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Keywords = erosive esophagitis

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12 pages, 1565 KiB  
Case Report
Severe Rectal Syphilis in the Setting of Profound HIV Immunosuppression: A Case Report Highlighting ERG/CD38 Immunophenotyping and a Review of the Literature
by Diana Marcela Carmona Valencia, Juan Diego López, Shirley Vanessa Correa Forero, Diana Marcela Bonilla Bonilla, Jorge Karim Assis and Yamil Liscano
Infect. Dis. Rep. 2025, 17(4), 85; https://doi.org/10.3390/idr17040085 - 16 Jul 2025
Viewed by 357
Abstract
Background and Aim: Syphilis, caused by Treponema pallidum, classically presents with genital or anal chancres; rectal involvement is rare and frequently misdiagnosed as inflammatory bowel disease or malignancy. We describe an unusually severe case of syphilitic proctitis in the setting of advanced [...] Read more.
Background and Aim: Syphilis, caused by Treponema pallidum, classically presents with genital or anal chancres; rectal involvement is rare and frequently misdiagnosed as inflammatory bowel disease or malignancy. We describe an unusually severe case of syphilitic proctitis in the setting of advanced HIV-related immunosuppression (CD4 39 cells/µL), in which targeted immunophenotyping (ERG and CD38) was a valuable adjunctive tool in the differential diagnosis. Case Presentation: A 46-year-old man with a recent history of erosive gastritis and esophageal candidiasis presented after six months of unintentional 20 kg weight loss, profound fatigue, intermittent fevers, profuse diarrhea, and two episodes of hematemesis. Workup revealed a new diagnosis of HIV infection (CD4: 39 cells/µL; viral load: 87,837 copies/mL). Contrast-enhanced CT demonstrated uniform, concentric rectal wall thickening (“target sign”). Colonoscopic biopsy showed exuberant granulation tissue and dense plasma cell infiltrates. Immunohistochemistry revealed a dense infiltrate of CD38-positive plasma cells and ERG-positive endothelial proliferation. These findings, in the context of positive serology, were highly supportive of a spirochetal etiology and helped differentiate it from potential mimics. Serology was positive for latent late syphilis (VDRL 1:64). The patient received three weekly doses of intramuscular benzathine penicillin; lumbar puncture excluded neurosyphilis. Discussion: This is among the first reported cases of syphilitic proctitis in a patient with CD4 < 50 cells/µL, where advanced immunophenotyping differentiated syphilitic inflammation from neoplastic or inflammatory mimics. Profound immunosuppression accelerates disease progression and yields atypical clinical features. Conclusion: In HIV-infected patients with chronic rectal symptoms, especially those with CD4 < 50 cells/µL, syphilitic proctitis must be considered. Integration of radiologic assessment, histopathology with ERG/CD38 staining, and serologic testing permits prompt diagnosis. Early benzathine penicillin therapy and rigorous clinical and serologic follow-up are essential to prevent complications, including neurosyphilis. Full article
(This article belongs to the Section Bacterial Diseases)
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14 pages, 1031 KiB  
Article
Remineralizing Treatments for Dental Erosion and Sensitivity in Patients Suffering from Gastroesophageal Reflux Disease (GERD): Randomized Clinical Trial
by Andrea Scribante, Alessia Pardo, Maurizio Pascadopoli, Federico Biagi, Annalisa Schiepatti, Valentina Giammona, Marco Vecchio, Christian Alquati, Gioia Giada Modica, Cinzia Casu and Andrea Butera
J. Clin. Med. 2025, 14(10), 3525; https://doi.org/10.3390/jcm14103525 - 18 May 2025
Viewed by 963
Abstract
Background: Gastroesophageal reflux disease (GERD) is a chronic condition that causes an abrupt decrease in salivary pH in the oral cavity, which can lead to demineralization, erosion, hypersensitivity, functional impairment, and possibly fracture of dental elements. The aim of this clinical study is [...] Read more.
Background: Gastroesophageal reflux disease (GERD) is a chronic condition that causes an abrupt decrease in salivary pH in the oral cavity, which can lead to demineralization, erosion, hypersensitivity, functional impairment, and possibly fracture of dental elements. The aim of this clinical study is to compare two types of treatment in patients with dental erosion diagnosed with gastroesophageal reflux. Methods: Thirty patients were enrolled in this randomized clinical trial. Each patient underwent clinical evaluation and esophageal pH measurement, in order to diagnose GERD. After an initial examination and assessment by an experienced dentist, the Trial group (15 patients) was assigned to home treatment with a zinc hydroxyapatite-based toothpaste and a hydroxyapatite-based paste, while the Control group (15 patients) was assigned to home treatment with zinc hydroxyapatite-based toothpaste only. The following indices were measured: Basic Erosive Wear Examination Index (BEWE); Schiff Air Index (SAI); Plaque Index (PI); and Bleeding Score (BS). Each index was assessed at T0 during the first visit, one month (T1), three months (T2), six months (T3), nine months (T4), and 12 months (T5). The Kolmogorov–Smirnov test was used to analyze the normality of the data, while Friedman’s test followed by Dunn’s post hoc test were used to compare the two groups (significance threshold: p < 0.05). Results: The results showed no statistically significant change in the BEWE and SAI indexes (p > 0.05). However, an improvement in dentin sensitivity and BS was observed. Plaque control also improved. Conclusions: The results of this study indicate that the additional hydroxyapatite paste did not significantly improve the outcomes of the study in respect to hydroxyapatite toothpaste alone. However, there was an improvement in the oral health of GERD patients using hydroxyapatite-based remineralizing treatment in terms of oral and periodontal indices calculated. Full article
(This article belongs to the Special Issue Interaction Between Systemic Diseases and Oral Diseases)
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31 pages, 1034 KiB  
Review
Updates in Gastroesophageal Reflux Disease Management: From Proton Pump Inhibitors to Dietary and Lifestyle Modifications
by Jakov Ivan Bucan, Tamara Braut, Antea Krsek, Vlatka Sotosek and Lara Baticic
Gastrointest. Disord. 2025, 7(2), 33; https://doi.org/10.3390/gidisord7020033 - 30 Apr 2025
Viewed by 4479
Abstract
Gastroesophageal reflux disease (GERD) is a common chronic gastrointestinal disorder that greatly influences patients’ quality of life and represents a growing public health concern. Characterized by typical and atypical symptoms, GERD encompasses a range of clinical phenotypes and is associated with complications such [...] Read more.
Gastroesophageal reflux disease (GERD) is a common chronic gastrointestinal disorder that greatly influences patients’ quality of life and represents a growing public health concern. Characterized by typical and atypical symptoms, GERD encompasses a range of clinical phenotypes and is associated with complications such as erosive esophagitis and Barrett’s esophagus. This review intends to provide a thorough overview of current scientific knowledge on the etiological factors, risk determinants, and pathophysiology of GERD, while exploring diagnostic challenges and therapeutic approaches. Proton pump inhibitors (PPIs) remain the mainstay of medical therapy; however, concerns regarding their long-term safety have encouraged interest in adjunctive and alternative strategies. Emerging pharmacological agents, plant-based treatments, and integrative approaches rooted in traditional medicine offer promising modalities for enhanced management. Additionally, dietary and lifestyle modifications such as weight control, meal timing, and avoidance of trigger foods, are essential components of effective care. A multidisciplinary framework incorporating pharmacological, nutritional, and behavioral strategies is emphasized as the most reliable path toward personalized and sustainable GERD management. This review further aims to synthesize current therapeutic modalities and evolving perspectives in the treatment of GERD. Full article
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29 pages, 6986 KiB  
Article
A Non-Pharmacological Paradigm Captures the Complexity in the Mechanism of Action of Poliprotect Against Gastroesophageal Reflux Disease and Dyspepsia
by Sara Caterbi, Claudio Buttarini, Stefano Garetto, Isabelle Franco Moscardini, Stefano Ughetto, Angela Guerrini, Elena Panizzi, Cristiano Rumio, Laura Mattioli, Marina Perfumi, Anna Maidecchi, Andrea Cossu, Stanislas Bruley des Varannes, Jaroslaw Regula, Peter Malfertheiner, Claudia Sardi and Jacopo Lucci
Int. J. Mol. Sci. 2025, 26(3), 1181; https://doi.org/10.3390/ijms26031181 - 29 Jan 2025
Viewed by 2137
Abstract
When the protective mechanisms of the gastroesophageal mucosa are overwhelmed by injurious factors, the structural and functional mucosal integrity is compromised, resulting in a wide spectrum of disorders. Poliprotect has recently been shown to be non-inferior to standard-dose omeprazole for the treatment of [...] Read more.
