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Introduction: We describe a case of severe hypomagnesemia that occurred during treatment with carboplatin (CBDCA) and nanoparticle albumin-bound paclitaxel (nab-PTX) for lung adenocarcinoma when co-administered with vonoprazan. Case Presentation: A man in his 70s was diagnosed with stage IIIA lung adenocarcinoma and received CBDCA and nab-PTX as the first-line treatment. The patient had been taking omeprazole 10 mg once daily (for >3 years) for gastroesophageal reflux disease, but it was switched to lansoprazole 15 mg because of hospital’s adopted medication. During the first treatment cycle, his serum creatinine levels increased from 1.0 to 1.5 mg/dL, suggesting CBDCA-associated renal impairment. Because of gastric discomfort on day 15 of the second cycle, lansoprazole was switched to vonoprazan 10 mg once daily. On day 23 of the second cycle, he developed torsades de pointes and was hospitalized; severe hypomagnesemia (0.4 mg/dL) was detected to be causing the symptoms. Discontinuation of vonoprazan and a single intravenous infusion of 60 mEq magnesium sulfate raised serum magnesium levels to 3.7 mg/dL, and the arrhythmia disappeared. Mild hypomagnesemia (1.4 mg/dL) reappeared 5 days later, and an additional intravenous infusion of 20 mEq magnesium sulfate with subsequent oral magnesium oxide (1,980 mg/day) resolved the symptoms. CBDCA was discontinued and nab-PTX monotherapy was continued. Vonoprazan was resumed owing to gastric discomfort relapse; however, grade ≥2 hypomagnesemia did not reappear later. Conclusions: This case highlights the risk of severe hypomagnesemia in patients with CBDCA and vonoprazan co-administration; therefore, regular monitoring of serum magnesium levels during the treatment is crucial. Introduction: We describe a case of severe hypomagnesemia that occurred during treatment with carboplatin (CBDCA) and nanoparticle albumin-bound paclitaxel (nab-PTX) for lung adenocarcinoma when co-administered with vonoprazan. Case Presentation: A man in his 70s was diagnosed with stage IIIA lung adenocarcinoma and received CBDCA and nab-PTX as the first-line treatment. The patient had been taking omeprazole 10 mg once daily (for >3 years) for gastroesophageal reflux disease, but it was switched to lansoprazole 15 mg because of hospital’s adopted medication. During the first treatment cycle, his serum creatinine levels increased from 1.0 to 1.5 mg/dL, suggesting CBDCA-associated renal impairment. Because of gastric discomfort on day 15 of the second cycle, lansoprazole was switched to vonoprazan 10 mg once daily. On day 23 of the second cycle, he developed torsades de pointes and was hospitalized; severe hypomagnesemia (0.4 mg/dL) was detected to be causing the symptoms. Discontinuation of vonoprazan and a single intravenous infusion of 60 mEq magnesium sulfate raised serum magnesium levels to 3.7 mg/dL, and the arrhythmia disappeared. Mild hypomagnesemia (1.4 mg/dL) reappeared 5 days later, and an additional intravenous infusion of 20 mEq magnesium sulfate with subsequent oral magnesium oxide (1,980 mg/day) resolved the symptoms. CBDCA was discontinued and nab-PTX monotherapy was continued. Vonoprazan was resumed owing to gastric discomfort relapse; however, grade ≥2 hypomagnesemia did not reappear later. Conclusions: This case highlights the risk of severe hypomagnesemia in patients with CBDCA and vonoprazan co-administration; therefore, regular monitoring of serum magnesium levels during the treatment is crucial. Introduction: We describe a case of severe hypomagnesemia that occurred during treatment with carboplatin (CBDCA) and nanoparticle albumin-bound paclitaxel (nab-PTX) for lung adenocarcinoma when co-administered with vonoprazan. Case Presentation: A man in his 70s was diagnosed with stage IIIA lung adenocarcinoma and received CBDCA and nab-PTX as the first-line treatment. The patient had been taking omeprazole 10 mg once daily (for >3 years) for gastroesophageal reflux disease, but it was switched to lansoprazole 15 mg because of hospital’s adopted medication. During the first treatment cycle, his serum creatinine levels increased from 1.0 to 1.5 mg/dL, suggesting CBDCA-associated renal impairment. Because of gastric discomfort on day 15 of the second cycle, lansoprazole was switched to vonoprazan 10 mg once daily. On day 23 of the second cycle, he developed torsades de pointes and was hospitalized; severe hypomagnesemia (0.4 mg/dL) was detected to be causing the symptoms. Discontinuation of vonoprazan and a single intravenous infusion of 60 mEq magnesium sulfate raised serum magnesium levels to 3.7 mg/dL, and the arrhythmia disappeared. Mild hypomagnesemia (1.4 mg/dL) reappeared 5 days later, and an additional intravenous infusion of 20 mEq magnesium sulfate with subsequent oral magnesium oxide (1,980 mg/day) resolved the symptoms. CBDCA was discontinued and nab-PTX monotherapy was continued. Vonoprazan was resumed owing to gastric discomfort relapse; however, grade ≥2 hypomagnesemia did not reappear later. Conclusions: This case highlights the risk of severe hypomagnesemia in patients with CBDCA and vonoprazan co-administration; therefore, regular monitoring of serum magnesium levels during the treatment is crucial. [ABSTRACT FROM AUTHOR]

Background: The efficacy of the 14-day esomeprazole–amoxicillin (EA) dual therapy in eradicating Helicobacter pylori (H. pylori) has been widely discussed previously. Vonoprazan, a novel potassium-competitive acid blocker, presents rapid, potent, and long-lasting acid inhibitory effects compared to esomeprazole. However, there is currently a scarcity of direct comparisons between the 10-day vonoprazan–amoxicillin (VA) and the 14-day EA dual therapy for H. pylori eradication. Objectives: This study aimed to compare the efficacy and safety of the 10-day VA and the 14-day EA dual therapy for H. pylori first-line eradication. Design: This study was a prospective, multicenter, open-label, randomized controlled trial. Methods: The study was conducted at 10 hospitals in China. In total, 570 newly diagnosed H. pylori -infected patients were recruited from April 2023 to February 2024. These patients were randomly assigned to either the 10-day VA group (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily) or the 14-day EA group (esomeprazole 20 mg four times daily + amoxicillin 750 mg four times daily). The primary outcome was the eradication rate, with secondary outcomes including adverse events and compliance. Results: The 10-day VA regimen outperformed the 14-day EA regimen in terms of eradication rates in intention-to-treat (ITT) analysis (85.4% vs 76.7%, p = 0.008), modified ITT analysis (90.7% vs 84.8%, p = 0.036), and per-protocol (PP) analysis (91.1% versus 85.5%, p = 0.047). The non-inferiority p -values in all three analyses were less than 0.001. No statistically significant difference was observed in the incidence of adverse events between the two groups (9.1% vs 11.7%, p = 0.308). The 10-day VA regimen demonstrated higher compliance compared to the 14-day EA regimen (p = 0.006). Conclusion: The 10-day VA dual therapy showed a satisfactory eradication rate of 91.1% (PP analysis), demonstrating good safety and better compliance compared to the 14-day EA dual therapy as the first-line eradication. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2300070475) on April 12, 2023. [ABSTRACT FROM AUTHOR]

ABSTRACT Background Aim Methods Results Conclusions Patients with erosive oesophagitis, and those with persistent symptomatic non‐erosive gastro‐oesophageal reflux disease, require long‐term maintenance treatment with acid‐suppressing agents.To evaluate the safety of vonoprazan, a potassium‐competitive acid blocker, in an integrated analysis of data from clinical trials in adults.We included 14 clinical trials of vonoprazan conducted in multiple countries. Mean duration of exposure in person‐years to vonoprazan (n = 5318) was 2068, to comparators lansoprazole (n = 1925) or esomeprazole (n = 86) was 751, and to placebo (n = 779) was 59. We report adverse events, serum gastrin, and liver enzyme levels as the main outcomes. Post‐marketing safety data from December 26, 2014 (date of commercialisation in Japan) to December 25, 2023, are also provided.Nasopharyngitis was the only adverse event reported by at least 5.0% of patients (6.94% vonoprazan, 5.07% proton pump inhibitor (PPI), 4.49% placebo). Incidence rates per 100 person‐years for serious adverse events were 10.39 for vonoprazan, 10.65 for PPIs, and 1.69 for placebo. One patient each on vonoprazan and lansoprazole was diagnosed with gastric cancer. Mean serum gastrin levels were higher on vonoprazan than lansoprazole but normalised by 4 weeks after discontinuation. Elevated liver enzyme levels were infrequent and of low magnitude with no differences between vonoprazan and PPIs. There were four deaths; none was considered related to study drug.Vonoprazan was well tolerated. Its safety profile from both clinical trial and post‐marketing data were consistent and comparable to that of its PPI comparators with respect to treatment‐emergent adverse events. [ABSTRACT FROM AUTHOR]

Background and Aim: Only a few studies have investigated the efficacy and safety of different durations of vonoprazan and amoxicillin (VA) high‐dose dual therapy for the eradication of Helicobacter pylori. We aimed to compare the efficacy and safety of 10 days versus 14 days of VA high‐dose dual therapy for H. pylori eradication. Methods: This study was conducted in 14 centers in China. A total of 250 patients infected with H. pylori were randomly assigned to Group VA‐10 or VA‐14. Both groups received the VA dual therapy (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily). The primary endpoint was the H. pylori eradication rate. Secondary endpoints included adverse events and patient compliance. Results: Group VA‐10 achieved eradication rates of 89.60%, 91.06%, and 91.67% as determined by the intention‐to‐treat (ITT), modified intention‐to‐treat (MITT), and per‐protocol (PP) analysis, respectively. The eradication rates were similar to those in Group VA‐14: 91.20%, 93.44%, and 93.39%. The difference and 90% confidence interval boundary −1.60% (−7.73% to 4.53%) in the ITT analysis, −2.39% (−8.00% to 3.23%) in the MITT analysis, and −1.72% (−7.29% to 3.85%) in the PP analysis were greater than the predefined noninferiority margin of −10%, establishing a noninferiority of Group VA‐10 versus Group VA‐14 (noninferiority P = 0.001 in ITT analysis, P < 0.001 in MITT analysis, and P < 0.001 in PP analysis, respectively). No significant differences were observed in adverse events between the two groups. Conclusions: Ten‐day VA dual therapy achieves comparable efficacy and safety to the 14‐day regimen in Chinese population, providing patients with greater convenience and economic benefits. [ABSTRACT FROM AUTHOR]

Introduction: Vonoprazan has been known to have a high Helicobacter pylori (H. pylori) eradication rate since its launch in 2015. Yet, the risk factors for eradication failure and development of post-eradication gastric cancer (GC) using VPZ regimen remain unclear. Methods: This single-center cohort study included 934 consecutive patients who underwent H. pylori eradication using VPZ between February 2015 and June 2017 and were followed up for five years by the end of 2022. We examined several indicators of systemic immune, inflammatory, and nutritional status at the time of eradication to identify those indicators could predict eradication success, risk of post-eradication GC development, and long-term prognosis. Results: The successful eradication rates were 92.6% (intention-to-treat) and 98.7% (per-protocol). Multivariate analysis showed that only a high peripheral blood neutrophil-to-lymphocyte ratio (NLR) was significantly associated with eradication failure. The 5-year GC incidence rate was 1.67%, and all GCs were stage IA. The mean (standard deviation [SD]) time from eradication to diagnosis was 40.5 (6.1) months. Multivariate analysis showed that high NLR and history of GC and hypertension were significantly associated with GC development. Patients with elevated NLR post-eradication had a higher risk of newly developed GC. Twelve patients died during the study period, and a high NLR was associated with a significantly higher mortality rate. Conclusions: NLR has the potential to be a biomarker that predicts the failure of eradication and development of post-eradication GC. High NLR was also associated with poor long-term prognosis after H. pylori eradication. [ABSTRACT FROM AUTHOR]

Helicobacter pylori is the most common chronic bacterial infection worldwide. Because of the risk for chronic gastritis, peptic ulcer disease, and gastric malignancy, all patients with H. pylori should be treated. Unfortunately, eradication rates remain low, and barriers to successful treatment include inadequate acid suppression, locoregional antibiotic resistance, and patient nonadherence to complicated treatment regimens. Vonoprazan, a new medication for the treatment of H. pylori infections, provides more potent acid suppression and is simpler to dose than proton pump inhibitors. This article provides a data-driven algorithm for incorporating vonoprazan into the treatment of patients with H. pylori infections. [ABSTRACT FROM AUTHOR]

Background: A proportion of patients with functional dyspepsia (FD) have inadequate symptom control with proton pump inhibitors (PPIs) treatment. Vonoprazan demonstrates higher efficacy in acid reduction than PPI; however, the existing efficacy data for vonoprazan in treating PPI‐refractory FD is limited. Methods: This double‐blinded, randomized controlled trial study was conducted at Rajavithi Hospital, Bangkok between December 2022 and 2023. Patients with FD who were unresponsive to the standard dose PPI were randomly assigned (1:1) to receive either 10 mg or 20 mg of vonoprazan for a 4‐week duration, with a subsequent 4‐week follow‐up after treatment. The primary outcome was changes in the Global Overall Symptoms Scale (GOSS). Results: Sixty patients were randomized without significant differences in baseline characteristics between both groups. The mean GOSS between the 10‐mg vonoprazan and the 20‐mg vonoprazan arm were 25.73 and 26.17 at week 0, 14.33 and 15.50 at week 2, 9.37 and 10.04 at week 4, and 9.79 and 9.33 at week 8, respectively (all p < 0.001 vs. baseline and p > 0.05 between groups). The quality of life was improved, with the Nepean dyspepsia index changing −4.13 and −4.25 at week 4, respectively (all p < 0.001 vs. baseline; p = 0.853 between groups). Symptom response rates (> 50% improvement in GOSS) were 72.4% and 75.9% at week 8, respectively (p = 0.24 between groups). No serious adverse events were observed. Conclusion: Vonoprazan demonstrated significant effects in the alleviation of symptoms in PPI‐refractory FD patients. There was no statistically significant difference in symptom alleviation between the 10 mg and 20 mg doses of vonoprazan. [ABSTRACT FROM AUTHOR]

Abstract Background Currently, Vonoprazan (VPZ) and amoxicillin dual regimen (VA-dual) has not achieved satisfied efficacy as the first-line treatment for Helicobacter pylori (H. pylori) infection in China. Thus, we aimed to determine the effect of VA-dual plus Saccharomyces boulardii (S. boulardii) on H. pylori eradication rate. Methods Naive H. pylori-infected patients were randomly allocated to the ECAB group [20-mg esomeprazole, 500-mg clarithromycin, 1000-mg amoxicillin, and 220-mg bismuth twice/day for 14 days] or the VAS group [20-mg VPZ twice/day, 750-mg amoxicillin three times/day, and 250-mg S. boulardii twice/day for 10 days]. Factors associated with eradication success were explored, and cost-effectiveness analyses were also performed. Results Herein, 126 patients were finally included and randomly assigned to the two groups in a 1:1 ratio. The H. pylori eradication rates of VAS and ECAB groups by intention-to-treat analysis were 87.3% and 88.9% (P = 1.000) and by per-protocol analysis were 87.3% and 91.8% (P = 0.560), respectively. The ECAB group had a significantly higher incidence of adverse events than the VAS group. Superior H. pylori eradication in the VAS group was related to small body surface area and being a non-smoker. The cost-effectiveness ratio of the VAS group was less than that of the ECAB group. Conclusions Addition of S. boulardii to VA-dual for 10 days is as effective as the 14-days bismuth-based quadruple regimen while ensuring fewer adverse events and lesser cost. This regimen is particularly suitable for low-BSA patients or non-smokers. Trial registration Chinese Clinical trial Registry No. ChiCTR2100055101 31/12/2021.

Abstract Background This umbrella review aims to synthesize evidence from previously conducted meta-analyses and review articles to assess the effects of vonoprazan-amoxicillin (VA) in the management of Helicobacter pylori (Hp). Methods While adhering to the PRIOR guidelines, PubMed, Google Scholar, Web of Science, and Scopus were searched from the database inception to May 2024 to identify relevant articles. The outcomes of interest included eradication rate, compliance, and adverse events. The risk ratios for these outcomes were compared across the studies and a corrected covered area (CCA) assessment was performed to determine overlap. Each included review was assessed for its quality and rigor via the AMSTAR-2 tool. Results From 13,743 articles identified during the literature search, 4 meta-analyses were included. A significant overlap was noted across studies with a corrected cover area of 20.8%. VA dual therapy outperformed PPI-based therapies in eradication rates (RR: 1.14–1.15, p 0.05). Compliance was significantly higher with VA dual therapy versus proton pump inhibitors (PPI)-based therapies (RR: 1.14, p = 0.004), but no significant difference was found between VA dual therapy and VAC therapy. Adverse events were reported inconsistently: one review found a higher likelihood with VA dual therapy versus PPI-based therapies (RR: 1.14, p = 0.0004), while others reported lower risk (RR: 0.59–0.80). VA dual therapy has not shown significant adverse events versus VAC therapy. Conclusion VA dual therapy presents as a promising alternative to PPI-based therapies, showcasing better eradication rates and higher compliance. Its performance is comparable to VAC triple therapy, indicating its potential as an effective treatment option for certain conditions.

Abstract Two simple, valid and green chromatographic based techniques are developed in the present work for first time to simultaneously analyze the recently approved combination of Aspirin (ASP) with the novel gastro-protective agent Vonoprazan (VON). First method is an HPLC-DAD “diode array detection”, where separation was successful using C18 (250 × 4.6 mm) column with isocratic elution of phosphate buffer-pH 6.8 and acetonitrile in ratio of 63:37 with detection at 230 nm. Second method is an HPTLC method on HPTLC silica plates using ethyl acetate: ethanol (75%): ammonia (5:5:0.05 v/v) mobile phase followed by densitometric scanning at 230 nm. The methods were applied successfully for analysis of VON and ASP mixture in laboratory-prepared tablets and the methods were validated in regards to linearity, precision, accuracy and selectivity. The proposed methods are assessed for their greenness and whiteness as well using the “Analytical GREEnness Metric Approach”, “Complementary Modified Green Analytical Procedure Index” and the new algorithm “RGB 12 model” (Red-Green-Blue) and proved the greenness and the sustainability of the methods in the routine assay of the newly marketed formulation.

Background: Currently, Vonoprazan (VPZ) and amoxicillin dual regimen (VA-dual) has not achieved satisfied efficacy as the first-line treatment for Helicobacter pylori (H. pylori) infection in China. Thus, we aimed to determine the effect of VA-dual plus Saccharomyces boulardii (S. boulardii) on H. pylori eradication rate. Methods: Naive H. pylori-infected patients were randomly allocated to the ECAB group [20-mg esomeprazole, 500-mg clarithromycin, 1000-mg amoxicillin, and 220-mg bismuth twice/day for 14 days] or the VAS group [20-mg VPZ twice/day, 750-mg amoxicillin three times/day, and 250-mg S. boulardii twice/day for 10 days]. Factors associated with eradication success were explored, and cost-effectiveness analyses were also performed. Results: Herein, 126 patients were finally included and randomly assigned to the two groups in a 1:1 ratio. The H. pylori eradication rates of VAS and ECAB groups by intention-to-treat analysis were 87.3% and 88.9% (P = 1.000) and by per-protocol analysis were 87.3% and 91.8% (P = 0.560), respectively. The ECAB group had a significantly higher incidence of adverse events than the VAS group. Superior H. pylori eradication in the VAS group was related to small body surface area and being a non-smoker. The cost-effectiveness ratio of the VAS group was less than that of the ECAB group. Conclusions: Addition of S. boulardii to VA-dual for 10 days is as effective as the 14-days bismuth-based quadruple regimen while ensuring fewer adverse events and lesser cost. This regimen is particularly suitable for low-BSA patients or non-smokers. Trial registration: Chinese Clinical trial Registry No. ChiCTR2100055101 31/12/2021. [ABSTRACT FROM AUTHOR]

Background: This umbrella review aims to synthesize evidence from previously conducted meta-analyses and review articles to assess the effects of vonoprazan-amoxicillin (VA) in the management of Helicobacter pylori (Hp). Methods: While adhering to the PRIOR guidelines, PubMed, Google Scholar, Web of Science, and Scopus were searched from the database inception to May 2024 to identify relevant articles. The outcomes of interest included eradication rate, compliance, and adverse events. The risk ratios for these outcomes were compared across the studies and a corrected covered area (CCA) assessment was performed to determine overlap. Each included review was assessed for its quality and rigor via the AMSTAR-2 tool. Results: From 13,743 articles identified during the literature search, 4 meta-analyses were included. A significant overlap was noted across studies with a corrected cover area of 20.8%. VA dual therapy outperformed PPI-based therapies in eradication rates (RR: 1.14–1.15, p < 0.05), but showed no significant difference compared to vonoprazan-amoxicillin-clarithromycin (VAC) triple therapy (RR: 0.95–0.97, p > 0.05). Compliance was significantly higher with VA dual therapy versus proton pump inhibitors (PPI)-based therapies (RR: 1.14, p = 0.004), but no significant difference was found between VA dual therapy and VAC therapy. Adverse events were reported inconsistently: one review found a higher likelihood with VA dual therapy versus PPI-based therapies (RR: 1.14, p = 0.0004), while others reported lower risk (RR: 0.59–0.80). VA dual therapy has not shown significant adverse events versus VAC therapy. Conclusion: VA dual therapy presents as a promising alternative to PPI-based therapies, showcasing better eradication rates and higher compliance. Its performance is comparable to VAC triple therapy, indicating its potential as an effective treatment option for certain conditions. [ABSTRACT FROM AUTHOR]

Background: Current eradication regimens are not ideal for Helicobacter pylori infected patients who have difficulty choosing antibiotics due to penicillin allergy or antibiotic resistance. Objective: To explore the efficacy and safety of a simple vonoprazan-minocycline dual therapy (VM dual therapy) in H. pylori eradication. Design: Clinical data of patients who were prescribed 14-day VM dual therapy were retrospectively collected. The included patients were 18–70 years old and positive for 13C urea breath test (13C-UBT). They were allergic to penicillin or had a history of repeated antibiotic exposure or had failed eradication with multiple regimens containing amoxicillin. VM dual therapy consists of vonoprazan 20 mg twice daily and minocycline 100 mg twice daily. 13C-UBT was repeated 4–6 weeks after treatment to evaluate the therapeutic outcome. Results: Of the 88 enrolled patients, 54 were treatment naïve, 13 had one prior eradication failure, and 21 had multiple eradication failures. The overall intention to treat (ITT) and per-protocol (PP) eradication rates were 90.9% (95% CI: 82.4–95.7) and 95.2% (95% CI: 87.6–98.5). The ITT eradication rates were 90.7% (95% CI: 78.9–96.5) in treatment-naïve patients, 84.6% (95% CI: 53.7–97.3) in patients with one prior treatment failure, and 95.2% (95% CI: 74.1–99.8) in patients with multiple failures. The PP eradication rates were 94.2% (95% CI: 83.1–98.5), 91.7% (95% CI: 59.8–99.6), and 100%, respectively. The overall incidence of adverse events was 23.0%. The common adverse reactions were nausea and mild dizziness, which could be resolved without intervention. Conclusion: Simple VM dual therapy exhibited a good eradication rate, low incidence of adverse effects, and good adherence. It is a potential new regimen for both first-line and rescue therapy. Plain language summary: The simple 14-day vonoprazan-minocycline dual therapy is a promising new regimen for Helicobacter pylori eradication Current eradication regimens are not ideal for Helicobacter pylori infected patients who have difficulty choosing antibiotics due to penicillin allergy or antibiotic resistance. We explored a simple vonoprazan-minocycline dual therapy for these patients. We retrospectively collected 88 Helicobacter pylori infected patients' clinical data. They were allergic to penicillin or had a history of repeated antibiotic exposure, or had failed eradication with multiple regimens containing amoxicillin. VM dual therapy consists of Vonoprazan 20mg twice daily and minocycline 100mg twice daily. In the 54 treatment naïve patients, the eradication rate was 90.7%. In the 13 patients with on prior failure and the 21 patients with multiple failures, the eradication rates was 84.6% and 95.2%. 23% of the patients reported adverse events, which was mailnly nausea and mild dizziness. Our study suggested that the simple VM dual therapy exhibited a good eradication rate, low incidence of adverse effects, and good adherence. It is a promising new regimen. [ABSTRACT FROM AUTHOR]

Two simple, valid and green chromatographic based techniques are developed in the present work for first time to simultaneously analyze the recently approved combination of Aspirin (ASP) with the novel gastro-protective agent Vonoprazan (VON). First method is an HPLC-DAD "diode array detection", where separation was successful using C18 (250 × 4.6 mm) column with isocratic elution of phosphate buffer-pH 6.8 and acetonitrile in ratio of 63:37 with detection at 230 nm. Second method is an HPTLC method on HPTLC silica plates using ethyl acetate: ethanol (75%): ammonia (5:5:0.05 v/v) mobile phase followed by densitometric scanning at 230 nm. The methods were applied successfully for analysis of VON and ASP mixture in laboratory-prepared tablets and the methods were validated in regards to linearity, precision, accuracy and selectivity. The proposed methods are assessed for their greenness and whiteness as well using the "Analytical GREEnness Metric Approach", "Complementary Modified Green Analytical Procedure Index" and the new algorithm "RGB 12 model" (Red-Green-Blue) and proved the greenness and the sustainability of the methods in the routine assay of the newly marketed formulation. [ABSTRACT FROM AUTHOR]

Background and Aim: Helicobacter pylori infection is linked to various gastrointestinal conditions, such as chronic active gastritis, peptic ulcers, and gastric cancer. Traditional treatment options encounter difficulties due to antibiotic resistance and adverse effects. Therefore, the aim of this study was to explore the effectiveness of a new treatment plan that combines vonoprazan (VPZ), amoxicillin, and bismuth for the eradication of H. pylori. Methods: A total of 600 patients infected with H. pylori were recruited for this multicenter randomized controlled trial. Patients treated for H. pylori elimination were randomly assigned at a 1:1 ratio to receive 14 days of vonoprazan‐based triple therapy (vonoprazan + amoxicillin + bismuth, group A) or standard quadruple therapy (esomeprazole + clarithromycin + amoxicillin + bismuth, group B). Compliance and adverse effects were tracked through daily medication and side effect records. All patients underwent a 13C/14C‐urea breath test 4 weeks after treatment completion. Results: Intention‐to‐treat (ITT) and per‐protocol (PP) analyses revealed no substantial differences in H. pylori eradication rates between groups A and B (ITT: 83.7% vs 83.2%; PP: 90.9% vs 89.7%). However, significant differences were observed in the assessment of side effects (13.7% vs 28.6%, P < 0.001). Specifically, group A had significantly fewer "bitter mouths" than group B did (3.7% vs 16.2%, P < 0.001). Conclusion: Triple therapy comprising vonoprazan (20 mg), amoxicillin (750 mg), and bismuth potassium citrate (220 mg) achieved a PP eradication rate ≥90%, paralleling standard quadruple therapy, and had fewer adverse events and lower costs (¥306.8 vs ¥645.8) for treatment‐naive patients. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To probe into the the prognosis and efficacy of vonoprazan combined with Zhizhu Kuanzhong capsule in the treatment of patients with gastroesophageal reflux disease ( GERD) and its effects on expression levels of heme oxygenase-1 (HO-1) and glutathione (GSH). METHODS: Totally 120 patients with GERD admitted into the hospital from May 1st, 2022 to May 1st, 2023 were extracted to be divided into two groups by digital lottery grouping method. The control group (n = 60) and study group ( n = 60) respectively received vonoprazan and vonoprazan combined with Zhizhu Kuanzhong capsule. The efficacy, expression levels of HO-1 and GSH, gastroesophageal reflux disease questionnaire ( GERDQ ) score, inflammatory factors [ tumor necrosis factor-α (TNF-α), interleukin (IL)-1β, IL-6] levels and incidence of adverse drug reactions of two groups were compared. RESULTS: The effective rate of the study group was 96. 67% (58 / 60), higher than 81. 67% (49 / 60) of the control group, the difference was statistically significant ( P < 0. 05). There was no significant difference in serum indexes (HO-1, GSH), symptom score ( GERDQ) and inflammatory factors ( TNF-α, IL-1β, IL-6) between two groups before treatment (P>0. 05). After treatment, HO-1 in the study group was lower than that in the control group, GSH was higher than that in the control group, GERDQ score was lower than that in the control group, the levels of TNF-α, IL-1β and IL-6 were lower than those in the control group, the differences were statistically significant (P<0. 05). The incidence of adverse drug reactions in the study group and the control group was respectively 5. 00% (3 / 60) and 6. 67% (4 / 60), with no statistically significant difference ( P > 0. 05). CONCLUSIONS: The clinical efficacy of vonoprazan combined with Zhizhu Kuanzhong capsule in the treatment of GERD is better, and the laboratory indicators and clinical symptoms of GERD can be significantly improved with higher safety. [ABSTRACT FROM AUTHOR]

