., Ltd., Seoul, Korea) is a novel potassium-competitive acid blocker (P-CAB). This multi-center, randomized, double-blind, active-controlled, parallel-group, therapeutic confirmatory, phase III study was conducted to assess its efficacy and safety compared with esomeprazole (Nexium®; AstraZeneca, Gothenburg, Mölndal, Sweden) in Korean patients with erosive esophagitis (EE). Methods: This study evaluated patients diagnosed with EE at a total of 25 institutions in Korea between 13 December 2018 and 7 August 2019. After voluntarily submitting a written informed consent form, the patients were evaluated using a screening test and then randomized to either of the two treatment arms. The proportion of the patients who achieved the complete recovery of mucosal breaks at 4 and 8 weeks, the proportion of those who achieved the complete recovery of heartburn at 3 and 7 days and 8 weeks, and changes in the GERD-Health-Related Quality of Life Questionnaire (GERD-HRQL) scores at 4 and 8 weeks from baseline served as efficacy outcome measures. The incidence of treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) and the serum gastrin levels served as safety outcome measures. Results: The study population comprised a total of 231 patients (n = 231) with EE, including 152 men (65.80%) and 79 women (34.20%); their mean age was 54.37 ± 12.66 years old. There were no significant differences in the efficacy and safety outcome measures between the two treatment arms (p > 0.05). Conclusions: It can be concluded that the efficacy and safety of Fexuclue® are not inferior to those of esomeprazole in Korean patients with EE.
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Affiliation(s)
- Yuchul Jeong
- Department of Internal Medicine, Chungna Good Hospital, Incheon 22738, Republic of Korea
| | - Beom Jun Lee
- St. Mary’s Best ENT Clinic, Seoul 08849, Republic of Korea
| | - Se-Hyeon Han
- Department of Companion Animal Industry, College of Health Science, Honam University, Gwangju 62399, Republic of Korea
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Zhuang Q, Liao A, He Q, Liu C, Zheng C, Li X, Liu Y, Wang B, Liu S, Zhang Y, Lin R, Chen H, Deng M, Tang Y, He C, Dai W, Tang H, Gong L, Li L, Xu B, Yang C, Zhou B, Su D, Guo Q, Li B, Zhou Y, Wang X, Fei S, Wu H, Wei S, Peng Z, Wang J, Li Y, Wang H, Deng T, Ding S, Li F, Chen M, Xiao Y. The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study. J Gastroenterol Hepatol 2024; 39:658-666. [PMID: 38251791 DOI: 10.1111/jgh.16471] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/30/2023] [Revised: 11/22/2023] [Accepted: 12/18/2023] [Indexed: 01/23/2024]
Abstract
BACKGROUND AND AIM Fexuprazan is a novel potassium-competitive acid blocker (P-CAB). This study aimed to explore the noninferior efficacy and safety of fexuprazan to esomeprazole in treating erosive esophagitis (EE). METHODS This was a phase III, randomized, double-blind multicenter study. Patients with endoscopically confirmed EE were randomized to receive fexuprazan 40 mg or esomeprazole 40 mg once a daily for 4-8 weeks. The healing rates of EE, symptom response, GERD-health-related quality life (GERD-HRQL), and treatment-emergent adverse events (TEAEs) were compared between fexuprazan group and esomeprazole group. RESULTS A total of 332 subjects were included in full analysis set (FAS) and 311 in per-protocol set (PPS). The healing rates of fexuprazan and esomeprazole groups at 8 weeks were 88.5% (146/165) and 89.0% (145/163), respectively, in FAS and 97.3% (145/149) and 97.9% (143/146), respectively, in PPS. Noninferiority of fexuprazan compared with esomeprazole according to EE healing rates at 8 weeks was demonstrated in both FAS and PPS analysis. No significant difference was found between groups in EE healing rates at 4 weeks, symptom responses, and changes of GERD-HRQL. The incidence of drug-related AEs was 19.4% (32/165) in fexuprazan arm and 19.6% (32/163) in esomeprazole arm. CONCLUSION This study demonstrated noninferior efficacy of fexuprazan to esomeprazole in treating EE. The incidence of TEAEs was similar between fexuprazan and esomeprazole. Trial registration number NCT05813561.
