scholarly journals Efficacy of vonoprazan for refractory reflux esophagitis after esophagectomy

2021 ◽  
Author(s):  
Yorinari Ochiai ◽  
Toshiro Iizuka ◽  
Yoshio Hoshihara ◽  
Yugo Suzuki ◽  
Junnosuke Hayasaka ◽  
...  

Background: Refractory reflux esophagitis (RRE), unresponsive to conventional proton-pump inhibitors (PPIs) is a complication in esophagectomy with gastric pull-up. Vonoprazan, a novel potassium-competitive acid blocker, has been available in Japan since 2015. Here, we investigated the efficacy of vonoprazan on PPI-resistant RRE after esophagectomy with gastric pull-up. Methods: This was a single-center retrospective study. We used the revised Los Angeles (r-LA) classification based on the Los Angeles (LA) classification and the modified Los Angeles (m-LA) classification to evaluate abnormal forms of mucosal breaks such as spreading laterally consistently. Patients who underwent esophagectomy with gastric pull-up and had RRE grade B–D as per the r-LA classification, despite using standard dose PPIs or double-dose of rabeprazole, were included. Sixteen patients who switched to vonoprazan (20 mg/day) and 14 patients who continued PPIs were assigned to the vonoprazan and PPI groups, respectively. Endoscopic observations were reviewed by three endoscopists using the r-LA classification to ensure consistent diagnosis, while treatment arm and patient information were blinded to evaluators. We defined mucosal breaks that improved by at least one grade after treatment as improved mucosa and recovery to grade M or N as mucosal healing. Results: The percentage of patients with improved mucosa in the vonoprazan and PPI groups was 81.3% and 14.3%, respectively (p<0.001). The rate of mucosal healing was 68.8% and 7.1%, respectively (p=0.001). Conclusions: Vonoprazan significantly improved PPI-resistant RRE after esophagectomy with gastric pull-up.

2020 ◽  
Author(s):  
Jae Ho Cho ◽  
Cheol Min Shin ◽  
Hyuk Yoon ◽  
Young Soo Park ◽  
Nayoung Kim ◽  
...  

Abstract Background: The extraesophageal manifestations of gastroesophageal reflux disease (GERD) are more difficult to manage than the typical symptoms. The efficacy of high-dose and standard-dose proton pump inhibitors against these atypical symptoms is not yet established.Methods: In this single center, randomized, open-label study, patients with GERD received rabeprazole for 8 weeks, either 20 mg once daily (standard-dose group) or 20 mg twice daily (high-dose group). Patients were assessed before treatment and at weeks 4 and 8 with a 5-graded scale questionnaire consisting of 2 typical symptoms (heartburn and acid regurgitation) and 8 atypical symptoms (chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching, and dysphagia). Sufficient improvement of reflux symptoms was defined as ≥ 50% reduction from the initial questionnaire score.Results: Final analyses included 35 patients in the standard-dose group and 38 patients in the high-dose group. The rate of sufficient improvement for typical symptoms was significantly higher in the high-dose group than in the standard-dose group (100.0% vs. 84.0%, P = 0.040). For atypical symptoms, the rate of sufficient improvement tended to be higher in the high-dose group than in the standard-dose group (82.4% vs. 63.0%, P = 0.087). Scores of typical and some atypical symptoms (cough and globus) improved after treatment, with significant inter-group differences in time-course changes.Conclusions: High-dose rabeprazole is more effective for relieving typical GERD symptoms and some atypical symptoms such as cough and globus than a standard-dose regimen.Trial registration: This research was enrolled in a registry of clinical trials run by United States National Library of Medicine at the National Institutes of Health (ClinicalTrials.gov Protocol Registration and Results system ID: NCT04001400). This study was registered on June 26, 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04001400.


2020 ◽  
Author(s):  
Jae Ho Cho ◽  
Cheol Min Shin ◽  
Hyuk Yoon ◽  
Young Soo Park ◽  
Nayoung Kim ◽  
...  

Abstract Background The extraesophageal manifestations of gastroesophageal reflux disease (GERD) are more difficult to manage than the typical symptoms. The efficacy of high-dose and standard-dose proton pump inhibitors against these atypical symptoms is not yet established. Methods In this single center, randomized, open-label study, patients with GERD received rabeprazole for 8 weeks, either 20 mg once daily (standard-dose group) or 20 mg twice daily (high-dose group). Patients were assessed before treatment and at weeks 4 and 8 with a 5-graded scale questionnaire consisting of 2 typical symptoms (heartburn and acid regurgitation) and 8 atypical symptoms (chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching, and dysphagia). Sufficient improvement of reflux symptoms was defined as ≥ 50% reduction from the initial questionnaire score. Results Final analyses included 35 patients in the standard-dose group and 38 patients in the high-dose group. The rate of sufficient improvement for typical symptoms was significantly higher in the high-dose group than in the standard-dose group (100.0% vs. 84.0%, P = 0.040). For atypical symptoms, the rate of sufficient improvement tended to be higher in the high-dose group than in the standard-dose group (82.4% vs. 63.0%, P = 0.087). Scores of typical and some atypical symptoms (cough and globus) improved after treatment, with significant inter-group differences in time-course changes. Conclusions High-dose rabeprazole may be more effective for relieving atypical symptoms as well as typical GERD symptoms than a standard-dose regimen. Trial registration: This research was enrolled in a registry of clinical trials run by United States National Library of Medicine at the National Institutes of Health (ClinicalTrials.gov Protocol Registration and Results system ID: NCT04001400). This study was registered on June 26, 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04001400.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14092-e14092 ◽  
Author(s):  
Asaad Trabolsi ◽  
Megan Winter ◽  
Estelamari Rodriguez