When the protective mechanisms of the gastroesophageal mucosa are overwhelmed by injurious factors, the structural and functional mucosal integrity is compromised, resulting in a wide spectrum of disorders. Poliprotect has recently been shown to be non-inferior to standard-dose omeprazole for the treatment of endoscopy-negative patients with heartburn and/or epigastric pain or burning. Here, we provide preclinical data describing the mechanism of action of the Poliprotect formulation, a 100% natural, biodegradable, and environmental friendly medical device according to EU 2017/745 and containing UVCB (unknown or variable composition, complex-reaction products, or biological materials) substances of botanical and mineral origin, according to the REACH and European Chemical Agency definitions. Different in vitro assays demonstrated the capability of Poliprotect to adhere to mucus-secreting gastric cells and concomitantly deliver a local barrier with buffering and antioxidant activity. In studies conducted in accordance with systems biology principles, we evaluated the effects of this barrier on human gastric cells exposed to acidic stress. Biological functions identified via Ingenuity Pathway Analysis highlighted the product’s ability to create a microenvironment that supports the mucosal structural and functional integrity, promotes healing, and restores a balanced mucosal inflammatory status. Additionally, transepithelial electrical resistance and an Ussing chamber showed the product’s capability of preserving the integrity of the gastric and esophageal epithelial barriers when exposed to an acid solution. Two in vivo models of erosive gastropathy further highlighted its topical protection against ethanol- and drug-induced mucosal injury. Overall, our findings sustain the feasibility of a paradigm shift in therapeutics R&D by depicting a very innovative and desirable mode of interaction with the human body based on the emerging biophysical, rather than the pharmacological properties of these therapeutic agents. Full article
(This article belongs to the Special Issue Natural Compounds for Counteracting GI and Liver Diseases)
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11 pages, 2369 KiB  
Article
Preference for On-Demand Fexuprazan Therapy in Gastroesophageal Reflux Disease: A Prospective Cohort Study
by Byung Wook Jung, Chan Hyuk Park and Chang Soo Eun
J. Pers. Med. 2025, 15(1), 19; https://doi.org/10.3390/jpm15010019 - 6 Jan 2025
Viewed by 1556
Abstract
Introduction: Maintenance therapy is crucial in managing and preventing symptom relapse in gastroesophageal reflux disease (GERD), with continuous and on-demand therapy being the common approaches. However, maintenance therapy using potassium-competitive acid blockers (P-CABs), such as fexuprazan, remains incompletely evaluated. Methods: This single-center, single-arm, [...] Read more.
Introduction: Maintenance therapy is crucial in managing and preventing symptom relapse in gastroesophageal reflux disease (GERD), with continuous and on-demand therapy being the common approaches. However, maintenance therapy using potassium-competitive acid blockers (P-CABs), such as fexuprazan, remains incompletely evaluated. Methods: This single-center, single-arm, prospective cohort study enrolled individuals with weekly heartburn or acid regurgitation and confirmed erosive esophagitis. The participants received 40 mg fexuprazan daily for 4 weeks as initial therapy, followed by 4 weeks of maintenance therapy. Patients chose either continuous or on-demand therapy for maintenance, according to their preference. The primary endpoint was the proportion of patients selecting on-demand therapy. The symptom scores were assessed using the GERD questionnaire (GERD-Q) and patient assessment of upper-gastrointestinal-disorders symptoms questionnaire (PAGI-SYM). Results: The 31 included participants showed a significant reduction in symptom scores after initial treatment (baseline vs. 4-week: GERD-Q, 9.0 vs. 6.5, p < 0.001; PAGI-SYM, 29.0 vs. 10.8, p < 0.001). Twenty-one (67.7%) patients chose on-demand therapy after initial treatment. The symptom scores did not differ significantly before and after maintenance therapy (4-week vs. 8-week: GERD-Q, 6.5 vs. 6.0, p = 0.225; PAGI-SYM, 10.8 vs. 9.0, p = 0.354). Although this relation was not significant, patients experiencing larger decreases in symptom scores tended to prefer on-demand therapy. After maintenance therapy, the symptom scores did not differ between continuous and on-demand therapy (GERD-Q, 5.3 vs. 6.3, p = 0.342; PAGI-SYM, 9.4 vs. 8.8, p = 0.611). Conclusions: Fexuprazan was effective as an initial and maintenance therapy in patients with GERD who showed typical symptoms. Approximately 68% of the patients preferred on-demand therapy as a maintenance treatment. Based on the patient’s preference for maintenance therapy, symptom control did not differ between continuous and on-demand therapy. Full article
