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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: 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]

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]

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 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.

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: 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: 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]

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.

Abstract Helicobacter pylori has a big sway when peptic ulcers are concerned. For its eradication, different protocols have been approved. Among which, the tripartite therapy protocol which embraces vonoprazan as potassium competitive acid blocker in combination with amoxicillin and metronidazole as antibiotics. An environmentally benign HPLC method is addressed in order to simultaneously determine amoxicillin (AMX), metronidazole (MET) and vonoprazan (VPZ) in bulk powder and combined tablet mixture. Full separation of AMX, MET and VPZ is accomplished using C8 column, and a gradient mobile phase system, composed of methanol and phosphate buffer of a pH value of 5. Fine linearity in the concentration ranges 50–600 µg mL−1 amoxicillin, 50–400 µg mL−1 metronidazole and 10–100 µg mL−1 vonoprazan was denoted by the high correlation coefficient (0.9999). The method accuracy and precision are confirmed upon analyzing AMX, MET and VPZ triple therapy not only in their synthetic mixtures and combined tablet mixtures but also in their combined tablet mixtures in simulated gastric fluid. AMX, MET and VPZ triple therapy could be routinely analyzed in QC labs, in case of being co-formulated, using the presented method. Three different assessment tools were adopted revealing the benign environmental impact of presented method.

Abstract Objective To compare the potential efficacy and safety of dual therapy and quadruple therapy with vonoprazan (VPZ) as well as the standard quadruple therapy of proton pump inhibitor (PPI) for the eradication of Helicobacter pylori (Hp) infection in Hainan province. Methods A single-centre, non-blinded, non-inferiority randomized controlled trial was conducted at the outpatient department of gastroenterology at the Second Affiliated Hospital of Hainan Medical University from June 2022 to February 2023. 135 patients aged 18–75 years with Hp infection were enrolled and randomized into three different groups (group V1: VPZ 20 mg twice a day and amoxicillin 1.0 g three times a day for 14 days V2: vonoprazan 20 mg, amoxicillin capsules 1.0 g, furazolidone 0.1 g and bismuth potassiulm citrate 240 mg, twice daily for 14 days;; group V3: ilaprazole 5 mg, Amoxicillin 1.0 g, Furazolidone 100 mg, bismuth potassiulm citrate 240 mg, twice a day for 14 days). Four weeks after the end of treatment, Hp eradication was confirmed by rechecking 13C-urea breath test (UBT). Results The eradication efficacy of V1 and V3 was non-inferior to that of V2, which is consistent with the results obtained from the Kruskal-Wallis H test. The eradication rate by intentional analysis was 84.4% (38/45, 95%CI 73.4%–95.5%, P>0.05) for all the three groups. If analyzed by per-protocol, the eradication rates were 88.4% (38/43, 95%CI 78.4%–98.4%), 92.7% (38/41, 95%CI 84.4%–101.0%),88.4% (38/43，95%CI 78.4%–98.4%) in groups V1, V2 and V3, respectively, which did not show a significant difference (P > 0.05). The incidence of adverse effects was significantly lower in VPZ dual therapy compared to the other two treatment regimens (P

Abstract Background Both vonoprazan and proton pump inhibitors (PPIs) are currently used to treat artificial ulcers after gastric endoscopic submucosal dissection. However, evidence-based medicine proving the efficacy of vonoprazan is still lacking. Therefore, this meta-analysis aimed to compare the efficacy of vonoprazan and PPIs for the treatment of artificial ulcers after gastric endoscopic submucosal dissection. Methods The PubMed, EMBASE and Cochrane Library databases were searched up to September 2023 for related randomized controlled trials (RCTs). RCTs that compared the efficacy of vonoprazan and PPIs in treating artificial gastric ulcers after gastric endoscopic submucosal dissection were included. Two independent reviewers screened the included studies, extracted the data and assessed the risk of bias. The following outcomes were extracted for comparison: ulcer healing rate, ulcer shrinkage rate, delayed postoperative bleeding rate, and ulcer perforation rate. Results Nine randomized controlled trials involving 926 patients were included. The pooled results showed that vonoprazan had a significantly lower rate of delayed postoperative bleeding than did PPIs (RR = 0.46; 95% CI = 0.23–0.91; P = 0.03). No significant differences were found in terms of ulcer healing, shrinkage rates, or ulcer perforation rates between vonoprazan and PPIs. Conclusions Compared with PPIs, vonoprazan is superior at reducing delayed postoperative bleeding after endoscopic submucosal dissection. However, further studies are needed to prove the efficacy of vonoprazan. