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Journal of Gastroenterology and... Apr 2024Fexuprazan is a novel potassium-competitive acid blocker (P-CAB). This study aimed to explore the noninferior efficacy and safety of fexuprazan to esomeprazole in... (Comparative Study)
Comparative Study Randomized Controlled Trial
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.
Topics: Humans; Amines; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Gastroesophageal Reflux; Peptic Ulcer; Proton Pump Inhibitors; Pyrroles; Treatment Outcome
PubMed: 38251791
DOI: 10.1111/jgh.16471 -
Annales D'endocrinologie Sep 2019Acromegaly causes multiple comorbidities, including gastrointestinal disorders. The present study evaluated the frequency of hiatal hernia and other upper...
PURPOSE
Acromegaly causes multiple comorbidities, including gastrointestinal disorders. The present study evaluated the frequency of hiatal hernia and other upper gastrointestinal pathologies in patients with acromegaly, given that visceromegaly and reduced nitric oxide levels in acromegaly may impact diaphragm and lower esophageal sphincter function and thus possibly the development of hiatal hernia.
METHODS
Thirty-nine acromegaly patients followed our center for the previous 6months were recruited. Upper gastrointestinal endoscopy was performed once in all patients to evaluate hiatal hernia, esophagitis, gastroduodenitis and ulcer.
RESULTS
Twenty-three patients were male and 16 female. Upper gastrointestinal endoscopy found hiatal hernia, esophagitis and gastroduodenitis or gastric ulcer in 3 (7.6%), 2 (1.7%) and 31 (79.4%) patients, respectively. Pathologic examination of gastric antrum biopsy found intestinal metaplasia in 12 (30.7%) patients, and Helicobacter pylori was positive in 13 (33.3%). There were no significant correlations between age, gender, disease duration or preoperative adenoma size on the one hand and hiatal hernia or other endoscopic findings on the other. Similarly, neither surgical success nor recurrence was associated with endoscopic findings.
CONCLUSIONS
The study showed that prevalence of gastritis, duodenitis, peptic ulcer and intestinal metaplasia is higher and prevalence of hiatal hernia lower in acromegaly patients than in the healthy population. Various unknown disease-related pathophysiological conditions may play a role; there is a need for further studies.
Topics: Acromegaly; Adult; Endoscopy, Gastrointestinal; Esophagitis; Female; Gastritis; Gastrointestinal Diseases; Hernia, Hiatal; Humans; Male; Middle Aged; Peptic Ulcer; Prevalence; Upper Gastrointestinal Tract
PubMed: 31227172
DOI: 10.1016/j.ando.2019.03.001 -
Revista Espanola de Enfermedades... Dec 2022A 66-year-old man with a history of tobacco and alcohol consumption was diagnosed with a severe peptic esophagitis. After treatment, an endoscopy showed the resolution...
A 66-year-old man with a history of tobacco and alcohol consumption was diagnosed with a severe peptic esophagitis. After treatment, an endoscopy showed the resolution of esophagitis, but revealed white multinodular plaques with a diffuse distribution. Histology showed esophageal mucosa with a prominent granular layer and hyperorthokeratotis, in keeping with epidermoid metaplasia. This unusual condition has been linked to esophageal squamous cell carcinoma. Therefore, diagnosis and endoscopic surveillance should be considered.
Topics: Male; Humans; Aged; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Esophageal Diseases; Metaplasia
PubMed: 35240851
DOI: 10.17235/reed.2022.8708/2022 -
Medicine Oct 2022Absent contractility is a rare esophageal motility disorder defined by high-resolution manometry which remains poorly understood in pathogenesis and management. We...
