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BMC Gastroenterology May 2023VISION is a randomised, phase 4, open-label, parallel-group, multicentre study conducted in 33 centres in Japan. The aim of this study was to assess the long-term safety... (Randomized Controlled Trial)
Randomized Controlled Trial
Randomised clinical trial: 3-year interim analysis results of the VISION trial to evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive oesophagitis.
BACKGROUND
VISION is a randomised, phase 4, open-label, parallel-group, multicentre study conducted in 33 centres in Japan. The aim of this study was to assess the long-term safety of vonoprazan for maintenance treatment of healed erosive oesophagitis versus lansoprazole.
METHODS
Patients with endoscopically diagnosed erosive oesophagitis were randomised 2:1 to once-daily vonoprazan 20 mg or lansoprazole 30 mg, for a 4- to 8-week healing phase. Patients with endoscopically confirmed healing entered a 260-week maintenance phase with a once-daily starting dose of vonoprazan 10 mg or lansoprazole 15 mg. Primary endpoint was change in gastric mucosal histopathology.
RESULTS
Of 208 patients (vonoprazan, n = 139; lansoprazole, n = 69) entering the healing phase, 202 entered the maintenance phase (vonoprazan, n = 135; lansoprazole, n = 67). At 3 years, 109 vonoprazan-treated and 58 lansoprazole-treated patients remained on treatment. Histopathological evaluation of gastric mucosa showed that hyperplasia of parietal, foveolar and G cells was more common with vonoprazan than lansoprazole at week 156 of the maintenance phase. There was no marked increase in the occurrence of parietal, foveolar and G cell hyperplasia among patients in the vonoprazan group from week 48 to week 156. Histopathological evaluation of the gastric mucosa also showed no neoplastic changes in either group. No new safety issues were identified.
CONCLUSIONS
In this interim analysis of VISION, no new safety concerns were identified in Japanese patients with healed erosive oesophagitis receiving vonoprazan or lansoprazole as maintenance treatment for 3 years. (CT.gov identifier: NCT02679508; JapicCTI-163153; Japan Registry of Clinical Trials: jRCTs031180040).
Topics: Humans; Proton Pump Inhibitors; Hyperplasia; Esophagitis; Lansoprazole; Peptic Ulcer; Treatment Outcome; 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Ulcer Agents; Double-Blind Method
PubMed: 37127558
DOI: 10.1186/s12876-023-02772-w -
Current Opinion in Endocrinology,... Jun 2024Potassium-competitive acid blockers (PCABs) represent a new class of compounds for the treatment of acid-related disorders. Recent FDA approval of the PCAB vonoprazan...
PURPOSE OF REVIEW
Potassium-competitive acid blockers (PCABs) represent a new class of compounds for the treatment of acid-related disorders. Recent FDA approval of the PCAB vonoprazan for erosive esophagitis has started an important new approach to acid-related disorders.
RECENT FINDINGS
Compared to conventional proton pump inhibitors (PPIs), PCABs provide more rapid, potent, and sustained suppression of gastric acid with faster and more durable symptom relief. Studies have demonstrated the efficacy of PCABs for erosive esophagitis, nonerosive reflux disease, and peptic ulcer disease including H. pylori. However, the PCAB vonoprazan was only approved in the US as part of combination therapy for eradication of H. pylori. Clinical trials have now demonstrated noninferiority of vonoprazan to lansoprazole for treatment of erosive esophagitis, particularly noting superiority of vonoprazan in patients with severe esophagitis resulting in FDA approval of vonoprazan for treatment of erosive esophagitis. Emerging data suggests a possible utility of vonoprazan for PPI-resistant gastroesophageal reflux disease (GERD) and on-demand therapy for nonerosive reflux disease. Vonoprazan is generally well tolerated but long-term safety data is not well established.
SUMMARY
The PCAB vonoprazan is a newly FDA approved treatment option for erosive esophagitis. Its possible role in PPI-resistant GERD and nonerosive reflux disease warrants further investigation.