Background: Helicobacter pylori (H. pylori), prevalent in developing regions, is a key factor in gastrointestinal diseases. Despite the common use of bismuth-based quadruple therapy, its drawbacks have prompted the search for alternatives. Recently, vonoprazan, a novel acid suppressant, has shown promise in combination with antibiotics as a dual therapy for H. pylori eradication. This study aimed to assess the therapeutic outcomes and adverse events of vonoprazan-amoxicillin dual therapy compared to quadruple therapy. Methods: A randomized controlled trial (RCT) enrolled H. pylori-infected patients at Zhejiang Hospital. Participants were randomly assigned to dual and quadruple therapy groups. The primary endpoints were H. pylori eradication and adverse events. Results: Of the 400 patients studied from April 2022 to June 2023, In the intention-to-treat (ITT) analysis, the eradication rates of H. pylori in vonoprazan-amoxicillin dual therapy group and quadruple therapy group were 94.0% and 87.0%, respectively, p = 0.017. In the per-protocol (PP) analysis were 97.9% and 93.0%, p = 0.022. Additionally, the dual therapy group had a significantly lower incidence of adverse events (19%) compared to the quadruple therapy group (53%) (p < 0.001). Conclusion: Vonoprazan-amoxicillin dual therapy demonstrates superior eradication efficacy and reduced adverse events compared to quadruple therapy in H. pylori-infected patients, suggesting its potential for clinical application and promotion. [ABSTRACT FROM AUTHOR]

Background: The efficacy of Helicobacter pylori (H. pylori) eradication therapies encompassing one or more antibiotics and a proton pump inhibitor (PPI) has lately decreased. Vonoprazan (VPZ), a potassium‐competitive acid blocker, provides higher gastric acid suppression than PPIs. We performed a meta‐analysis evaluating the efficacy and safety of VPZ in H. pylori eradication therapies. Methods: Studies were searched in PubMed, Embase, and the Cochrane Library up to June 2023. Efficacy was evaluated by intention‐to‐treat analysis. Data were combined by meta‐analyzing risk differences (RD). Heterogeneity was evaluated by subgrouping. Results: Seventy‐seven studies (24 randomized clinical trials) evaluated 44,162 patients (22,297 receiving VPZ and 21,865 PPIs). Overall VPZ efficacy was 88% (95% CI = 87%–90%): 86%, 88%, and 94% for dual/triple/quadruple‐VPZ‐containing therapies. VPZ efficacy was 87% (86%–89%) in first‐line and 90% (87%–93%) in rescue therapy. VPZ performed better than PPIs in treatment‐naïve patients (87% vs. 70%; RD = 0.13, 95% CI = 0.11–0.15) and when using triple regimens. No significant differences were observed in rescue and quadruple therapies. In patients with clarithromycin‐resistant infection, VPZ‐based therapies demonstrated an 81% efficacy (76%–85%), surpassing PPIs (76% vs. 40%; RD = 0.33, 95% CI = 0.24–0.43). For clarithromycin‐susceptible strains, VPZ efficacy was 92% (89%–95%), similar to PPIs. VPZ adverse events rate was 19% (16%–21%), comparable to PPI‐based regimens (18% vs. 13%, respectively; RD = 0.00, 95% CI = −0.01 to 0.02, p = 0.57). Conclusions: The efficacy of VPZ‐based regimens was over 85% in all treatment combinations. In treatment‐naïve and clarithromycin‐resistant patients, VPZ performed better than PPIs. In rescue therapy, in clarithromycin‐susceptible patients or when quadruple regimens were prescribed, this advantage was not confirmed. Tolerability was similar in both regimens. [ABSTRACT FROM AUTHOR]

The article discusses the efficacy of vonoprazan-based dual and triple therapy compared to lansoprazole-based triple therapy in treating Helicobacter pylori infection. The study found that vonoprazan-based therapies were generally consistent in effectiveness across various patient characteristics such as age, sex, race, and compliance with the study drug. Factors like clarithromycin resistance, age, compliance, and alcohol use were found to influence eradication rates. Overall, the study concluded that vonoprazan-based regimens were effective regardless of patient demographics and behaviors. [Extracted from the article]

Purpose of the Review: Acid suppression with proton pump inhibitors (PPIs) represents the standard of care in the treatment of acid-related diseases. However, despite their effectiveness, PPIs display some intrinsic limitations, which underlie the unmet clinical needs that have been identified over the past decades. The aims of this review are to summarize the current status and future development of the new class of antisecretory drugs (potassium-competitive acid blockers, P-CABs) that have recently been introduced into medical practice. Recent Findings: Over the past decades, clinical needs unmet by the current acid suppressants have been recognized, especially in the management of patients with GERD, Helicobacter pylori infection and NSAID-related peptic ulcer. The failure to address these needs is mainly due to their inability to achieve a consistent acid suppression in all patients and, particularly, to control nighttime acidity. It was then realized that an extended duration of acid suppression would exert additional benefits. The available data with P-CABs show that they are able to address these unmet clinical needs. Summary: Four different P-CABs (vonoprazan, tegoprazan, fexuprazan and keverprazan) are currently available. However, only two of them are approved outside Asia. Vonoprazan is available in North, Central and South America while tegoprazan is marketed only in Latin American countries. Two other compounds (namely linazapran glurate and zestaprazan) are presently under clinical development. While clinical trials on GERD have been performed with all P-CABs, only vonoprazan and tegoprazan have been investigated as components of Helicobacter pylori eradication regimens. The available data show that—in the above two clinical indications—P-CABs provide similar or better efficacy in comparison with PPIs. Their safety in the short-term overlaps that of PPIs, but data from long-term treatment are needed. [ABSTRACT FROM AUTHOR]

Introduction: Although Vonoprazan, a potassium-competitive acid blocker, is superior to proton pump inhibitors (PPIs) in treating Helicobacter pylori and erosive esophagitis, its efficacy for treating gastric and/or duodenal ulcers remains controversial. This meta-analysis summarizes the efficacy and safety of Vonoprazan vs. PPI for treating and preventing gastric and/or duodenal ulcers. Methods: Only randomized controlled trials randomizing gastric and/or duodenal ulcer patients, regardless of etiology, into Vonoprazan or any PPI and indexed in Embase, Medline, and CENTRAL until March 2, 2024 were searched. Primary outcomes were ulcer healing rates at Weeks 2, 4, 6, and 8 and recurrence rates at Week 24. Other outcomes included shrinkage rates, any adverse events (AEs), serious AEs (SAEs), and risks of delayed bleeding and perforation. The overall risk ratio (RR) and mean difference were pooled using the random-effects model. The risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB2) Tool. Results: Fifteen studies comprising 43 reports were included in the analysis. Healing rates of gastric and/or duodenal ulcers were similar in both Vonoprazan and PPI groups at all weeks (Week 2 RR 1.02 [95% CI 0.89–1.16]; Week 4 0.99 [95% CI 0.95–1.04]; Week 6 1.00 [95% CI 0.96–1.03]; Week 8 0.99 [95% CI 0.95–1.03]). The recurrence prevention of peptic ulcers was not different in Vonoprazan 10 mg (RR 0.48; 95% CI 0.18–1.27) or 20 mg (0.60; 95% CI 0.28–1.30) to PPI. Shrinkage rates, any AEs, SAEs, and risks of delayed bleeding and perforation were similar in both groups. Conclusion: Vonoprazan is not significantly better than PPI in treating and preventing gastric and/or duodenal ulcers. [ABSTRACT FROM AUTHOR]

Non-Helicobacter pylori Helicobacter (NHPH) species are emerging as significant gastric pathogens. Despite their clinical importance, NHPH infections are less studied compared to Helicobacter pylori (H. pylori) due to their lower prevalence and diagnostic challenges. Zoonotic transmission, particularly from pigs, dogs, and cats, underscores the need for improved diagnostic methods and heightened clinical awareness. Gastric cancer (GC) remains a major global health issue, with H. pylori being a primary risk factor. The eradication of H. pylori reduces GC risk, but post-eradication surveillance is essential. Endoscopic findings, especially those from the Kyoto classification, and noninvasive biomarkers play crucial roles in early GC detection and risk assessment. The increasing antibiotic resistance in H. pylori necessitates new treatment strategies. Novel therapies, such as vonoprazan-based regimens, and alternatives like sitafloxacin and rifabutin, are being developed to improve eradication success rates. Understanding the fundamental mechanisms of gastric carcinogenesis, including the roles of oxidative stress and cancer stem cells, is key to advancing treatment. Targeting specific molecular pathways offers potential for more effective therapies. [ABSTRACT FROM AUTHOR]