e14092 Background: Checkpoint inhibitors (blocking antibodies to PD-1, PD-L1, CTLA-4) have proven effective against several tumor types. While the response is impressive in some patients, we still don’t understand all the patient factors that determine resistance to this class of medication. Studies of host factors have identified composition of the gut microbiome at baseline as a positive predictor of ICI response. Proton pump inhibitors have been reported to interfere with gut microbiome composition. In this single center, retrospective study, we studied the effect of concomitant treatment of proton pump inhibitors on response to ICIs in patients with locally advanced and metastatic cancer. Methods: A retrospective cohort of Non-small cell lung cancer, renal cell carcinoma and Melanoma patients that were treated from January 2016 to May 2018 at the Mount Sinai Medical Center were included in this study. Demographics, prior systemic treatment, performance status, ICI agent, and use of PPI (with in 30 days prior to 30 days after the first dose of ICI administration) were collected. Primary objective of the study was progression free survival (PFS) by utilization of PPIs. PFS was calculated using the log-rank test and survival curve was generated using the Kaplan-Meier method. Information was collected from electronic medical records. Results: Of the 97 patients that met the study criteria, 63 patients had complete data and included in the analysis. 46 patients had Non-small cell lung cancer, 13 had melanoma and 4 renal cancer. Checkpoint inhibitors most commonly prescribed included: Pembrolizumab (29 patients : 46%), Nivolumab (22 patients:35%), Nivolumab + Ipilimumab (9:14 %). 25 patients were taking PPI upon initiation of ICI treatment. In addition, 26 patients received steroids with in 30 days of treatment initiation. There was no statistically significant difference in PFS between patients on PPIs and not on PPIs. The median PFS was 672 days (95% CI: 32, 1311) for PPI users and 341 days (95% CI: 123, 558) for non PPI users. P = 0.244. Conclusions: In this, single-center, retrospective study, we did not detect a significant difference in PFS between patients who used PPI at baseline and patients who did not. Limitations of this study mainly included retrospective analysis, a small sample size, single center population and heterogeneity in disease pathology. We did not collect information on other tumor and treatment related factors like PDL 1 expression, tumor mutation burden, use of antibiotics, and immunotherapy related adverse reactions.


2021 ◽  
pp. 239719832110217
Author(s):  
Yuichiro Shirai ◽  
Noriyuki Kawami ◽  
Katsuhiko Iwakiri ◽  
Masataka Kuwana

Proton pump inhibitor-refractory reflux esophagitis is one of the intractable conditions of systemic sclerosis for which new treatments are required. Vonoprazan is a novel potassium-competitive acid blocker and has been shown to have several advantages over conventional proton pump inhibitors, including a long duration of gastric acid suppression. To investigate the efficacy of vonoprazan for treating proton pump inhibitor-refractory reflux esophagitis in patients with systemic sclerosis, 10 patients with proton pump inhibitor-refractory reflux esophagitis who were switched to vonoprazan were selected from our systemic sclerosis database. Reflux esophagitis was evaluated by endoscopy, and gastroesophageal reflux disease–related symptoms were assessed by the frequency scale for the symptoms of gastroesophageal reflux disease questionnaire before and after switching from proton pump inhibitor to vonoprazan at an average interval of 3.5 [2–5.5] months. After switching patients to vonoprazan, the endoscopic findings of reflux esophagitis were significantly improved ( p = .033), and six patients (60%) achieved mucosal healing. The total frequency scale for the symptoms of gastroesophageal reflux disease score was also significantly decreased ( p = .043), mainly by improving the acid reflux score. Vonoprazan was well tolerated and was continued for 15.5 [11.25–23.75] months in all patients. Vonoprazan is a potential treatment option for treating proton pump inhibitor-refractory reflux esophagitis in systemic sclerosis patients.


2018 ◽  
Vol 24 ◽  
pp. 249
Author(s):  
David Broome ◽  
Gauri Bhuchar ◽  
Ehsan Fayazzadeh ◽  
James Bena ◽  
Christian Nasr

Author(s):  
D. Filippiadis ◽  
C. Gkizas ◽  
G. Velonakis ◽  
Dimitrios A. Flevas ◽  
Z. T. Kokkalis ◽  
...  

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