PubMed: 38483115
DOI: 10.1097/MED.0000000000000858 -
Journal of Neurogastroenterology and... Jul 2020Gastroesophageal reflux disease (GERD) is a complex disorder with heterogeneous symptoms and a multifaceted pathogenetic basis, which prevent a simple diagnostic... (Review)
Review
Gastroesophageal reflux disease (GERD) is a complex disorder with heterogeneous symptoms and a multifaceted pathogenetic basis, which prevent a simple diagnostic algorithm or any categorical classification. Clinical history, questionnaires and response to proton pump inhibitor (PPI) therapy are insufficient tools to make a conclusive diagnosis of GERD and further investigations are frequently required. The Lyon Consensus goes beyond the previous classifications and defines endoscopic and functional parameters able to establish the presence of GERD. Evidences for reflux include high-grade erosive esophagitis, Barrett's esophagus, and peptic strictures at endoscopy as well as esophageal acid exposure time > 6% on pH-metry or combined pH-impedance monitoring. Even if a normal endoscopy does not exclude GERD, its combination with distal acid exposure time < 4% on off-PPI pH-impedance monitoring provides sufficient evidence refuting this diagnosis. Reflux-symptom association on pH-monitoring provides supportive evidence for reflux-triggered symptoms and may predict a better treatment outcome, when present. Also recommendations to perform pH-impedance "on" or "off" PPI are well depicted. When endoscopy and pH-metry or combined pH-impedance monitoring are inconclusive, adjunctive evidence from biopsy findings (eg, microscopic esophagitis), high-resolution manometry (ie, ineffective esophagogastric barrier and esophageal body hypomotility), and novel impedance metrics, such as mean nocturnal baseline impedance and post-reflux swallow-induced peristaltic wave index, can contribute to better identify patients with GERD. Definition of individual patient phenotype, based on the level of refluxate exposure, mechanism of reflux, efficacy of clearance, underlying anatomy of the esophagogastric junction, and clinical presentation, will lead to manage GERD patients with a tailored approach chosen among different types of therapy.
PubMed: 32606254
DOI: 10.5056/jnm20046 -
Drugs May 2023Keverprazan hydrochloride () is a potassium ion competitive acid blocker that is being developed by Jiangsu Carephar Pharmaceuticals for the treatment of acid-related... (Review)
Review
Keverprazan hydrochloride () is a potassium ion competitive acid blocker that is being developed by Jiangsu Carephar Pharmaceuticals for the treatment of acid-related disease. Keverprazan hydrochloride was recently approved in China for the treatment of adults with reflux oesophagitis or duodenal ulcer. This article summarizes the milestones in the development of keverprazan hydrochloride leading to this first approval for reflux oesophagitis and duodenal ulcer.
Topics: Adult; Humans; Duodenal Ulcer; Esophagitis, Peptic; Helicobacter Infections; China
PubMed: 37074491
DOI: 10.1007/s40265-023-01865-w -
Journal of Visceral Surgery Apr 2023Sleeve gastrectomy (SG) is the most frequently performed operation for morbid obesity in the world. In spite of its demonstrated efficacy, the Achilles' Heel of this... (Review)
Review
Sleeve gastrectomy (SG) is the most frequently performed operation for morbid obesity in the world. In spite of its demonstrated efficacy, the Achilles' Heel of this procedure seems to be either pre-existing or de novo gastro-esophageal reflux disease (GERD) with its potential complications such as peptic esophagitis, Barrett's esophagus and, in the long-term, esophageal adenocarcinoma. According to factual literature, it appears clear that Roux-en-Y gastric bypass is the preferred choice in case of pre-existing GERD or hiatal hernia discovered during preoperative workup for bariatric surgery. Nonetheless, certain authors propose performance of SG with an associated antireflux procedure such as Nissen fundoplication. Strict endoscopic surveillance is recommended after bariatric surgery. Revisional surgery (conversion of SG into Roux-en-Y gastric bypass (RYGB)) is the treatment of choice for patients who develop GERD after SG when conservative treatment (modified lifestyle and proton pump inhibitors) has failed. Lastly, with regard to the risk of esophageal adenocarcinoma after SG, large scale studies with adequate follow-up are necessary to come to factual conclusions. In all cases, the management of this conundrum remains a major technical challenge that has to be taken in consideration in future years, especially because of the current expansion of bariatric surgery.