Background: Helicobacter pylori (H. pylori) infection is a global health concern, affecting approximately two-thirds of the world's population. Standard first-line treatment regimens often fail, necessitating alternative rescue therapies. Objectives: This review aims to evaluate the efficacy and safety of newer treatment regimens in patients who have failed initial H. pylori eradication therapy. Methods: A comprehensive literature search was conducted in PubMed, the Cochrane Library, and Embase. Inclusion criteria were randomized controlled trials (RCTs) published after 2010, involving patients with previous H. pylori treatment failure and interventions with vonoprazan-based therapy, high-dose PPI–amoxicillin dual therapy (HDDT), or rifabutin-containing triple therapy. Results: 10 RCTs were included. HDDT demonstrated high eradication rates (81.3% to 89.2%), particularly when combined with metronidazole (92.6%), although at an increased frequency of adverse events. Vonoprazan-based regimens achieved comparable or higher eradication rates (83.3% to 89.5%) compared to PPI-based therapies, with similar adverse events. Rifabutin-containing triple therapy showed high efficacy (80.7% to 100%), particularly in patients with a history of multiple treatment failures, and it was associated with lower adverse events compared to bismuth-containing regimens. Conclusions: HDDT, vonoprazan-based therapy, and rifabutin-based therapy have proven to be effective and safe rescue regimens for treating H. pylori infection. Additional large-scale randomized studies are needed to determine the optimal doses and durations of these regimens to achieve the highest eradication rate with the lowest incidence of adverse events among patients with refractory H. pylori infections globally. [ABSTRACT FROM AUTHOR]

This is the first registered intervention study for vonoprazan, high-dose amoxicillin, clarithromycin, and metronidazole 14-day concomitant therapy based on a susceptibility test of Helicobacter pylori. We conducted this study as a fourth-line rescue regimen in Japan. Methods: Twenty patients who underwent three rounds of eradication therapies (first- or second-line 7-day triple therapy consisting of amoxicillin and clarithromycin, or metronidazole- and sitafloxacin-based third-line therapy) and had failed eradication based on a urea breath test or fecal antigen test were recruited. All patients underwent endoscopic examination and culture tests before starting eradication therapy. The intervention was concomitant therapy consisting of vonoprazan 20 mg bid, amoxicillin 500 mg qid, clarithromycin 400 mg bid, and metronidazole 250 mg bid for 14 days, which were modified based on the susceptibility test, and the resistant drugs were removed from the regimen. Patients with negative culture results were treated with quadruple therapy. The primary outcome was the eradication rate (UMIN000025765, jRCTs 031180208). Results: The eradication rate of susceptibility-testing-based fourth-line eradication therapy was 63.2% (95%CI: 38.4–83.7%) in intent-to-treat analysis and 70.6% (95%CI: 44.0–89.7%) in per-protocol analysis. Thirteen patients received quadruple therapy, with eradication rates of 61.5% and 75.0%, respectively. No serious adverse events were reported. Conclusions: This vonoprazan-based concomitant therapy modified by the susceptibility test is a potential option as fourth-line eradication after first-line clarithromycin-based 7-day triple, second-line metronidazole-based 7-day triple, and third-line sitafloxacin-based 7-day triple therapy failure. [ABSTRACT FROM AUTHOR]

Abstract\nHIGHLIGHTSThe effectiveness of vonoprazan (VPZ)-based regimens in enhancing Helicobacter pylori (HP) eradication rates is promising. This study evaluated the clinical efficacy of 14-day VPZ-based triple therapy in obese patients infected with HP. A total of 200 obese patients with gastric disorders, confirmed to be HP-positive via gastroscopy and the 13C urea breath test, were retrospectively analyzed. Among them, 118 patients received the 14-day VPZ-based triple regimen (Study group), while 82 patients were treated with the traditional 14-day bismuth-containing proton pump inhibitor-based quadruple regimen (Control group). Baseline characteristics, pretreatment inflammatory indicators, lipid profiles, and gastrointestinal function indicators recorded. The two groups were compared for treatment efficacy, HP eradication rate, gastrointestinal function improvement, and incidence of adverse reactions. The Study group demonstrated a higher overall effective rate compared to the Control group, particularly in HP-strong positive obese patients. No significant differences were observed between the two groups for HP-positive obese patients in terms of total effective rate, HP eradication rate, gastrointestinal function improvement, or adverse reactions incidence. In conclusion, the 14-day VPZ-based triple regimen exhibited superior therapeutic efficacy, higher HP eradication rates, enhanced gastrointestinal function, and reduced adverse reactions in HP-strong positive obese patients, indicating improved overall efficacy and safety.The 14-d VPZ-based triple regimen is effective in HP-infected obese patients.The 14-d VPZ-based triple regimen has a high total effective rate in HP-strong positive-infected obese patients.The 14-d VPZ-based triple regimen has a high HP eradication rate in HP-strong positive-infected obese patients.The 14-d VPZ-based triple regimen has good improvement on the gastrointestinal function of HP-strong positive-infected patients.The 14-d VPZ-based triple regimen has low adverse reaction incidence in HP-strong positive-infected obese patients. [ABSTRACT FROM AUTHOR]

Background: We compared efficacy of vonoprazan‐dual or triple therapies and bismuth‐quadruple therapy for treatment‐naive Helicobacter pylori (HP) infection in Southern China, where primary resistance rates of clarithromycin and levofloxacin are >30%. Methods: This was an investigator‐initiated, three‐arm, randomized clinical trial in Southern China. Between March 2022 and August 2023, treatment‐naïve HP‐infected adults were randomly assigned to receive one of three 14‐day regimens (1:1:1 ratio): vonoprazan‐dual (VA‐dual; vonoprazan 20 mg twice daily and amoxicillin 1 g thrice daily), vonoprazan‐triple (VAC‐triple; vonoprazan 20 mg/amoxicillin 1 g/clarithromycin 500 mg twice daily), or bismuth‐quadruple therapy containing bismuth, esomeprazole, tetracycline, and metronidazole. Primary outcome was noninferiority in HP eradication, evaluated by UBT 4–6 weeks post‐treatment by intention‐to‐treat (ITT) and per‐protocol (PP) analysis (based on subjects who completed 14‐day treatment and rechecked UBT). Bonferroni‐adjusted p‐value of <0.017 was used to determine statistical significance. Results: A total of 298 subjects (mean age: 35.7 ± 8.4 years; male: 134 [45.0%]; VC‐dual: 100, VAC‐triple: 98, bismuth‐quadruple: 100) were enrolled, and 292 (98.0%) had UBT rechecked. ITT analysis showed that both VA‐dual (eradication rate of 96.0%) and VAC‐triple therapies (95.9%) were noninferior to bismuth‐quadruple therapy (92.0%) (difference: 4.0%, 95% CI: −2.9% to 11.5%, p < 0.001; and 3.9%, 95% CI: −3.1% to 11.5%, p < 0.001, respectively). PP analysis also revealed noninferiority (96.7% or 96.7% vs. 97.4%, with difference: −2.9% and −2.9%, p = 0.009 and 0.010, respectively). The frequency of adverse events was 39.0%, 56.1%, and 71.0% in VA‐dual, VAC‐triple, and bismuth‐quadruple therapies, respectively. Conclusions: VA‐dual and VA‐triple therapies are highly effective and noninferior to bismuth‐quadruple therapy in Southern China. Given the lower adverse effects and fewer antibiotic use, VA‐dual therapy is the preferred first‐line treatment for HP infection. Trial Registration: Chinese Clinical Trial Registry (No. ChiCTR2200056375). Registered on February 4, 2022, https://www.chictr.org.cn/showproj.aspx?proj=14131. [ABSTRACT FROM AUTHOR]

ABSTRACT Background A proportion of patients with functional dyspepsia (FD) have inadequate symptom control with proton pump inhibitors (PPIs) treatment. Vonoprazan demonstrates higher efficacy in acid reduction than PPI; however, the existing efficacy data for vonoprazan in treating PPI‐refractory FD is limited. Methods This double‐blinded, randomized controlled trial study was conducted at Rajavithi Hospital, Bangkok between December 2022 and 2023. Patients with FD who were unresponsive to the standard dose PPI were randomly assigned (1:1) to receive either 10 mg or 20 mg of vonoprazan for a 4‐week duration, with a subsequent 4‐week follow‐up after treatment. The primary outcome was changes in the Global Overall Symptoms Scale (GOSS). Results Sixty patients were randomized without significant differences in baseline characteristics between both groups. The mean GOSS between the 10‐mg vonoprazan and the 20‐mg vonoprazan arm were 25.73 and 26.17 at week 0, 14.33 and 15.50 at week 2, 9.37 and 10.04 at week 4, and 9.79 and 9.33 at week 8, respectively (all p 0.05 between groups). The quality of life was improved, with the Nepean dyspepsia index changing −4.13 and −4.25 at week 4, respectively (all p 50% improvement in GOSS) were 72.4% and 75.9% at week 8, respectively (p = 0.24 between groups). No serious adverse events were observed. Conclusion Vonoprazan demonstrated significant effects in the alleviation of symptoms in PPI‐refractory FD patients. There was no statistically significant difference in symptom alleviation between the 10 mg and 20 mg doses of vonoprazan.