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Affiliation(s)
- Qianjun Zhuang
- Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
| | - Aijun Liao
- Department of Gastroenterology, The First Affiliated Hospital of University of South China, Hengyang, Hunan, China
| | - Qingling He
- Department of Gastroenterology, The Second People's Hospital of Yibin, Yibin, Sichuan, China
| | - Chengxia Liu
- Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou, Shandong, China
| | - Changqing Zheng
- Department of Gastroenterology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
| | - Xing Li
- Department of Gastroenterology, Pingxiang People's Hospital, Pingxiang, Jiangxi, China
| | - Youli Liu
- Department of Gastroenterology, Xuancheng People's Hospital, Xuancheng, Anhui, China
| | - Bangmao Wang
- Department of Gastroenterology, Tianjin Medical University General Hospital, Tianjin, China
| | - Side Liu
- Department of Gastroenterology, Nanfang Hospital, Guangzhou, Guangdong, China
| | - Yan Zhang
- Department of Gastroenterology, Zigong Fourth People's Hospital, Zigong, Sichuan, China
| | - Rong Lin
- Department of Gastroenterology, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Huixin Chen
- Department of Gastroenterology, Huizhou Municipal Central Hospital, Huizhou, Guangdong, China
| | - Min Deng
- Department of Gastroenterology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
| | - Yanping Tang
- Department of Gastroenterology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China
| | - Chiyi He
- Department of Gastroenterology, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Weijie Dai
- Department of Gastroenterology, Huai'an First People's Hospital, Huai'an, Jiangsu, China
| | - Haitao Tang
- Department of Gastroenterology, Lu'an People's Hospital, Lu'an, Anhui, China
| | - Lei Gong
- Department of Gastroenterology, Wuxi Second People's Hospital, Wuxi, Jiangsu, China
| | - Liangping Li
- Department of Gastroenterology, Sichuan Province People's Hospital, Chengdu, Sichuan, China
| | - Baohong Xu
- Department of Gastroenterology, Beijing Luhe Hospital Capital Medical University, Beijing, China
| | - Changqing Yang
- Department of Gastroenterology, Tongji Hospital of Tongji University, Shanghai, China
| | - Bingxi Zhou
- Department of Gastroenterology, Henan Provincial People's Hospital, Zhengzhou, Henan, China
| | - Dongxing Su
- Department of Gastroenterology, The Second Nanning People's Hospital, Nanning, Guangxi, China
| | - Qinghong Guo
- Department of Gastroenterology, The First Hospital of Lanzhou University, Lanzhou, Gansu, China
| | - Bin Li
- Department of Gastroenterology, Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, China
| | - Yongjian Zhou
- Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou, Guangdong, China
| | - Xiaoyang Wang
- Department of Gastroenterology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
| | - Sujuan Fei
- Department of Gastroenterology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
| | - Huili Wu
- Department of Gastroenterology, Zhengzhou Central Hospital, Zhengzhou, Henan, China
| | - Sichen Wei
- Department of Gastroenterology, Cangzhou Central Hospital, Cangzhou, Hebei, China
| | - Zhihong Peng
- Department of Gastroenterology, The Southwest Hospital of Army Medical University, Chongqing, China
| | - Jianning Wang
- Department of Gastroenterology, Nanjing Jiangning Hospital, Nanjing, Jiangsu, China
| | - Yanqing Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Hong Wang
- Department of Gastroenterology, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China
| | - Tianwei Deng
- Department of Gastroenterology, Chongqing University Three Gorges Hospital, Chongqing, China
| | - Shigang Ding
- Department of Gastroenterology, Peking University Third Hospital, Beijing, China
| | - Fangfang Li
- Department of Gastroenterology, Chenzhou First People's Hospital, Chenzhou, Hunan, China
| | - Minhu Chen
- Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
| | - Yinglian Xiao
- Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
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Najah H, Edelmuth RCL, Riascos MC, Grier A, Al Asadi H, Greenberg JA, Miranda I, Crawford CV, Finnerty BM, Fahey TJ, Zarnegar R. Long-term potassium-competitive acid blockers administration causes microbiota changes in rats. Surg Endosc 2023; 37:7980-7990. [PMID: 37452210 DOI: 10.1007/s00464-023-10269-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/30/2023] [Accepted: 06/29/2023] [Indexed: 07/18/2023]
Abstract
BACKGROUND Vonoprazan is a new potassium-competitive acid blocker (P-CAB) that was recently approved by the FDA. It is associated with a fast onset of action and a longer acid inhibition time. Vonoprazan-containing therapy for helicobacter pylori eradication is highly effective and several studies have demonstrated that a vonoprazan-antibiotic regimen affects gut microbiota. However, the impact of vonoprazan alone on gut microbiota is still unclear.Please check and confirm the authors (Maria Cristina Riascos, Hala Al Asadi) given name and family name are correct. Also, kindly confirm the details in the metadata are correct.Yes they are correct. METHODS: We conducted a prospective randomized 12-week experimental trial with 18 Wistar rats. Rats were randomly assigned to one of 3 groups: (1) drinking water as negative control group, (2) oral vonoprazan (4 mg/kg) for 12 weeks, and (3) oral vonoprazan (4 mg/kg) for 4 weeks, followed by 8 weeks off vonoprazan. To investigate gut microbiota, we carried out a metagenomic shotgun sequencing of fecal samples at week 0 and week 12.Please confirm the inserted city and country name is correct for affiliation 2.Yes it's correct. RESULTS For alpha diversity metrics at week 12, both long and short vonoprazan groups had lower Pielou's evenness index than the control group (p = 0.019); however, observed operational taxonomic units (p = 0.332) and Shannon's diversity index (p = 0.070) were not statistically different between groups. Beta diversity was significantly different in the three groups, using Bray-Curtis (p = 0.003) and Jaccard distances (p = 0.002). At week 12, differences in relative abundance were observed at all levels. At phylum level, short vonoprazan group had less of Actinobacteria (log fold change = - 1.88, adjusted p-value = 0.048) and Verrucomicrobia (lfc = - 1.76, p = 0.009).Please check and confirm that the author (Ileana Miranda) and their respective affiliation 3 details have been correctly identified and amend if necessary.Yes it's correct. At the genus level, long vonoprazan group had more Bacteroidales (lfc = 5.01, p = 0.021) and Prevotella (lfc = 7.79, p = 0.001). At family level, long vonoprazan group had more Lactobacillaceae (lfc = 0.97, p = 0.001), Prevotellaceae (lfc = 8.01, p < 0.001), and less Erysipelotrichaceae (lfc = - 2.9, p = 0.029). CONCLUSION This study provides evidence that vonoprazan impacts the gut microbiota and permits a precise delineation of the composition and relative abundance of the bacteria at all different taxonomic levels.