Absent contractility is a rare esophageal motility disorder defined by high-resolution manometry which remains poorly understood in pathogenesis and management. We investigated the clinical symptoms, upper gastrointestinal endoscopy findings, and lower esophageal sphincter (LES) characteristics in adult patients diagnosed with absent contractility on high resolution manometry and factors associated with erosive esophagitis that were found on endoscopy in these patients. A cross-sectional study was conducted in patients with absent contractility who were examined at the Institute of Gastroenterology and Hepatology, Vietnam between March 2018 and December 2020. Clinical symptoms, endoscopic findings, and LES metrics were collected and compared between individuals with and without erosive esophagitis. Logistic regression analysis was used to examine a variety of factors associated with erosive esophagitis. Among 7519 patients who underwent high resolution manometry, 204 (2.7%) were diagnosed with absent contractility. The mean age of the study sample was 45.9 years, 65.7% were women, and none had systemic sclerosis. The most common symptoms were regurgitation, belching, epigastric pain, and bloating. On endoscopy, 50% had erosive esophagitis, mostly Los Angeles grade A (42.9%). On manometry, 44.6% of the patients had LES hypotension and 68.1% had low integrated relaxation pressure in 4 seconds (IRP4s). Male sex (adjusted odds ratio = 2.01, 95% confidence interval: 1.04-3.89) and an IRP4s < 5 mm Hg (adjusted odds ratio = 2.21, 95% confidence interval: 1.12-4.37) were significantly associated with erosive esophagitis. Absent contractility was present in many patients without known systemic diseases. Erosive esophagitis was common and associated with male sex and low IRP4s.
Topics: Adult; Humans; Male; Female; Middle Aged; Esophageal Sphincter, Lower; Gastroesophageal Reflux; Cross-Sectional Studies; Manometry; Esophagitis; Peptic Ulcer; Endoscopy, Gastrointestinal
PubMed: 36316894
DOI: 10.1097/MD.0000000000031428 -
Gastroenterology Jun 2023For patients with achalasia experiencing persistent or recurrent symptoms after laparoscopic Heller myotomy (LHM), pneumatic dilation (PD) is the most frequently used... (Randomized Controlled Trial)
Randomized Controlled Trial
The Efficacy of Peroral Endoscopic Myotomy vs Pneumatic Dilation as Treatment for Patients With Achalasia Suffering From Persistent or Recurrent Symptoms After Laparoscopic Heller Myotomy: A Randomized Clinical Trial.
BACKGROUND & AIMS
For patients with achalasia experiencing persistent or recurrent symptoms after laparoscopic Heller myotomy (LHM), pneumatic dilation (PD) is the most frequently used treatment. Per-oral endoscopic myotomy (POEM) is increasingly being investigated as rescue therapy. This study aimed to determine the efficacy of POEM vs PD for patients with persistent or recurrent symptoms after LHM.
METHODS
This randomized multicenter controlled trial included patients after LHM with an Eckardt score >3 and substantial stasis (≥2 cm) on timed barium esophagogram and randomized to POEM or PD. The primary outcome was treatment success, defined as an Eckardt score of ≤3 and without unscheduled re-treatment. Secondary outcomes included the presence of reflux esophagitis, high-resolution manometry, and timed barium esophagogram findings. Follow-up duration was 1 year after initial treatment.
RESULTS
Ninety patients were included. POEM had a higher success rate (28 of 45 patients [62.2%]) than PD (12 of 45 patients [26.7%]; absolute difference, 35.6%; 95% CI, 16.4%-54.7%; P = .001; odds ratio, 0.22; 95% CI, 0.09-0.54; relative risk for success, 2.33; 95% CI, 1.37-3.99). Reflux esophagitis was not significantly different between POEM (12 of 35 [34.3%]) and PD (6 of 40 [15%]). Basal lower esophageal sphincter pressure and integrated relaxation pressure (IRP-4) were significantly lower in the POEM group (P = .034; P = .002). Barium column height after 2 and 5 minutes was significantly less in patients treated with POEM (P = .005; P = .015).
CONCLUSIONS
Among patients with achalasia experiencing persistent or recurrent symptoms after LHM, POEM resulted in a significantly higher success rate than PD, with a numerically higher incidence of grade A-B reflux esophagitis.
NETHERLANDS TRIAL REGISTRY
NL4361 (NTR4501), https://trialsearch.who.int/Trial2.aspx?TrialID = NTR4501.