(This article belongs to the Section Personalized Therapy and Drug Delivery)
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8 pages, 2248 KiB  
Case Report
Diagnostic Difficulties of Erosive Lichen Planus in a Pediatric Patient
by Carolyn Szwed, Olivia Gudziewski, Marta Sar-Pomian, Malgorzata Olszewska, Lidia Rudnicka and Joanna Czuwara
Diagnostics 2025, 15(1), 35; https://doi.org/10.3390/diagnostics15010035 - 27 Dec 2024
Viewed by 1095
Abstract
Background: Lichen planus (LP) is a chronic inflammatory disease that can present with significant morbidity, particularly in children. Erosive lichen planus (ELP), its rare destructive subtype, can be particularly difficult to diagnose and manage. We present a rare pediatric case of ELP with [...] Read more.
Background: Lichen planus (LP) is a chronic inflammatory disease that can present with significant morbidity, particularly in children. Erosive lichen planus (ELP), its rare destructive subtype, can be particularly difficult to diagnose and manage. We present a rare pediatric case of ELP with multisite involvement and discuss the differential diagnosis. Case Presentation: A 12-year-old boy presented with painful erosions and ulcers on the lateral tongue and dystrophic nails. His six-year history of tongue and nail lesions prompted several comprehensive examinations. Laboratory tests did not reveal any abnormalities. Histopathological examination of the tongue lesions was representative of ELP. Line-field confocal optical coherence tomography (LC-OCT) examination of the tongue lesions showed features that strongly correlated with histopathology. The patient was later hospitalized due to dysphagia and esophageal food impaction, during which esophageal ELP was confirmed. The patient was initially managed with topical corticosteroids. He was later started on systemic therapy in the form of methotrexate and low-dose naltrexone to address his symptoms and disease presentation. Conclusions: This case highlights the complexities of diagnosis and management of ELP in pediatric patients. A multidisciplinary approach and regular follow-up are necessary to manage symptoms, prevent complications, and improve quality of life. Full article
(This article belongs to the Special Issue Dermatopathology and the Diagnosis of Skin Diseases)
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1 pages, 138 KiB  
Retraction
RETRACTED: Jeong et al. 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
by Yuchul Jeong, Beom Jun Lee and Se-Hyeon Han
J. Clin. Med. 2024, 13(21), 6388; https://doi.org/10.3390/jcm13216388 - 25 Oct 2024
Viewed by 1064
Abstract
The Journal of Clinical Medicine retracts the article entitled “A Phase III Head-to-Head Study to Compare the Efficacy and Safety of Fexuprazan and Esomeprazole in Treating Patients with Erosive Esophagitis” [...] Full article
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
10 pages, 431 KiB  
Article
IL-8, TNF-α, and IL-17 in the Development of Erosive Esophagitis and Symptom Perception in Gastroesophageal Reflux Disease (GERD)
by Titong Sugihartono, Amal Arifi Hidayat, Ricky Indra Alfaray, Michael Austin Pradipta Lusida, Isna Mahmudah, Hafeza Aftab, Ratha-Korn Vilaichone, Yoshio Yamaoka, Hoda M. Malaty and Muhammad Miftahussurur
J. Clin. Med. 2024, 13(19), 5832; https://doi.org/10.3390/jcm13195832 - 29 Sep 2024
Cited by 2 | Viewed by 1654
Abstract
Background: The diverse clinical characteristics of erosive esophagitis (EE) and symptom perception in patients with gastroesophageal reflux disease (GERD) remain a major challenge in understanding their underlying pathogenesis. This study aimed to investigate the association between the levels of IL-8, TNF-α, and IL-17 [...] Read more.