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Affiliation(s)
- Haythem Najah
- Division of Endocrine & Minimally Invasive Surgery, Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medical College, 525 East 68th Street, K-836, New York, NY, 10065, USA.
| | - Rodrigo C L Edelmuth
- Division of Endocrine & Minimally Invasive Surgery, Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medical College, 525 East 68th Street, K-836, New York, NY, 10065, USA
- Hospital Israelita Albert Einstein, São Paulo, Brazil
| | - Maria Cristina Riascos
- Division of Endocrine & Minimally Invasive Surgery, Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medical College, 525 East 68th Street, K-836, New York, NY, 10065, USA
| | - Alex Grier
- Microbiome Core Lab of Weill Cornell Medicine, New York, NY, USA
| | - Hala Al Asadi
- Division of Endocrine & Minimally Invasive Surgery, Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medical College, 525 East 68th Street, K-836, New York, NY, 10065, USA
| | - Jacques A Greenberg
- Division of Endocrine & Minimally Invasive Surgery, Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medical College, 525 East 68th Street, K-836, New York, NY, 10065, USA
| | - Ileana Miranda
- Laboratory of Comparative Pathology (LCP), Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, The Rockefeller University, New York, NY, USA
| | - Carl V Crawford
- Division of Gastroenterology and Hepatology, Department of Medicine, New York-Presbyterian Hospital, Weill Cornell Medical College, New York, NY, USA
| | - Brendan M Finnerty
- Division of Endocrine & Minimally Invasive Surgery, Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medical College, 525 East 68th Street, K-836, New York, NY, 10065, USA
| | - Thomas J Fahey
- Division of Endocrine & Minimally Invasive Surgery, Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medical College, 525 East 68th Street, K-836, New York, NY, 10065, USA
| | - Rasa Zarnegar
- Division of Endocrine & Minimally Invasive Surgery, Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medical College, 525 East 68th Street, K-836, New York, NY, 10065, USA
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Begg M, Tarhuni M, N Fotso M, Gonzalez NA, Sanivarapu RR, Osman U, Latha Kumar A, Sadagopan A, Mahmoud A, Khan S. Comparing the Safety and Efficacy of Proton Pump Inhibitors and Histamine-2 Receptor Antagonists in the Management of Patients With Peptic Ulcer Disease: A Systematic Review. Cureus 2023; 15:e44341. [PMID: 37779765 PMCID: PMC10538946 DOI: 10.7759/cureus.44341] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/15/2023] [Accepted: 08/29/2023] [Indexed: 10/03/2023] Open
Abstract
Peptic ulcer disease (PUD) refers to the occurrence of an open erosion in the inner lining of the stomach, duodenum, or sometimes lower esophagus. Treatments like proton pump inhibitors (PPIs) or histamine 2 receptor antagonists (H2RAs) are available on the market to efficiently treat the break in the mucosal lining. However, there is little evidence about the effects of the medication on the type and location of the ulcer and the epigastric pain caused by disintegration and increased acidity in the stomach. Given the above, we conducted a systematic review comparing the safety and efficacy of PPIs and H2RAs in various ulcer locations (gastric, duodenal, and pre-pyloric) and the effect of prolonging the treatment with the same medication or changing into a drug from another class in treatment-resistant ulcers. We employed major research literature databases and search engines such as PubMed, Medical Literature Analysis and Retrieval System Online (MEDLINE), Science Direct, and Google Scholar to find relevant articles. After a thorough screening, a quality check using various tools, and applying filters that suited our eligibility criteria, we identified eight articles, of which five were random clinical trials (RCTs), two review articles, and one meta-analysis. This study compares the different side effects of PPIs and H2RAs. Most studies concluded that omeprazole is superior in healing ulcers and bringing pain relief and that patients resistant to H2RAs can be treated better when switched to a PPI. This study also discusses the adverse effects of chronic use, such as diarrhea, constipation, headaches, and gastrointestinal infections. Patients on long-term PPI therapy are required to take calcium supplements to prevent the risk of fractures in older adults. Regarding long-term outcomes, PPIs remain the mainstay of treatment for peptic ulcer disease, based on the papers we reviewed.