Topics: Humans; Gastroesophageal Reflux; Gastric Bypass; Obesity, Morbid; Gastrectomy; Adenocarcinoma; Retrospective Studies
PubMed: 36725450
DOI: 10.1016/j.jviscsurg.2023.01.004 -
Best Practice & Research. Clinical... 2022Œsophageal atresia is a rare neonatal malformation consisting in an interruption of the continuity of the œsophagus, with or without a tracheo-œsophageal fistula.... (Review)
Review
Œsophageal atresia is a rare neonatal malformation consisting in an interruption of the continuity of the œsophagus, with or without a tracheo-œsophageal fistula. Although mortality rate is now low and most cases can benefit from successful surgical repair soon after birth, morbidity -specially digestive and nutritional-remains high. Many of the adults born with œsophageal atresia will suffer from dysphagia, gastro-œsophageal reflux and/or œsophageal dysmotility, leading to nutritional consequences and quality of life impairment. Barrett's œsophagus, potential risk of œsophageal cancer as well as risk of anastomotic stenosis and eosinophilic œsophagitis justify transition to adulthood and a lifelong prolonged follow-up.
Topics: Adult; Esophageal Atresia; Esophagitis, Peptic; Humans; Infant, Newborn; Quality of Life; Tracheoesophageal Fistula
PubMed: 35331402
DOI: 10.1016/j.bpg.2021.101771 -
Therapeutic Advances in Gastroenterology 2023Since the discovery of () as the causative organism for gastric and duodenal ulcers four decades ago and subsequent recognition as class 1 gastric carcinogen, countless... (Review)
Review
Since the discovery of () as the causative organism for gastric and duodenal ulcers four decades ago and subsequent recognition as class 1 gastric carcinogen, countless numbers of studies have been conducted and papers published, on the efficacy of various management strategies to eradicate the infection. In adults, a global consensus by the experts in the field concluded that gastritis is an infectious disease and requires treatment irrespective of the presence or absence of symptoms due to the potential for serious complication like peptic ulcer disease and gastric neoplasia. However, although more than half the world's population harbors , these serious complications occur only in a small minority of the infected population, even less so in childhood. More importantly, there is accumulating evidence for beneficial role of against many chronic health conditions, from several epidemiological and laboratory studies. No doubt, eradication therapy is indicated in children with related peptic ulcer disease. Even though the pediatric guidelines from various learned societies recommend against a "test and treat" strategy, this is not always adhered to. With the accumulating evidence of the possible beneficial role of , it is time to pause and think, are we causing more harm than good by eradicating in every child who has this bug?
PubMed: 37361453
DOI: 10.1177/17562848231177610 -
Diseases of the Esophagus : Official... Sep 2023This study aimed to investigate the significance of Hill classification to predict esophagitis, Barrett's esophagus, gastroesophageal reflux disease (GERD)...
This study aimed to investigate the significance of Hill classification to predict esophagitis, Barrett's esophagus, gastroesophageal reflux disease (GERD) symptomatology, and future prescriptions of proton pump inhibitors in clinical practice. A total of 922 patients (546 women and 376 men; mean age 54.3 [SD 18.4] years) who underwent gastroscopy between 2012 and 2015 were analyzed. Patient questionnaire regarding symptoms were compared with endoscopy findings. A medical chart review was done that focused on the prescription of PPIs, additional gastroscopies, and GERD surgery in a 3-year period before the index gastroscopy and in a 6-year period afterward. In patients naïve to PPI prescriptions (n = 466), Hill grade III was significantly associated with esophagitis (AOR 2.20; 95% CI 1.00-4.84) and > 2 PPI prescriptions 6 year after the index gastroscopy (AOR 1.95; 95% CI 1.01-3.75), whereas Hill grade IV was significantly associated with esophagitis (AOR 4.41; 95% CI 1.92-10.1), with Barrett's esophagus (AOR 12.7; 95% CI 1.45-112), with reported heartburn (AOR 2.28; 95% CI 1.10-4.74), and with >2 PPI prescriptions (AOR 2.16; 95% CI 1.02-4.55). In patients 'non-naïve' to PPI prescription (n = 556), only Hill grade IV was significantly associated with esophagitis, reported heartburn, and with >2 PPI prescriptions. The gastroscopic classification in Hill grades III and IV is important in clinical practice because they are associated with esophagitis, Barrett's esophagus, symptoms of GERD, and prescriptions of PPIs, whereas a differentiation between Hill grades I and II is not.