Topics: Humans; Esophageal Achalasia; Heller Myotomy; Esophageal Sphincter, Lower; Dilatation; Barium; Treatment Outcome; Esophagitis, Peptic; Natural Orifice Endoscopic Surgery
PubMed: 36907524
DOI: 10.1053/j.gastro.2023.02.048 -
Annals of the New York Academy of... Dec 2020Gastroesophageal reflux disease (GERD) is a complex disorder. Symptoms of heartburn can help find the disorder of GERD. pH testing is the mainstay of evaluation of... (Review)
Review
Gastroesophageal reflux disease (GERD) is a complex disorder. Symptoms of heartburn can help find the disorder of GERD. pH testing is the mainstay of evaluation of symptoms, including 24-h and longer pH studies to detect pathologic acid exposure. The use of proton pump inhibitor (PPI) therapy for approved indications is helpful for both symptomatic relief and esophagitis healing in the majority of patients with abnormal acid exposure. PPI medications are safe in short- or long-term use. It is recommended not to maintain cirrhotic patients on PPI therapy without a meaningful indication. Dietary adjustment can provide benefit to some patients, but the data are mixed on how much benefit has been demonstrated from specific food avoidance. Reduction in weight improves reflux. Obesity has measurable effects on the esophageal acid exposure but fewer effects on the motility of the esophagus itself. Controlling weight and changing lifestyle can be helpful for improving GERD symptoms. For some patients in whom either the control of reflux with medications and lifestyle change is not sufficient or a hernia is contributing to symptom generation, surgical and endosurgical interventions can be considered to help manage reflux after a thorough workup with pH testing and manometry.
Topics: Esophageal pH Monitoring; Esophagitis, Peptic; Esophagus; Gastroesophageal Reflux; Heartburn; Hernia, Hiatal; Humans; Life Style; Manometry; Obesity; Proton Pump Inhibitors
PubMed: 32944973
DOI: 10.1111/nyas.14496 -
Journal of Korean Medical Science Feb 2021The impact of reflux esophagitis on the decline of lung function has been rarely reported. This study was performed to evaluate the association between erosive reflux...
BACKGROUND
The impact of reflux esophagitis on the decline of lung function has been rarely reported. This study was performed to evaluate the association between erosive reflux esophagitis and lung function changes.
METHODS
We included patients with normal lung function who underwent esophagogastroduodenoscopy for health screening from a health screening center. Patients with persistent erosive reflux esophagitis on two discrete endoscopic examinations were designated as the erosive reflux esophagitis group. We also selected patients without erosive reflux esophagitis and matched them 1:4 with patients from the erosive reflux esophagitis group. We estimated annual forced expiratory volume in 1 second (FEV₁) and forced vital capacity (FVC) changes from baseline and compared these estimates by the linear mixed regression model. We also estimated the biannual incidence of chronic obstructive pulmonary disease (COPD).
RESULTS
In total, 1,050 patients (210 patients with erosive reflux esophagitis, and 840 matched controls) were included. The median follow-up duration for spirometry was six years. In patients with erosive reflux esophagitis, mild reflux esophagitis (A grade) was most common (165 patients, 78.6%). The adjusted annual FEV₁ change in patients with erosive reflux esophagitis was -51.8 mL/yr, while it decreased by 46.8 mL/yr in controls ( = 0.270). The adjusted annual FVC decline was similar between the two groups (-55.8 vs. -50.5 mL/yr, = 0.215). The estimated COPD incidence during the follow-up period was not different between the erosive reflux esophagitis and control groups.
CONCLUSION
In patients with normal lung function, the presence of erosive reflux esophagitis did not affect the annual declines in FEV₁ or FVC.
Topics: Adult; Case-Control Studies; Endoscopy, Digestive System; Esophagitis, Peptic; Female; Humans; Lung; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Retrospective Studies; Severity of Illness Index; Spirometry; Vital Capacity
PubMed: 33527781
DOI: 10.3346/jkms.2021.36.e29 -
Alimentary Pharmacology & Therapeutics Jul 2023Treatment of acid-related disorders relies on gastric acid suppression. The percentage of time intragastric pH is >4 (pH >4 holding time ratio [HTR]) is important for...
BACKGROUND
Treatment of acid-related disorders relies on gastric acid suppression. The percentage of time intragastric pH is >4 (pH >4 holding time ratio [HTR]) is important for healing erosive oesophagitis; and the pH >6 HTR is critical for eradication of Helicobacter pylori infection, as bacterial replication is active and antibiotic effectiveness is optimised. Vonoprazan, a potassium-competitive acid blocker approved in the USA and other countries, suppresses gastric acid secretion in a predictable, rapid and consistent manner, extended over prolonged periods.