Since the introduction of vonoprazan, a potassium-competitive acid blocker (P-CAB), it has been demonstrated to reversibly inhibit gastric acid secretion by engaging in potassium-competitive ionic binding to H+/K+-ATPase. In contrast, proton pump inhibitors (PPIs) achieve H+/K+-ATPase inhibition through covalent binding to cysteine residues of the proton pump. Reported cases have indicated an emerging trend of P-CAB-related gastropathies, similar to those associated with PPIs, as well as unique gastropathies specific to P-CAB use, such as the identification of web-like mucus. Pathologically, parietal cell profusions, which show a positively correlated with hypergastrinemia, have a higher incidence in P-CAB users compared to PPI users. Thus, this review aims to summarize the endoscopic and pathological findings reported to date concerning P-CAB-related gastric mucosal lesions. Additionally, it seeks to discuss the differences between the PPIs and P-CABs in terms of the formation and frequency of associated gastropathies. This review highlights the evident differences in the mechanism of action and potency of acid inhibition between P-CABs and PPIs, notably contributing to differences in the formation and frequency of associated gastropathies. It emphasizes the necessity to distinguish between P-CAB-related and PPI-related gastropathies in the clinical setting.

Abstract A new, sensitive, and rapid isocratic reversed phase chromatographic method (RP-HPLC–UV) was developed for simultaneous separation of two newly co-formulated antiulcer mixtures; Amoxicillin, Vonoprazan and Clarithromycin [Mixture (I)], and Amoxicillin, Lansoprazole and Clarithromycin [Mixture (II)]. Analytical separation was performed using a Promosil C18 column and ultraviolet detection at 210 nm. The separation was achieved within only 8 min. For both mixtures, an aqueous solution, composed of (Acetonitrile: Methanol: 0. 2 M phosphoric acid) within ratio of (30: 30: 40) adjusted to final pH 3.0, was the mobile phase. This method was validated as per the International Conference on Harmonization guidelines. The linearity ranges of these proposed method of the (Mixture (I)) were 25.0–400.0 µg/mL Amoxicillin, 0.5–8.0 µg/mL Vonoprazan, and 12.5–200.0 µg/mL Clarithromycin. And the linearity ranges of the (Mixture (II)) were 10.0–300.0 µg/mL Amoxicillin, 0.3–9.0 µg/mL Lansoprazole and 5.0–150.0 µg/mL Clarithromycin. This method was firstly applied for effective separation of Amoxicillin, Vonoprazan and Clarithromycin [Mixture (I)]. It fulfilled good repeatability, sensitivity, and accuracy (R.S.D.

Abstract Background In Chinese healthcare settings, drug selection decisions are predominantly influenced by the Pharmacy & Therapeutics Committee (PTC). This study evaluates two recently introduced potassium-competitive acid blockers, vonoprazan (VPZ) and tegoprazan (TPZ), utilizing the Evidence and Value: Impact on DEcisionMaking (EVIDEM) framework. Methods The study employed the 10th edition of EVIDEM, which includes a core model with five domains and 13 criteria. Two independent expert panels were involved: the PTC expert panel, tasked with assigning weights using a 5-point scale, defining scoring indicators, examining the evidence matrix, scoring, and decision-making; and the evidence matrix expert panel, responsible for conducting a systematic literature review, creating the evidence matrix, and evaluating the value contributions of VPZ and TPZ. Results The analysis estimated the value contributions of VPZ and TPZ to be 0.59 and 0.54, respectively. The domain of ‘economic consequences of intervention’ showed the most significant variation in value contribution between the two drugs, followed by ‘comparative outcomes of intervention’ and ‘type of benefit of intervention’. Conclusion Employing the EVIDEM framework, VPZ’s value contribution was found to be marginally superior to that of TPZ. The EVIDEM framework demonstrates potential for broader application in Chinese medical institutions.

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Gastroesophageal reflux disease (GERD) symptoms frequently recur after cessation of acid blockers. The presence of a hiatal hernia may worsen GERD symptoms and increase the risk of esophageal malignancy. The aim of this study is to clarify the timing and predictors for recurrence of GERD symptoms after cessation of vonoprazan (VPZ) therapy. A retrospective observational study involved 86 patients who underwent cessation of VPZ therapy for symptomatic GERD. Collated data from medical record review included the endoscopic findings and Izumo scale score. The mean duration of continuous VPZ therapy before cessation was 7.9 months. GERD symptoms requiring the resumption of VPZ therapy recurred in 66 of 86 patients (77%). Kaplan-Meier analysis showed that overall recurrence-free rates at 6 months, one and two years after VPZ cessation were 44%, 32% and 23%, respectively. Alcohol use, the presence of a hiatal hernia and long-term therapy for more than six months were identified as significant positive predictors for symptomatic recurrence. Notably, hiatal hernia had the highest hazard ratio in both univariate and multivariate analyses. The recurrence-free rate in patients with a hiatal hernia was much lower at 6 months than in patients without a hiatal hernia (15% and 51%, respectively p = 0.002). After the symptomatic recurrence, GERD symptoms improved significantly after one-month VPZ therapy. The rate of symptomatic recurrence after VPZ cessation in patients with GERD is considerable. Cessation of acid suppression therapy should be cautious in patients with both a hiatal hernia and GERD. [ABSTRACT FROM AUTHOR]

Vonoprazan (VPZ) has been available in Japan since 2015. Endoscopic features of proton-pump inhibitor (PPI)-related gastric mucosal changes, including fundic gland and hyperplastic polyps, have been observed. However, the relationship between gastric polyps and VPZ remains unclear. A 65-year-old man with reflux esophagitis-associated symptoms refractory to PPI was referred to our hospital. VPZ (20 mg) was administered for 3 weeks, which proved effective. Afterward, VPZ dose was reduced to 10 mg; the reflux symptoms worsened, and 20 mg VPZ was restarted. Afterward, esophagogastroduodenoscopy (EGD) revealed a gradually enlarging gastric polyp in the cardia. After 5 years of VPZ administration, the patient developed a reddish polyp (approximately 10 mm) with a whitish substance in the cardia. Based on the clinical course, the polyp was considered to have enlarged because of the long-term VPZ administration. After being informed of the endoscopic findings, the patient decided to discontinue VPZ. One year after VPZ discontinuation, EGD revealed a shrunken polyp (5 mm). Long-term acid suppression causes hypergastrinemia, which may lead to gastric mucosal changes, including gastric polyps. There are few case reports of a decrease in the number and size of gastric polyps after VPZ discontinuation. Hence, some VPZ-induced endoscopic changes may be reversible. [ABSTRACT FROM AUTHOR]

Background: In the absence of Helicobacter pylori (HP) infection, a characteristic gastric mucus adhesion may appear during the use of vonoprazan. We named this novel characteristic mucus "web-like mucus" (WLM). This study aimed to determine the incidence and risk factors for WLM. Methods: Between January 2017 and January 2022, 5665 patients were enrolled in this study. The patients were divided into a proton-pump inhibitor (PPI)-prescribed group (n = 2000), a vonoprazan-prescribed group (n = 268), and a no-PPI/vonoprazan-prescribed (n = 3397) group, and the presence of WLM was examined. After excluding four patients with autoimmune gastritis, the remaining 264 patients in the vonoprazan group were divided into WLM and non-WLM groups, and their clinical features were analyzed. Results: A total of 55 (21%) patients had WLM, all in the vonoprazan-prescribed group. There were no significant differences in factors such as, sex, age, chronic kidney disease, diabetes mellitus, HP eradication history, smoking, or alcohol consumption between the WLM and non-WLM groups. The median duration from the start of vonoprazan administration to the endoscopic detection of WLM was 2 (1–24) months. Conclusions: WLM appears to be a characteristic feature in patients treated with vonoprazan. [ABSTRACT FROM AUTHOR]

Background: The situation of Helicobacter pylori eradication therapy has been changing over time, owing to increases in antimicrobial‐resistant strains, lifestyle improvements, and changes in indications for eradication. In Japan, eradication therapy is now available to all H. pylori‐positive patients under the medical insurance system, and the potassium‐competitive acid blocker vonoprazan has been used for eradication from 2015. Recently, with the aging of society, opportunities to provide eradication to elderly patients are increasing, but the current status and effectiveness of eradication in elderly patients remains unclear. Therefore, we aimed to investigate the trends of H. pylori eradication in a metropolitan area to determine the factors associated with successful H. pylori eradication in elderly patients older than 80 years. Methods: Trends in the eradication rates of patients who received first‐ or second‐line eradication at 20 hospitals in the Tokyo metropolitan area from 2013 to 2023 were investigated. Results: The eradication rates in the per‐protocol analysis were 82.3% (95% confidence interval [CI]: 81.2%–83.2%) for the first‐line treatment (n = 6481), and 87.9% (86.9%–88.9%) for the second‐line treatment (n = 4899). Multivariate analysis showed that independent factors for successful eradication in the first‐line treatment were an age of older than 80 years (OR: 0.606; 95% CI: 0.448–0.822), peptic ulcers (vs. atrophic gastritis: 3.817; 3.286–4.433), and vonoprazan (vs. proton pump inhibiters (PPIs), 3.817; 3.286–4.433), and an age of older than 80 years (0.503; 0.362–0.699) and vonoprazan (1.386; 1.153–1.667) in the second‐line treatment. Conclusion: After 2015, the eradication rate of both first‐ and second‐line therapies were maintained at a higher level than before 2015, owing to the use of vonoprazan. As the H. pylori eradication rate in patients older than 80 years was low, an effective strategy for these patients needs to be developed in the future. [ABSTRACT FROM AUTHOR]