Background: The diverse clinical characteristics of erosive esophagitis (EE) and symptom perception in patients with gastroesophageal reflux disease (GERD) remain a major challenge in understanding their underlying pathogenesis. This study aimed to investigate the association between the levels of IL-8, TNF-α, and IL-17 in serum and the presence of erosive esophagitis and symptoms related to GERD. Method: We enrolled 65 subjects presenting with GERD symptoms. Based on the findings of upper endoscopy, the subjects were categorized into two groups: (1) erosive esophagitis (EE LA grades B-D) and (2) non-erosive esophagitis (normal-EE LA grade A). Symptom perception was assessed via GERD questionnaire (GERD-Q) and the frequency scale for the symptoms of GERD (FSSG). The enzyme-linked immunosorbent assay (ELISA) method was used to analyze serum levels of IL-8, TNF-α, and IL-17. Analysis of cytokine levels between different symptoms severity was performed using the Kruskal-Wallis H test. Results: Median serum IL-8 levels were significantly higher in the erosive esophagitis group compared to those with non-erosive esophagitis (20.2 (IQR 16.9–32.2) vs. 17.7 (IQR 15.2–19.6), p < 0.05). The study found a significant association between IL-8 levels and the presence of globus symptoms (median IL8 level 46.961 (38.622–92.644) in subjects with globus vs. 18.06 (16.68–20.49) in those without globus; p < 0.05). Similarly, TNF-α levels were associated with the frequency of regurgitation symptoms (H index = 10.748; dr = 3; p < 0.05). We observed a significant correlation between IL-17 levels and the frequency of heartburn and early satiety symptoms. Conclusions: IL-8 may play a role in the development of mucosal erosion in GERD. IL-8, TNF- α, and IL-17 might be involved in the development of globus symptoms, the frequency of regurgitation, and the frequency of heartburn and early satiety, respectively. The diverse symptom phenotypes observed in patients with GERD symptoms may be mediated by distinct profiles of proinflammatory cytokines. Full article
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
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14 pages, 1817 KiB  
Article
Comparison between Conventional and Simple Measuring Methods of Mean Nocturnal Baseline Impedance in Pediatric Gastroesophageal Reflux Disease
by Radu Samuel Pop, Lăcrămioara Eliza Chiperi, Vlad-Ionuț Nechita, Sorin Claudiu Man and Dan Lucian Dumitrașcu
Clin. Pract. 2024, 14(5), 1682-1695; https://doi.org/10.3390/clinpract14050134 - 27 Aug 2024
Viewed by 1563
Abstract
(1) Background: Multichannel intraluminal impedance–pH (MII-pH) monitoring is commonly used to diagnose gastroesophageal reflux disease (GERD). The mean nocturnal baseline impedance (MNBI) is an important parameter, reflecting the esophageal mucosal integrity and improvement in GERD. This study aims to evaluate the correlation between [...] Read more.
(1) Background: Multichannel intraluminal impedance–pH (MII-pH) monitoring is commonly used to diagnose gastroesophageal reflux disease (GERD). The mean nocturnal baseline impedance (MNBI) is an important parameter, reflecting the esophageal mucosal integrity and improvement in GERD. This study aims to evaluate the correlation between conventionally measured MNBI and a recently described simple MNBI measurement method in diagnosing pediatric GERD. (2) Methods: This prospective observational study enrolled 64 children aged one month to 18 years who underwent 24 h MII-pH monitoring. Conventional MNBI was measured during stable 10 min intervals at night, while the simple MNBI method averaged impedance throughout the nocturnal supine period. (3) Results: Strong correlations were found between conventional and simple MNBI values across all impedance channels in both infants (r > 0.85) and older children (r > 0.9). Conventional and simple MNBIs in the most distal channel (Z6) effectively differentiated non-erosive reflux disease (NERD) from other phenotypes, with AUCs of 0.864 and 0.860, respectively. The simple MNBI demonstrated good diagnostic performance with similar sensitivity and specificity to the conventional MNBI. (4) Conclusions: Including MNBI measurements into routine MII-pH monitoring may enhance GERD diagnosis and reduce the need for more invasive procedures. Full article
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15 pages, 1440 KiB  
Article
Enhanced Risk of Gastroesophageal Reflux Disease and Esophageal Complications in the Ulcerative Colitis Population
by Xiaoliang Wang, Omar Almetwali, Jiayan Wang, Zachary Wright, Eva D. Patton-Tackett, Stephen Roy, Lei Tu and Gengqing Song
J. Clin. Med. 2024, 13(16), 4783; https://doi.org/10.3390/jcm13164783 - 14 Aug 2024
Viewed by 1838
Abstract
Background: Although heartburn and reflux are frequently reported in ulcerative colitis [UC], the correlation between UC and gastroesophageal reflux disease [GERD], and its complications, esophageal stricture and Barrett’s esophagus [BE], is not well understood. This study aims to examine the prevalence and [...] Read more.