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Affiliation(s)
- Maha Begg
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Mawada Tarhuni
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfiled, USA
| | - Monique N Fotso
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Natalie A Gonzalez
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Raghavendra R Sanivarapu
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfiled, USA
| | - Usama Osman
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Abishek Latha Kumar
- Internal Medicine, Pediatrics, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Aishwarya Sadagopan
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Anas Mahmoud
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfiled, USA
| | - Safeera Khan
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
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9
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Kim M, Kim B, Lee JH, Kim D, Song GS, Williams SD, Son WC. Carcinogenicity assessment of tegoprazan in Sprague-Dawley (Crl:CD) rats and ICR (Crl:CD1) mice. Regul Toxicol Pharmacol 2023:105424. [PMID: 37295487 DOI: 10.1016/j.yrtph.2023.105424] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/01/2023] [Revised: 04/22/2023] [Accepted: 06/02/2023] [Indexed: 06/12/2023]
Abstract
Tegoprazan is a novel potassium-competitive acid blocker (P-CAB) that reversibly inhibits the proton pump in gastric parietal cells and has been approved for the treatment of acid-related diseases in Korea. This study aimed to evaluate the carcinogenic potential of tegoprazan in Sprague-Dawley rats and CD-1 mice. Tegoprazan was administered daily by oral gavage to rats for up to 94 weeks and mice for up to 104 weeks. Evidence of carcinogenic potential of tegoprazan was identified in rats only and was limited to benign and/or malignant neuroendocrine cell tumors at exposures >7-fold of the recommended human dose. Glandular stomach findings were considered secondary to the expected pharmacology of tegoprazan, characterized by their location in the fundic and body regions of the stomach. Overall, tegoprazan induced gastric enterochromaffin-like (ECL) cell tumors in SD rats, but did not produce any treatment-related statistically significant increase in the incidence of neoplasms relevant to humans when administered to SD rats and CD-1 mice by gavage at doses up to 300 and 150 mg/kg/day, respectively. Gastric ECL cell tumors are thought to be induced by the exaggerated indirect pharmacological effect of tegoprazan, similar to that reported for proton pump inhibitors (PPIs) and other P-CABs.
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Affiliation(s)
- Myeongjoong Kim
- Department of Medical Science, Asan Medical Institute of Convergence Science and Technology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea; HK inno.N Corporation, Seoul, South Korea
| | | | | | | | | | | | - Woo-Chan Son
- Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
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10
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Ku JM, Cho JH, Kim K, Kim JY, Kim JY, Kim J, Cha H, Cheon B. JP-1366: A novel and potent potassium-competitive acid blocker that is effective in the treatment of acid-related diseases. Pharmacol Res Perspect 2023; 11:e01090. [PMID: 37147903 PMCID: PMC10163344 DOI: 10.1002/prp2.1090] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2023] [Revised: 04/06/2023] [Accepted: 04/10/2023] [Indexed: 05/07/2023] Open
Abstract
The global prevalence of GERD is substantially increasing each year, and GERD is a chronic disease that reduces the quality of life of patients. The efficacy of conventional drugs is diverse, and most require long-term or lifetime administration; thus, the development of more effective therapeutic agents is needed. Herein, a more effective treatment for GERD was tested. We investigated whether JP-1366 affected gastric H+/K+-ATPase activity and used the Na+/K+-ATPase assay to confirm the selectivity of H+/K+-ATPase inhibition. To clarify the mechanism of enzyme inhibition, JP-1366 and TAK-438 were analyzed by Lineweaver-Burk. Also, we investigated the effects of JP-1366 in various models involving reflux esophagitis. We found that JP-1366 mediates strong, selective, and dose-dependent inhibition of H+/K+-ATPase. We found that JP-1366 significantly suppressed gastric acid secretion in histamine-treated pylorus-ligated rats in a dose-dependent manner. Additionally, we confirmed that JP-1366 inhibited histamine-stimulated gastric acid secretion in the HPD model. JP-1366 exhibited a more than 2-fold higher inhibitory effect on esophageal injury than TAK-438 in GERD lesions and had a more potent inhibitory effect in indomethacin- or aspirin-induced gastric ulcer rat models than TAK-438. Additionally, JP-1366 inhibited gastric ulcers. These results support the possibility that JP-1366 is a good candidate drug for treating acid-related diseases.