Background: The effect of preprandial or postprandial administration of amoxicillin on the efficacy of vonoprazan–amoxicillin dual therapy (VA‐dual therapy) for Helicobacter pylori treatment has not been studied. It is also unclear whether amoxicillin dosing four times daily is more effective than three times daily. We aimed to investigate the effect of different amoxicillin administration regimens on the efficacy of VA‐dual therapy. Materials and Methods: H. pylori‐infected subjects were randomly assigned to three groups in a 1:1:1 ratio to receive a 14‐day dual therapy consisting of vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily before meals (BM‐TID) or 1000 mg three times daily after meals (AM‐TID) or 750 mg four times daily after meals (AM‐QID). H. pylori eradication rates, adverse events rates, compliance, and antibiotic resistance were compared. Results: Between May 2021 to April 2023, 327 subjects were enrolled. The eradication rates of BM‐TID, AM‐TID, and AM‐QID dual therapy were 88.1%, 89.9%, and 93.6% in intention‐to‐treat (ITT) analysis, 90.6%, 94.2%, and 99.0% in modified ITT (MITT) analysis, and 90.4%, 94.1%, and 99.0% in per‐protocol (PP) analysis. Although there was non‐inferiority between BM‐TID and AM‐TID, as well as between AM‐TID and AM‐QID, AM‐QID was significantly more effective than BM‐TID. There were no significant differences in adverse event rates, compliance, and antibiotic resistance among the three groups. Conclusions: Postprandial administration and the increased frequency of administration of amoxicillin may contribute to a better efficacy of VA‐dual therapy, especially for rescue therapy. All VA‐dual therapy in our study could achieve good efficacy for first‐line treatment. Trial Registration:clinicaltrials.gov: NCT05901051. [ABSTRACT FROM AUTHOR]

Background: Vonoprazan, a potassium‐competitive acid blocker, is superior to traditional proton pump inhibitor (PPI) in acid suppression and has been approved in the treatment of acid‐related disorders. Accumulating evidence suggest associations between PPI use and gut microbiota, yet the effect of vonoprazan on GI microbiota is obscure. Methods: Transgenic FVB/N insulin‐gastrin (INS‐GAS) mice as a model of gastric cancer (GC) were administered vonoprazan by gavage every other day for 12 weeks. Stomachs were evaluated by histopathology, Ki‐67 proliferation index, and inflammatory cytokines. The mucosal and lumen microbiota from stomach, jejunum, ileum, cecum, and feces were detected using 16S rRNA gene sequencing. Results: Higher incidence of intestinal metaplasia and epithelial proliferation were observed in the vonoprazan group than that in the control mice. Vonoprazan also elevated the gastric expression of proinflammatory cytokines, including TNF‐α, IL‐1β, and IL‐6. Each mice comprised a unique microbiota composition that was consistent across different niches. The structure of GI microbiota changed dramatically after vonoprazan treatment with the stomach being the most disturbed segment. Vonoprazan administration shifted the gut microbiota toward the enrichment of pathogenic Streptococcus, Staphylococcus, Bilophila, and the loss of commensal Prevotella, Bifidobacterium, and Faecalibacterium. Interestingly, compared to the controls, microbial interactions were weaker in the stomach while stronger in the jejunum of the vonoprazan group. Conclusions: Long‐term vonoprazan treatment promoted gastric lesions in male INS‐GAS mice, with the disequilibrium of GI microbiome. The clinical application of vonoprazan needs to be judicious particularly among those with high risk of GC. [ABSTRACT FROM AUTHOR]

In this study, an environmentally sustainable fluorimetric method for determination of Vonoprazan fumarate (VON) in dosage forms using nanoprobes consisting of nitrogen and sulfur co‐doped carbon quantum dots (N, S‐CQDs). The N, S‐CQDs were prepared through a microwave‐assisted method in 30 s. The resulting N, S‐CQDs were characterized using transmission electron microscopy (TEM), high‐resolution transmission electron microscopy (HRTEM), Fourier transform infrared spectroscopy (FTIR), and X‐ray photoelectron spectroscopy (XPS). They exhibit fluorescence emission at 460 nm after excitation at 385 nm with a high quantum yield (60%). The analytical approach for VON determination relies on the quenching effect exerted by VON on the native fluorescence intensity of CQDs. The quenching mechanism was investigated using Stern–Volmer plots. The proposed method demonstrates linearity across a concentration range 10–80 μM (4.6–36.8 μg/mL) with corresponding limits of detection and quantitation calculated as 2.17 μM (0.99 μg/mL) and 6.58 μM (3.02 μg/mL), respectively. The method has been effectively utilized for the determination of VON in the pharmaceutical samples. Statistical comparison with reported RP‐HPLC has been performed to verify the accuracy and precision of the developed method. The environmental sustainability of the developed method has been thoroughly examined through various greenness metrics. [ABSTRACT FROM AUTHOR]

Background: In Chinese healthcare settings, drug selection decisions are predominantly influenced by the Pharmacy & Therapeutics Committee (PTC). This study evaluates two recently introduced potassium-competitive acid blockers, vonoprazan (VPZ) and tegoprazan (TPZ), utilizing the Evidence and Value: Impact on DEcisionMaking (EVIDEM) framework. Methods: The study employed the 10th edition of EVIDEM, which includes a core model with five domains and 13 criteria. Two independent expert panels were involved: the PTC expert panel, tasked with assigning weights using a 5-point scale, defining scoring indicators, examining the evidence matrix, scoring, and decision-making; and the evidence matrix expert panel, responsible for conducting a systematic literature review, creating the evidence matrix, and evaluating the value contributions of VPZ and TPZ. Results: The analysis estimated the value contributions of VPZ and TPZ to be 0.59 and 0.54, respectively. The domain of 'economic consequences of intervention' showed the most significant variation in value contribution between the two drugs, followed by 'comparative outcomes of intervention' and 'type of benefit of intervention'. Conclusion: Employing the EVIDEM framework, VPZ's value contribution was found to be marginally superior to that of TPZ. The EVIDEM framework demonstrates potential for broader application in Chinese medical institutions. [ABSTRACT FROM AUTHOR]

Background: Proton pump inhibitor (PPI) therapy is well-established for its effectiveness in reducing re-bleeding in high-risk peptic ulcer patients following endoscopic hemostasis. Vonoprazan (VPZ) has demonstrated the capacity to achieve gastric pH levels exceeding 4, comparable to PPIs. This study aims to evaluate the comparative efficacy of intravenous PPI infusion versus VPZ in preventing re-bleeding after endoscopic hemostasis in patients with high-risk peptic ulcers. Methods: A randomized, double-blind, controlled, and double-dummy design was employed. Patients with peptic ulcer bleeding (Forrest class IA/IB or IIA/IIB) who underwent endoscopic hemostasis were randomly assigned to either the PPI group or the VPZ group. Re-bleeding rates at 3, 7, and 30 days, the number of blood transfusions required, length of hospitalization, and ulcer healing rate at 56 days were assessed. Results: A total of 44 eligible patients were enrolled, including 20 patients (PPI group, n = 11; VPZ group, n = 9) with high-risk peptic ulcers. The mean age was 66 years, with 70% being male. Re-bleeding within 72 h occurred in 9.1% of the PPI group versus 0% in the VPZ group (p = 1.000). There was no significant difference in re-bleeding rates within 7 days and 30 days (18.2% vs. 11.1%, p = 1.000). Additionally, the ulcer healing rate did not significantly differ between the groups (87.5% vs. 77.8%). Conclusions: This pilot study demonstrates comparable efficacy between oral vonoprazan and continuous PPI infusion in preventing recurrent bleeding events among high-risk peptic ulcer patients following successful endoscopic hemostasis. [ABSTRACT FROM AUTHOR]

A new, sensitive, and rapid isocratic reversed phase chromatographic method (RP-HPLC–UV) was developed for simultaneous separation of two newly co-formulated antiulcer mixtures; Amoxicillin, Vonoprazan and Clarithromycin [Mixture (I)], and Amoxicillin, Lansoprazole and Clarithromycin [Mixture (II)]. Analytical separation was performed using a Promosil C18 column and ultraviolet detection at 210 nm. The separation was achieved within only 8 min. For both mixtures, an aqueous solution, composed of (Acetonitrile: Methanol: 0. 2 M phosphoric acid) within ratio of (30: 30: 40) adjusted to final pH 3.0, was the mobile phase. This method was validated as per the International Conference on Harmonization guidelines. The linearity ranges of these proposed method of the (Mixture (I)) were 25.0–400.0 µg/mL Amoxicillin, 0.5–8.0 µg/mL Vonoprazan, and 12.5–200.0 µg/mL Clarithromycin. And the linearity ranges of the (Mixture (II)) were 10.0–300.0 µg/mL Amoxicillin, 0.3–9.0 µg/mL Lansoprazole and 5.0–150.0 µg/mL Clarithromycin. This method was firstly applied for effective separation of Amoxicillin, Vonoprazan and Clarithromycin [Mixture (I)]. It fulfilled good repeatability, sensitivity, and accuracy (R.S.D. < 2.0%). The mean recoveries of the analytes in their Tri-Pak formulations were acceptable. The greenness of the developed chromatographic methods was assessed using an Eco-scale method and it was applied for content uniformity testing as per the United States Pharmacopoeia (USP) and the acceptance value of Amoxicillin, in Mixture (I) was 2.88, the acceptance values for Amoxicillin, Lansoprazole in Mixture (II) were 2.592, 2.424, respectively. [ABSTRACT FROM AUTHOR]