AIM
To explore the relationship between vonoprazan exposure and pH HTR through a pharmacokinetic/pharmacodynamic (PK/PD) model.
METHODS
We pooled data from Phase 1 studies with intragastric pH measurements. Pharmacokinetic profiles were predicted for study participants using an existing population pharmacokinetic model. Pharmacokinetic and pharmacodynamic data were merged, and three direct-link PK/PD models were derived and used to simulate pH HTRs with between-participant variability for pH >4, >5 and >6, for vonoprazan doses of 20 mg once and twice daily.
RESULTS
We used data from five Phase 1 studies to derive the PK/PD model. These included 245 participants (95.1% male, 50.6% Japanese and 49.4% non-Asian). Pre-dose, the mean pH >4 HTR was 6.4%, pH >5 3.2% and pH >6 1.2%. After 7 days of dosing, simulations predicted pH >4 HTRs of 89.7% and 98.1%, and pH >6 HTRs of 53.1% and 75.3%, for vonoprazan 20 mg once and twice daily, respectively.
CONCLUSIONS
Vonoprazan 20 mg once- and twice-daily dosing demonstrated high, dose-dependent, 24-hour intragastric acid control in this PK/PD model, supporting clinical efficacy data in patients with acid-related disorders.
Topics: Humans; Male; Female; Helicobacter Infections; Proton Pump Inhibitors; Helicobacter pylori; Peptic Ulcer; Pyrroles; Esophagitis
PubMed: 37066678
DOI: 10.1111/apt.17510 -
BMC Gastroenterology Feb 2021Erosive reflux esophagitis caused a large clinical spectrum of symptoms. Our aim was to assess the prevalence of extra-esophageal symptoms in individuals with and those...
INTRODUCTION
Erosive reflux esophagitis caused a large clinical spectrum of symptoms. Our aim was to assess the prevalence of extra-esophageal symptoms in individuals with and those without erosive esophagitis in Albania.
METHODS
A case-control study was conducted at the Regional Hospital of Durres, the second main district in Albania, a transitional country in South Eastern Europe, including 248 patients with erosive esophagitis (aged 46.5 ± 16.3 years) and 273 controls (aged 46.4 ± 16.0 years; response rate: 70%) enrolled during the period January 2013-June 2014. Both cases and controls underwent upper endoscopy. Information on socio-demographic characteristics and lifestyle factors was also collected. Binary logistic regression was used to assess the association of erosive esophagitis and extra-esophageal symptoms.
RESULTS
Patients with erosive esophagitis had a higher prevalence of excessive alcohol consumption, smoking, sedentarity, non-Mediterranean diet and obesity compared to their control counterparts (9% vs. 5%, 70% vs. 49%, 31% vs. 17%, 61% vs. 49% and 22% vs. 9%, respectively). Upon adjustment for all socio-demographic characteristics and lifestyle/behavioral factors, there was evidence of a strong association of erosive esophagitis with chronic cough (OR = 3.2, 95% CI = 1.7-5.8), and even more so with laryngeal disorders (OR = 4.4, 95% CI = 2.6-7.5). In all models, the association of erosive esophagitis with any extra-esophageal symptoms was strong and mainly consistent with each of the symptoms separately (fully-adjusted model: OR = 4.6, 95% CI = 2.9-7.3).
CONCLUSION
Our findings indicate that the prevalence of extra-esophageal symptoms is higher among patients with erosive esophagitis in a transitional country characterized conventionally by employment of a Mediterranean diet.
Topics: Adult; Albania; Case-Control Studies; Esophagitis; Esophagitis, Peptic; Gastroesophageal Reflux; Humans; Middle Aged; Risk Factors
PubMed: 33593300
DOI: 10.1186/s12876-021-01658-z -
Alimentary Pharmacology & Therapeutics Aug 2022
Topics: Baclofen; Esophagitis, Peptic; Gastroesophageal Reflux; Humans; Muscle Relaxants, Central
PubMed: 35879890
DOI: 10.1111/apt.17103