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Affiliation(s)
- Jin Mo Ku
- Pharmacological Toxicology Laboratory, Jeil Pharmaceutical, Yongin-si, South Korea
| | - Jin Hee Cho
- Pharmacological Toxicology Laboratory, Jeil Pharmaceutical, Yongin-si, South Korea
| | - Kangjeon Kim
- Pharmacological Toxicology Laboratory, Jeil Pharmaceutical, Yongin-si, South Korea
| | - Ji Yoon Kim
- Division of New Drug Development, Jeil Pharmaceutical, Yongin-si, South Korea
| | - Jong Yup Kim
- Division of New Drug Development, Jeil Pharmaceutical, Yongin-si, South Korea
| | - John Kim
- Onconic Therapeutics Inc, Seoul, South Korea
| | - Hyunju Cha
- Onconic Therapeutics Inc, Seoul, South Korea
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11
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Guo K, He X, Zhao H, Ma C. Characterisation of degradation products of tegoprazan by LC-MS and GC-MS. J Pharm Biomed Anal 2023; 228:115323. [PMID: 36921447 DOI: 10.1016/j.jpba.2023.115323] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2023] [Revised: 03/01/2023] [Accepted: 03/02/2023] [Indexed: 03/06/2023]
Abstract
Tegoprazan is a novel orally active potassium-competitive acid blocker (P-CAB), capable of binding to the K+ binding site of H+/K+-ATPase in a reversible way to inhibit gastric acid secretion. Tegoprazan has been approved for treating acid-related diseases. In this study, stress testings of tegoprazan were performed under various conditions, including hydrolysis (acidic, alkaline, and neutral), oxidation, photolysis, and thermal stress. Tegoprazan showed instability in acidic, alkaline, and oxidative conditions. Eight degradation products (DPs) were identified. The DPs were characterized by LC-HRMS, LC-MSn, or GC-Q-TOF-MS. Meanwhile, DP-1, DP-2 and DP-3 were successfully synthesized and confirmed by NMR. The degradation pathway of tegoprazan was summarized. To the best of our knowledge, this is the first study on the forced degradation of tegoprazan.
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Affiliation(s)
- Kaijing Guo
- Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China
| | - Xiao He
- Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China
| | - Hongyi Zhao
- Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China
| | - Chen Ma
- Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China.
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12
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Choi YJ. [Treatment of Acid-related Diseases Using Potassium-competitive Acid Blockers]. THE KOREAN JOURNAL OF GASTROENTEROLOGY = TAEHAN SOHWAGI HAKHOE CHI 2022; 80:247-253. [PMID: 36567437 DOI: 10.4166/kjg.2022.143] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/06/2022] [Revised: 12/16/2022] [Accepted: 12/17/2022] [Indexed: 12/27/2022]
Abstract
Proton pump inhibitors (PPIs) have several limitations to their efficacy including insufficient acid suppression, slow onset of action, and variable efficacy among patients due to CYP2C19 metabolism. Potassium-competitive acid blockers inhibit H+-K+-ATPase in a reversible and K+-competitive manner, are novel acid suppressive drugs with rapid onset of action, meal independence, and prolonged control of intragastric acidity compared to PPIs. Potassium-competitive acid blockers exhibited non-inferior therapeutic efficacies on reflux esophagitis, gastric ulcers, and Helicobacter pylori eradication. The review is focused on the unmet needs across the acid-related diseases and recent updates on clinical studies using vonoprazan and tegoprazan.
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Affiliation(s)
- Yoon Jin Choi
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
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13
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Zhu H, Pan X, Zhang L, Sun H, Fan H, Pan Z, Huang C, Shi Z, Ding J, Wang Q, Du Y, Lyu N, Li Z. Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study. Chin Med J (Engl) 2022; 135:2941-2949. [PMID: 36580650 PMCID: PMC10106214 DOI: 10.1097/cm9.0000000000002508] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/21/2022] [Indexed: 12/31/2022] Open
Abstract
BACKGROUND The pharmacokinetic and clinical behaviors of many proton pump inhibitors (PPIs) in peptic ulcer treatment are altered by CYP2C19 genetic polymorphisms. This non-inferiority study evaluated the efficacy and safety of the novel PPI anaprazole compared with rabeprazole. We also explored the influence of Helicobacter pylori ( H. pylori ) infection status and CYP2C19 polymorphism on anaprazole. METHODS In this multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled, phase III study, Chinese patients with duodenal ulcers were randomized 1:1 to receive rabeprazole 10 mg + anaprazole placebo or rabeprazole placebo + anaprazole 20 mg once daily for 4 weeks. The primary efficacy endpoint was the 4-week ulcer healing rate assessed by blinded independent review. Secondary endpoints were the proportion of patients with improved overall and individual duodenal ulcer symptoms at 4 weeks. Furthermore, exploratory subgroup analysis of the primary endpoint by H. pylori status and CYP2C19 polymorphism was conducted. Adverse events were monitored for safety. Non-inferiority analysis was conducted for the primary endpoint. RESULTS The study enrolled 448 patients (anaprazole, n = 225; rabeprazole, n = 223). The 4-week healing rates were 90.9% and 93.7% for anaprazole and rabeprazole, respectively (difference, -2.8% [95% confidence interval, -7.7%, 2.2%]), demonstrating non-inferiority of anaprazole to rabeprazole. Overall duodenal ulcer symptoms improved in 90.9% and 92.5% of patients, respectively. Improvement rates of individual symptoms were similar between the groups. Healing rates did not significantly differ by H. pylori status or CYP2C19 genotype for either treatment group. The incidence of treatment-emergent adverse events was similar for anaprazole (72/220, 32.7%) and rabeprazole (84/219, 38.4%). CONCLUSIONS The efficacy of anaprazole is non-inferior to that of rabeprazole in Chinese patients with duodenal ulcers. REGISTRATION ClinicalTrials.gov, NCT04215653.