Topics: Male; Humans; Female; Middle Aged; Barrett Esophagus; Esophagitis, Peptic; Heartburn; Gastroesophageal Reflux; Proton Pump Inhibitors
PubMed: 36744860
DOI: 10.1093/dote/doad004 -
Clinical and Experimental Pediatrics Nov 2020Esophageal stricture (ES) is an uncommon clinic entity in pediatrics that may be congenital or acquired in childhood. Acquired noncaustic ES is very rare, and clinical...
BACKGROUND
Esophageal stricture (ES) is an uncommon clinic entity in pediatrics that may be congenital or acquired in childhood. Acquired noncaustic ES is very rare, and clinical features of affected patients are unknown.
PURPOSE
We aimed to evaluate the clinical findings, and outcomes of patients with acquired noncaustic ES to aid physicians in the early referral of patients to gastroenterologists.
METHODS
The medical data of patients with acquired noncaustic ES who were followed in our gastroenterology clinic between January 2009 and December 2019 were reviewed.
RESULTS
Acquired noncaustic ES was found in 12 of the 4,950 patients (0.24%) who underwent endoscopy during the study period. The main symptoms were dysphagia (58.3%), vomiting (33.3%), and chronic anemia (8.3%). Chronic malnutrition and underweight were found in 66.6% of the patients. The most common etiological factors were radiotherapy, peptic reflux, and achalasia (16.6%, each), while chemotherapy, squamous-cell carcinoma (SC) of the esophagus, eosinophilic esophagitis (EoE), esophageal web, epidermolysis bullosa, and esophageal diverticulum (8.2%, each) were the other etiological factors. Patients with EoE underwent endoscopic bougie dilation in addition to steroid use and elimination diet. Patients with epidermolysis bullosa and esophageal web underwent bougie dilation. Patients with peptic reflux-related ES were initially put on antireflux therapy, but during follow-up, one patient required esophageal replacement with colonic interposition. Patients with radiotherapy-related ES recovered with medical therapy. The patient with initially underwent surgical gastrostomy and tumoral mass excision. The patient then received chemotherapy and radiotherapy and underwent jejunal interposition. Patients with achalasia underwent surgical esophagomyotomy.
CONCLUSION
The presence of solid dysphagia, malnutrition, and an associated disease may alert physicians to the presence of ES.
PubMed: 33137248
DOI: 10.3345/cep.2020.00199 -
Digestive Diseases (Basel, Switzerland) 2022Dyspepsia is a very frequent condition, affecting up to 50% of general population. Primary care is the logical setting for starting a management. In treating dyspeptic... (Review)
Review
BACKGROUND
Dyspepsia is a very frequent condition, affecting up to 50% of general population. Primary care is the logical setting for starting a management. In treating dyspeptic patients, it is a crucial point to distinguish between functional problems, common diseases such as reflux esophagitis or peptic ulcer, and life-threatening diseases such as upper gastrointestinal (GI) cancer. In Europe, there are different approaches to this problem. We describe the management of dyspepsia, with a particular focus on relationship between dyspepsia and gastric cancer.
SUMMARY
Initial treatment of dyspepsia includes empirical treatment, noninvasive testing for Helicobacter pylori, and upper GI tract endoscopy. Treatment choice is based on different variables, including alarm signs, patient preference, and possibility to perform a gastroscopy. General practitioners are not allowed in all European nations to order a gastroscopy. This may have some reflection on quality of cure.
KEY MESSAGE
In European countries, there are heterogeneities in terms of gastric cancer incidence, mortality, and quality of cure. Awareness of them is a first step in identifying possible solutions.
Topics: Dyspepsia; Endoscopy, Gastrointestinal; Helicobacter Infections; Helicobacter pylori; Humans; Primary Health Care; Prospective Studies; Stomach Neoplasms
PubMed: 33971660
DOI: 10.1159/000517112