Background and Aim: Healing rates of severe erosive esophagitis (EE; Los Angeles [LA] Grade C/D) in patients treated with a proton pump inhibitor (PPI) is suboptimal (~60–70%). Vonoprazan, a potassium‐competitive acid blocker, is suggested to have better healing rates in patients with severe EE. This meta‐analysis compares the efficacy and safety of vonoprazan 20 mg versus lansoprazole 30 mg daily in healing EE, specifically in those with LA Grade C/D. Methods: We searched MEDLINE, Embase, and CENTRAL on May 24, 2023. Studies that randomized EE patients to vonoprazan 20 mg daily or lansoprazole 30 mg daily and compared healing rates were included. The risk of bias was assessed using Cochrane's Risk of Bias 2 tool. The fixed‐effect model was used to obtain the pooled efficacy and safety outcomes. Subgroup analysis was done to compare healing rates in mild (LA Grade A/B) versus severe EE and based on study location. Results: Four randomized controlled trials (RCTs) with low risks of bias comprising 2208 participants were included. Vonoprazan 20 mg was superior to lansoprazole 30 mg daily in healing severe EE at all weeks (Week 2 RR 1.294 [95% CI 1.169–1.433], Week 4 1.160 [1.059–1.270], and Week 8 1.175 [95% CI 1.107–1.247]), but was similar for mild EE at all weeks (P‐interaction < 0.01). Vonoprazan 20 mg was more efficacious than lansoprazole 30 mg at Week 8 in Western versus Asian studies (P‐interaction < 0.01). Any, serious, and drug‐related treatment‐emergent adverse events were comparable between groups. Conclusion: Vonoprazan 20 mg is superior to lansoprazole 30 mg for healing severe EE but not mild EE. Vonoprazan 20 mg daily has a similar safety profile to lansoprazole 30 mg daily. [ABSTRACT FROM AUTHOR]

Background: Vonoprazan-based triple therapy has recently been reported as being more effective than proton pump inhibitors for the eradication of Helicobacter pylori (H. pylori), but it is apparent that the eradication rate could be further improved. Methods: We investigated the effect of the concomitant use of polaprezinc, a therapeutic agent for gastric ulcers, and vonoprazan-based seven-day triple therapy in patients with gastric ulcers compared to standard vonoprazan-based seven-day triple therapy in patients with atrophic gastritis. The regimen for the treatment of atrophic gastritis contained vonoprazan 20 mg, amoxicillin 750 mg, and clarithromycin 200 mg b.d. (VAC group) for seven days; and that for gastric ulcers contained VAC and polaprezinc 75 mg b.d. (VACP group) for seven days. Results: Between October 2021 and January 2023, 201 subjects were examined (VAC group, n = 165; VACP group, n = 36). In per-protocol (PP) analysis, the eradication rate was significantly higher in the VACP group (100%) than in the VAC group (88.2%) (p = 0.025). In patients with severe atrophic gastritis, eradication rates were significantly higher in the VACP group (100%) than in the VAC group (84.4%) in PP analysis. (p = 0.024). Conclusions: The concomitant use of polaprezinc and standard vonoprazan-based first-line eradication therapy is effective for H. pylori. [ABSTRACT FROM AUTHOR]

Background: Vonoprazan, a potassium-competitive acid blocker, demonstrates more potent acid inhibition than proton pump inhibitors (PPIs). This study aimed to evaluate the effect of vonoprazan in patients with unproven gastroesophageal reflux disease (GERD) by comparing patients with vonoprazan-refractory heartburn with those with PPI-refractory heartburn. Methods: This study included 104 consecutive patients with vonoprazan- or PPI-refractory heartburn (52 patients each), no erosive esophagitis on endoscopy and who underwent combined multichannel intraluminal impedance–pH (MII–pH) testing with vonoprazan/PPI discontinuation. Patients' backgrounds, symptom scores from four questionnaires, MII–pH results and high-resolution manometry results were compared between the two groups. Results: The vonoprazan group demonstrated significantly higher GERD symptoms and scores of abdominal pain and diarrhea on the Gastrointestinal Symptom Rating Scale questionnaire. MII–pH results revealed that the vonoprazan group demonstrated 40.4%, 17.3%, and 42.3% and the PPIs group exhibited 26.9%, 17.3%, and 55.8% of abnormal acid reflux [true non-erosive reflux disease (NERD)], reflux hypersensitivity and functional heartburn, respectively. The vonoprazan group demonstrated higher true NERD rates but with no significant difference (p = 0.307). Among the vonoprazan group, eight patients with true NERD underwent another MII–pH test on vonoprazan, and all cases demonstrated normal acid exposure times (0.0% [0.0–0.3]). Conclusion: Patients with unproven GERD with vonoprazan-refractory heartburn demonstrated more symptoms, including not only GERD symptoms but also functional dyspepsia and irritable bowel syndrome symptoms, than those with PPI-refractory heartburn. [ABSTRACT FROM AUTHOR]

Previous studies confirm vonoprazan-amoxicillin effectiveness for Helicobacter pylori. This study aims to investigate vonoprazan with varying amoxicillin dose and duration. This multicenter, prospective, randomized controlled, noninferiority trial enrolled patients with treatment naive H pylori infection from 5 clinical centers. Eligible participants were randomly assigned to H-VA-10 (vonoprazan 20 mg twice a day (b.i.d.) + amoxicillin 750 mg 4 times a day, 10 days), L-VA-10 (vonoprazan 20 mg b.i.d. + amoxicillin 1000 mg b.i.d, 10 days), and H-VA-14 (vonoprazan 20 mg b.i.d + amoxicillin 750 mg 4 times a day, 14 days) in a 1:1:1 ratio. The eradication rate was assessed using the 13C-urea breath test at least 28 days after treatment. Of the 623 eligible patients, 516 patients were randomized. In both the intention-to-treat and per-protocol analyses, eradication rates were comparable between H-VA-10 and H-VA-14 groups (86.6% vs 89.5% and 90.9% vs 94.5%, P =.021 and.013 for noninferiority, respectively). However, eradication rates were significantly lower in the L-VA-10 group than the H-VA-14 group (79.7% vs 89.5% and 82.0% vs 94.5%, P =.488 and.759, respectively). Rates of study withdrawal, loss to follow-up, and adverse events were similar across study groups. H-VA-10 and H-VA-14 regimens provide satisfactory efficacy for H pylori infection, and the L-VA-10 regimen was inferior. ClinicalTrials.gov number: NCT05719831. [ABSTRACT FROM AUTHOR]

Background and aimsVonoprazan, a novel acid suppressant, has been employed in the treatment of peptic ulcer disease in recent years. However, the efficacy and safety of vonoprazan versus proton-pump inhibitors remains controversial. To address this gap, a systematic review and network meta-analysis were conducted to evaluate the efficacy and safety of vonoprazan in comparison with various proton-pump inhibitors.MethodsRandomized controlled trials that met selection criteria in PubMed (Medline), EMBASE and the Cochrane Library were searched up to July 15, 2024. The primary outcome was ulcer healing rate. Secondary outcomes were treatment-emergent adverse events and drug-related adverse events. Effect size on outcomes is presented as odds ratios with 95% confidence intervals.ResultsThirty-five randomized controlled trials containing 9,544 participants were included. In terms of the healing rate at 2 weeks, lansoprazole 30 mg ranked first, followed by vonoprazan 20 mg and ilaprazole 10 mg. In terms of the healing rate at 4 weeks, pantoprazole 40 mg ranked first, with rabeprazole 10 mg and lansoprazole 30 mg ranking second and third, respectively. Regarding the healing rate at 8 weeks, lansoprazole 30 mg is demonstrated to be the most efficacious regimen. Moreover, subgroup analysis indicated that lansoprazole 30 mg is the optimal regimen in the treatment of artificial gastric ulcer at 4 and 8 weeks. Importantly, lansoprazole 30 mg has fewer adverse reactions and higher safety.ConclusionThe optimal regimen for the treatment of peptic ulcer disease may be lansoprazole 30 mg at 2 and 8 weeks, while pantoprazole 40 mg has demonstrated superior performance at the 4-week when compared to vonoprazan 20 mg. Furthermore, lansoprazole 30 mg has shown to be superior in terms of safety outcomes. These findings, derived from a network meta-analysis, necessitate further research for validation.

Abstract Background Although proton pump inhibitors (PPIs) or potassium-competitive acid blocker (PCAB) are useful in peptic ulcer prevention, their efficacy in preventing other gastrointestinal bleeding remains unclear. This study aimed to identify the status of gastrointestinal bleeding in the modern era when PPIs are widely used. Methods This study included patients who underwent percutaneous coronary intervention (PCI) between 2018 and 2019 at two high-volume centers. Patients were categorized based on whether they experienced gastrointestinal bleeding within 2 years of PCI into groups A (patients who experienced gastrointestinal bleeding within 2 years after PCI) and B (patients who did not experience gastrointestinal bleeding). Results Groups A and B included 21 (4.1%) and 494 (95.9%) patients, respectively (a total of 515 patients). Age at the initial PCI (77.8±2.4 and 72.0±0.5 years in groups A and B, respectively; p = 0.02), weight (53.8±3.2 and 61.8±0.7 kg in groups A and B, respectively; p = 0.01), and concomitant warfarin use (14.3% and 2.0% in groups A and B, respectively; p = 0.0005) were significantly different between the groups. The high bleeding risk rate (90.5% and 47.6% in groups A and B, respectively; p = 0.0001) was significantly different between the groups. A total of 95.9% of patients were taking PPIs or PCAB without significant differences between the groups. However, only one patient, who was taking steroids, had a gastric ulcer during PCAB treatment. Conclusions Acid-related upper gastrointestinal bleeding is largely controlled by PPIs in post-PCI patients. Furthermore, the risk factors for non-acid-related bleeding include older age, lower weight, and concomitant warfarin use.