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Affiliation(s)
- Huiyun Zhu
- Department of Gastroenterology, Changhai Hospital of Navy Military Medical University, Shanghai 200433, China
| | - Xue Pan
- Department of Gastroenterology, Changhai Hospital of Navy Military Medical University, Shanghai 200433, China
| | - Li Zhang
- Drug Clinical Trial Institution, Changhai Hospital of Navy Military Medical University, Shanghai 200433, China
| | - Hongxin Sun
- Department of Gastroenterology, Changhai Hospital of Navy Military Medical University, Shanghai 200433, China
| | - Huizhen Fan
- Department of Gastroenterology, Yichun People's Hospital, Yichun, Jiangxi 336028, China
| | - Zhongwei Pan
- Department of Gastroenterology, Meihekou Central Hospital, Meihekou, Jilin 135099, China
| | - Caibin Huang
- Department of Gastroenterology, The First Affiliated Hospital of Gannan Medical College, Ganzhou, Jiangxi 341001, China
| | - Zhenwang Shi
- Department of Gastroenterology, Hefei Second People's Hospital, Hefei, Anhui 230011, China
| | - Jin Ding
- Department of Gastroenterology, Jinhua Central Hospital, Jinhua, Zhejiang 321099, China
| | - Qi Wang
- Department of Gastroenterology, Anqing Municipal Hospital, Anqing, Anhui 246004, China
| | - Yiqi Du
- Department of Gastroenterology, Changhai Hospital of Navy Military Medical University, Shanghai 200433, China
| | - Nonghua Lyu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330006, China
| | - Zhaoshen Li
- Department of Gastroenterology, Changhai Hospital of Navy Military Medical University, Shanghai 200433, China
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14
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Lee KN, Lee OY, Chun HJ, Kim JI, Kim SK, Lee SW, Park KS, Lee KL, Choi SC, Jang JY, Kim GH, Sung IK, Park MI, Kwon JG, Kim N, Kim JJ, Lee ST, Kim HS, Kim KB, Lee YC, Choi MG, Lee JS, Jung HY, Lee KJ, Kim JH, Chung H. Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis. World J Gastroenterol 2022; 28:6294-6309. [PMID: 36504556 PMCID: PMC9730436 DOI: 10.3748/wjg.v28.i44.6294] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/04/2022] [Revised: 10/17/2022] [Accepted: 11/09/2022] [Indexed: 11/24/2022] Open
Abstract
BACKGROUND Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K+/H+-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan's suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner. AIM To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE). METHODS Korean adult patients with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg or esomeprazole 40 mg once daily for eight weeks. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy at week 8. The secondary endpoints included the healing rate of EE at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were compared between the groups. RESULTS Of the 263 randomized, 218 completed the study per protocol (fexuprazan 40 mg, n = 107; esomeprazole 40 mg, n = 111). Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8 [99.1% (106/107) vs 99.1% (110/111)]. There were no between-group differences in the EE healing rate at week 4 [90.3% (93/103) vs 88.5% (92/104)], symptom responses, and quality of life assessments. Additionally, serum gastrin levels at weeks 4 and 8 and drug-related side effects did not significantly differ between the groups. CONCLUSION Fexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8. We suggest that fexuprazan is an alternative promising treatment option to PPIs for patients with EE.