Background: Although heartburn and reflux are frequently reported in ulcerative colitis [UC], the correlation between UC and gastroesophageal reflux disease [GERD], and its complications, esophageal stricture and Barrett’s esophagus [BE], is not well understood. This study aims to examine the prevalence and associated risk of GERD and its complications within the UC population. Methods: We analyzed the National Inpatient Sample (NIS) dataset, consisting of 7,159,694 patients, comparing GERD patients with and without UC to those without GERD. We assessed the degree of colonic involvement in UC and the occurrence of esophageal complications. Bivariate analyses were conducted using the chi-squared test or Fisher exact test (two-tailed). Results: A higher prevalence of GERD (23.0% vs. 16.5%) and GERD phenotypes, such as non-erosive reflux disease (NERD) (22.3% vs. 16%) and erosive esophagitis (EE) (1.2% vs. 0.6%), was found in UC patients (p < 0.01), including pancolitis, proctitis, proctosigmoiditis, left-sided colitis, and indetermined UC (with undefined colonic involvement). UC patients were more likely to develop GERD (1.421), NERD (1.407), and EE (1.681) (p < 0.01). A higher prevalence of esophageal stricture (16.9 vs. 11.4 per 10,000 patients) and BE without dysplasia (94.5 vs. 39.3 per 10,000 patients) was found in UC (p < 0.05). The odds of developing BE without dysplasia were higher (1.892) in patients with UC (p < 0.01), including ulcerative pancolitis, proctitis, and indeterminate UC (OR of 1.657, 3.328, and 1.996, respectively) (p < 0.05). Conclusions: Our study demonstrates an increased risk of developing GERD and its complications in UC. This highlights the importance of vigilant monitoring and early intervention to minimize associated GERD-related risks in patients with UC. Full article
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
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30 pages, 5739 KiB  
Article
In Vitro Metabolism and Transport Characteristics of Zastaprazan
by Min Seo Lee, Jihoon Lee, Minyoung Pang, John Kim, Hyunju Cha, Banyoon Cheon, Min-Koo Choi, Im-Sook Song and Hye Suk Lee
Pharmaceutics 2024, 16(6), 799; https://doi.org/10.3390/pharmaceutics16060799 - 13 Jun 2024
Cited by 6 | Viewed by 2706
Abstract
Zastaprazan (JP-1366), a novel potassium-competitive acid blocker, is a new drug for the treatment of erosive esophagitis. JP-1366 is highly metabolized in human, mouse, and dog hepatocytes but moderately metabolized in rat and monkey hepatocytes when estimated from the metabolic stability of this [...] Read more.