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Affiliation(s)
- Kang Nyeong Lee
- Department of Internal Medicine, Hanyang University College of Medicine, Seoul 04763, South Korea
| | - Oh Young Lee
- Department of Internal Medicine, Hanyang University College of Medicine, Seoul 04763, South Korea
| | - Hoon Jai Chun
- Department of Internal Medicine, Korea University Anam Hospital, Seoul 02841, South Korea
| | - Jin Il Kim
- Department of Internal Medicine, The Catholic University of Korea, Yeouido ST. Mary’s Hospital, Seoul 07260, South Korea
| | - Sung Kook Kim
- Department of Internal Medicine, Kyungpook National University Hospital, Daegu 41944, South Korea
| | - Sang Woo Lee
- Department of Internal Medicine, Korea University Ansan Hospital, Ansan-si 15355, South Korea
| | - Kyung Sik Park
- Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu 42601, South Korea
| | - Kook Lae Lee
- Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul 07061, South Korea
| | - Suck Chei Choi
- Department of Internal Medicine, Wonkwang University Hospital, Iksan 54538, South Korea
| | - Jae-Young Jang
- Department of Internal Medicine, KyungHee University Medical Center, Seoul 02447, South Korea
| | - Gwang Ha Kim
- Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan 47241, South Korea
| | - In-kyung Sung
- Department of Internal Medicine, KKonkuk University Medical Center, Seoul 05030, South Korea
| | - Moo In Park
- Department of Internal Medicine, Kosin University Gaspel Hospital, Busan 49267, South Korea
| | - Joong Goo Kwon
- Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu 42471, South Korea
| | - Nayoung Kim
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si 13620, Gyeonggi-do, South Korea
| | - Jae Jun Kim
- Department of Internal Medicine, Samsung Medical Center, Seoul 06351, South Korea
| | - Soo Teik Lee
- Department of Internal Medicine, Chonbuk National University Hospital, Jeonju-si 54907, South Korea
| | - Hyun Soo Kim
- Department of Internal Medicine, Chonnam National University Hospital, Gwangju 61469, South Korea
| | - Ki Bae Kim
- Department of Internal medicine, Chungbuk National University School of Medicine, Cheong Ju 28644, South Korea
| | - Yong Chan Lee
- Department of Internal Medicine, Severance Hospital, Seoul 03722, South Korea
| | - Myung-Gyu Choi
- Department of Internal Medicine, The Catholic University of Korea, Seoul ST. Mary’s Hospital, Seoul 06591, South Korea
| | - Joon Seong Lee
- Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul 04401, South Korea
| | - Hwoon-Yong Jung
- Department of Internal Medicine, Asan Medical Center, Seoul 05505, South Korea
| | - Kwang Jae Lee
- Department of Gastroenterology, Ajou University School of Medicine, Suwon 16499, South Korea
| | - Jie-Hyun Kim
- Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, South Korea
| | - Hyunsoo Chung
- Department of Internal Medicine, Seoul National University Hospital, Seoul 03080, South Korea
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15
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Xiao YL, Zhang MY, Tan ND, Chen SF, Zhuang QJ, Chen MH. Patient- and physician-reported satisfaction with gastroesophageal reflux disease (GERD) treatment in Chinese clinical practice. J Dig Dis 2022; 23:262-269. [PMID: 35734857 DOI: 10.1111/1751-2980.13104] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/21/2021] [Revised: 05/13/2022] [Accepted: 06/21/2022] [Indexed: 12/11/2022]
Abstract
OBJECTIVE The aim of this study was to assess the level of satisfaction with currently prescribed medications for gastroesophageal reflux disease (GERD) in patients and physicians in China. METHODS Physicians across China were invited to complete physician surveys concerning factors affecting the prescription of medication for GERD and their satisfaction through an online questionnaire. The enrolled physicians invited the first five GERD patients who visited them on the same day to complete online patient surveys concerning the satisfaction with medications for GERD and its influencing factors. RESULTS In total, 334 physician surveys (response rate 36.82%) and 1409 patient surveys (86.07%) were analyzed. Over half (62.57%) the physicians recommended taking a proton pump inhibitor (PPI) twice daily and the majority (88.02%) recommended taking a PPI for 1 week to 3 months. Factors affecting the prescription were how much it could improve quality of life (84.73%), followed by safety, medication compliance, and efficacy. Approximately 30% of patients reported taking a PPI twice daily and 47.20% reported taking a PPI for 1 week to 3 months. Factor affecting patients' adherence to medications was safety (64.30%), followed by medical insurance, efficacy and convenience. Approximately one-third of physicians and patients did not report "satisfied" or "very satisfied" with medications for GERD, including 10.51% of patients and 12.87% of physicians reporting "dissatisfied" or "very dissatisfied." CONCLUSION One-third of GERD patients and physicians were not satisfied or very satisfied with medications for GERD. Novel medications may help optimize the management of GERD.