Zastaprazan (JP-1366), a novel potassium-competitive acid blocker, is a new drug for the treatment of erosive esophagitis. JP-1366 is highly metabolized in human, mouse, and dog hepatocytes but moderately metabolized in rat and monkey hepatocytes when estimated from the metabolic stability of this compound in hepatocyte suspension and when 18 phase I metabolites and 5 phase II metabolites [i.e., N-dearylation (M6), hydroxylation (M1, M19, M21), dihydroxylation (M7, M8, M14, M22), trihydroxylation (M13, M18), hydroxylation and reduction (M20), dihydroxylation and reduction (M9, M16), hydrolysis (M23), hydroxylation and glucuronidation (M11, M15), hydroxylation and sulfation (M17), dihydroxylation and sulfation (M10, M12), N-dearylation and hydroxylation (M3, M4), N-dearylation and dihydroxylation (M5), and N-dearylation and trihydroxylation (M2)] were identified from JP-1366 incubation with the hepatocytes from humans, mice, rats, dogs, and monkeys. Based on the cytochrome P450 (CYP) screening test and immune-inhibition analysis with CYP antibodies, CYP3A4 and CYP3A5 played major roles in the metabolism of JP-1366 to M1, M3, M4, M6, M8, M9, M13, M14, M16, M18, M19, M21, and M22. CYP1A2, 2C8, 2C9, 2C19, and 2D6 played minor roles in the metabolism of JP-1366. UDP-glucuronosyltransferase (UGT) 2B7 and UGT2B17 were responsible for the glucuronidation of M1 to M15. However, JP-1366 and active metabolite M1 were not substrates for drug transporters such as organic cation transporter (OCT) 1/2, organic anion transporter (OAT) 1/3, organic anion transporting polypeptide (OATP)1B1/1B3, multidrug and toxic compound extrusion (MATE)1/2K, P-glycoprotein (P-gp), and breast cancer-resistant protein (BCRP). Only M1 showed substrate specificity for P-gp. The findings indicated that drug-metabolizing enzymes, particularly CYP3A4/3A5, may have a significant role in determining the pharmacokinetics of zastaprazan while drug transporters may only have a small impact on the absorption, distribution, and excretion of this compound. Full article
(This article belongs to the Section Pharmacokinetics and Pharmacodynamics)
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13 pages, 2067 KiB  
Article
RETRACTED: A Phase III Head-to-Head Study to Compare the Efficacy and Safety of Fexuprazan and Esomeprazole in Treating Patients with Erosive Esophagitis
by Yuchul Jeong, Beom Jun Lee and Se-Hyeon Han
J. Clin. Med. 2024, 13(11), 3262; https://doi.org/10.3390/jcm13113262 - 31 May 2024
Cited by 2 | Viewed by 3995 | Retraction
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®; [...] Read more.
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. Full article
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12 pages, 1243 KiB  
Article
An Evaluation of the Efficacy and Safety of TAMIXAM®, Based on Hyaluronic Acid and Tamarind Seed Extract, for Esophageal Mucosal Protection from Acid Insult
by Marisa Francesca Motta, Giuseppe Pulitano, Antonino Bagnulo, Giampaolo Buriani, Umberto Di Maio, Fabio Amone, Vincenzo Nobile and Rocco Malivindi
Gastrointest. Disord. 2024, 6(1), 202-213; https://doi.org/10.3390/gidisord6010015 - 18 Feb 2024
Viewed by 2591
Abstract
TAMIXAM® is a novel technology that combines hyaluronic acid and tamarind seed extract in its formulation. It is designed to protect the esophageal mucosa by creating a barrier through its filmogenic properties. The aim of this study is to evaluate the safety [...] Read more.
TAMIXAM® is a novel technology that combines hyaluronic acid and tamarind seed extract in its formulation. It is designed to protect the esophageal mucosa by creating a barrier through its filmogenic properties. The aim of this study is to evaluate the safety and efficacy of this technology through mucoadhesion tests, a cell viability assay, TEER measurements, and morphological analysis on reconstructed esophageal mucosa exposed to 10% hydrochloric acid before and after treatment. The mucoadhesion test highlighted the synergistic bioadhesive effect of the technology’s components. Cell viability assays revealed the substantial mucoprotective and barrier effects of the technology, preserving tissue viability when applied before exposure to acid insult. A morphological analysis illustrated TAMIXAM®’s efficacy in countering acid-induced damage, reducing erosion, necrosis, and tissue degeneration compared to the positive control, both pre- and post-acid insult. An evaluation of epithelial integrity through TEER measurements indicated a minimal reduction in tissues treated with the invention before acid exposure, demonstrating its ability to maintain epithelial integrity in the presence of an acid insult. However, this effect was less pronounced in tissues treated with the technology after the acid insult, implying a potential partial recovery of epithelial integrity. Furthermore, comprehensive in vitro and in vivo studies supported the safety profile of the invention. In conclusion, TAMIXAM® emerged as a compelling solution, providing enhanced mechanical action to maintain epithelial balance and shield the esophageal mucosa from acid-induced damage. Full article
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11 pages, 1657 KiB  
Systematic Review
GERD as a Complication of Laparoscopic Sleeve Gastrectomy for the Treatment of Obesity: A Systematic Review and Meta-Analysis
by Przemysław Znamirowski, Magdalena Kołomańska, Robert Mazurkiewicz, Oksana Tymchyshyn and Łukasz Nawacki
J. Pers. Med. 2023, 13(8), 1243; https://doi.org/10.3390/jpm13081243 - 10 Aug 2023
Cited by 14 | Viewed by 2472
Abstract
Introduction: The incidence of obesity is increasing in developed societies, and surgical treatment is one treatment option. The most common surgical treatment for obesity is laparoscopic sleeve gastrectomy (LSG). Gastroesophageal reflux disease (GERD) is a complication of both obesity and the surgical treatment [...] Read more.
Introduction: The incidence of obesity is increasing in developed societies, and surgical treatment is one treatment option. The most common surgical treatment for obesity is laparoscopic sleeve gastrectomy (LSG). Gastroesophageal reflux disease (GERD) is a complication of both obesity and the surgical treatment of obesity. Materials and methods: In this study, the PubMed database was searched using the keywords “GERD” and “bariatric surgery”, and 987 papers published between 1 July 2017 and 30 June 2022 were retrieved. Results: Nine papers met the inclusion criteria and were included in the meta-analysis. The articles were analyzed for the de novo occurrence of GERD after the treatment of its symptoms, the occurrence of erosive esophagitis, and Barrett’s esophagus. In addition, interesting conclusions are presented from the papers that did not meet the inclusion criteria but shed light on the pathophysiology of GERD in obese patients undergoing LSG. Conclusion: In conclusion, the authors draw attention to the need for endoscopic surveillance in patients undergoing LSG, even in the absence of clinical signs of GERD. Full article
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15 pages, 1162 KiB  
Article
Differences in Dietary and Lifestyle Triggers between Non-Erosive Reflux Disease and Reflux Esophagitis—A Multicenter Cross-Sectional Survey in China
by Yang Chen, Xiaohong Sun, Wenjuan Fan, Jiao Yu, Peng Wang, Dong Liu, Mingwei Song, Shi Liu, Xiuli Zuo, Rong Zhang, Yuantao Hou, Shaomei Han, Yanqing Li, Jun Zhang, Xiaoqing Li, Meiyun Ke and Xiucai Fang
Nutrients 2023, 15(15), 3400; https://doi.org/10.3390/nu15153400 - 31 Jul 2023
Cited by 4 | Viewed by 3800
Abstract
The occurrence of gastroesophageal reflux disease (GERD) and symptom onset are closely associated with diet. We aimed to compare the dietary and lifestyle triggers between non-erosive reflux disease (NERD) and reflux esophagitis (RE) in Chinese patients and to provide evidence for development of [...] Read more.
The occurrence of gastroesophageal reflux disease (GERD) and symptom onset are closely associated with diet. We aimed to compare the dietary and lifestyle triggers between non-erosive reflux disease (NERD) and reflux esophagitis (RE) in Chinese patients and to provide evidence for development of practical dietary modifications for GERD. A multicenter cross-sectional survey was conducted. A total of 396 GERD patients with typical gastroesophageal reflux symptoms who received upper endoscopy in the previous month were enrolled, including 203 cases of NERD patients and 193 cases of RE patients. All participants completed questionnaires including demographic data, reflux symptoms, previous management, dietary and lifestyle habits, triggers of reflux symptoms, psychological status, and quality of life. There were no significant differences in GERD symptom scores between NERD and RE. RE patients had a higher male proportion and smoking/drinking and overeating rates than NERD patients. In the NERD group, more patients reported that fruits, dairy products, yogurt, bean products, cold food, and carbonated beverages sometimes and often induced reflux symptoms and had more triggers compared to RE patients. The number of triggers was positively correlated to GERD symptom score and GERD-HRQL score in both NERD and RE patients. However, 74.0% of GERD patients still often consumed the triggering foods, even those foods that sometimes and often induced their reflux symptoms, which might be related to the reflux relapse after PPI withdrawal considering NERD and RE patients had similar GERD symptom severity. There were some differences in terms of dietary habits, dietary and lifestyle triggers, and related quality of life between NERD and RE, and these results may provide evidence of different approaches toward the dietary modification of NERD and RE patients. Full article
(This article belongs to the Special Issue Dietary Habits and Metabolic Health)
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