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Affiliation(s)
- Ying Lian Xiao
- Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
| | - Meng Yu Zhang
- Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
| | - Nian Di Tan
- Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
| | - Song Feng Chen
- Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
| | - Qian Jun Zhuang
- Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
| | - Min Hu Chen
- Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China
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16
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Imparato RR, Toma TS. Proton pump inhibitor deprescription: A rapid review. BRAZ J PHARM SCI 2022. [DOI: 10.1590/s2175-97902022e19989] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
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17
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Xu WT, Xu XB, Ren TS, Qi XS. Vonoprazan for treatment of gastroesophageal reflux disease: Research advances. Shijie Huaren Xiaohua Zazhi 2021; 29:1248-1253. [DOI: 10.11569/wcjd.v29.i21.1248] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Affiliation(s)
- Wen-Tao Xu
- Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang 110840, Liaoning Province, China,Postgraduate College, Shenyang Pharmaceutical University, Shenyang 110016, Liaoning Province, China
| | - Xiang-Bo Xu
- Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang 110840, Liaoning Province, China,Postgraduate College, Shenyang Pharmaceutical University, Shenyang 110016, Liaoning Province, China
| | - Tian-Shu Ren
- Department of Pharmacy, General Hospital of Northern Theater Command, Shenyang 110840, Liaoning Province, China
| | - Xing-Shun Qi
- Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang 110840, Liaoning Province, China,Postgraduate College, Shenyang Pharmaceutical University, Shenyang 110016, Liaoning Province, China
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18
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Aleman R, Lo Menzo E, Szomstein S, Rosenthal RJ. De novo gastroesophageal reflux disease esophageal surgery in bariatrics: a literature review and analysis of the current treatment options. ANNALS OF TRANSLATIONAL MEDICINE 2021; 9:899. [PMID: 34164533 PMCID: PMC8184411 DOI: 10.21037/atm-20-5890] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 11/10/2022]
Abstract
With the exponential increase of worldwide obesity, the number of bariatric surgery (BaS) procedures have equally risen. The surgical management of obesity has been widely established as the standard of care for sustained weight reduction, resolution, and improvement of associated comorbidities. However, BaS itself can have postoperative deleterious effects, including de novo gastroesophageal reflux disease (GERD) and upper gastrointestinal motility disorders. The modified anatomy resulting from BaS, due to either a restrictive or hypoabsorptive component, gives this disorder a multifactorial etiology. The overall management of de novo GERD should focus on three primordial approaches: Non-surgical, endoluminal, and surgical. Even in the absence of de novo GERD following primary or secondary BaS, said disorder should be closely monitored and therapy should be catered in a case-by-case approach. Consequently, treatment strategies have been developed on this principle as to adequately resolve de novo GERD. Despite the presence of multiple and suitable treatment modalities, the operating surgeon should perform them in the best interest of the patient. Short-, medium-, and long-term outcomes should be taken into consideration prior to proceed with any type of preferred management option. This article herein presents an update on the surgical management of de novo GERD following BaS and current practical innovations.
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Affiliation(s)
- Rene Aleman
- Department of General Surgery and the Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, FL, USA
| | - Emanuele Lo Menzo
- Department of General Surgery and the Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, FL, USA
| | - Samuel Szomstein
- Department of General Surgery and the Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, FL, USA
| | - Raul J Rosenthal
- Department of General Surgery and the Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, FL, USA
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19
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Yoon DY, Sunwoo J, Shin N, Kim AR, Kim B, Song GS, Jang IJ, Lee S. Effect of meal timing on pharmacokinetics and pharmacodynamics of tegoprazan in healthy male volunteers. Clin Transl Sci 2021; 14:934-941. [PMID: 33382926 PMCID: PMC8212751 DOI: 10.1111/cts.12958] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2020] [Revised: 11/30/2020] [Accepted: 11/30/2020] [Indexed: 12/26/2022] Open
Abstract
Abstract Tegoprazan, a novel potassium‐competitive acid blocker, is used to treat acid‐related diseases. However, there is no information on the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of the marketed dosage of tegoprazan under various meal timings in a fed and fasted state. The study aimed to assess the effect of meal timing on PKs and PDs of tegoprazan 50 mg after a single administration in healthy male subjects. An open‐label, single‐dose, three‐treatment, three‐period crossover study was conducted. A total of 12 subjects were orally administered a single dose of tegoprazan 50 mg among various conditions: in a fasted state, at 30 min before or 30 min after a high‐fat meal. PK parameters were estimated by the noncompartmental method. Continuous 24‐h intragastric pH monitoring was done for PD analysis. The PKs and PDs of tegoprazan were compared among the various meal timings. Compared with the fasting condition, the PK profile of tegoprazan was similar when administered 30 min before a high‐fat meal; however, delayed absorption with similar systemic exposure was observed when administered 30 min after a high‐fat meal. The magnitude of acid suppression evaluated through the PD parameters increased when administered 30 min after a high‐fat meal compared with fasting the condition and when administered 30 min before a high‐fat meal. However, the increased difference in acid suppression was not clinically significant. Meal timing had no clinically significant effect on the PKs and PDs of tegoprazan 50 mg. Therefore, the marketed dosage of tegoprazan could be administered regardless of the meal timing.
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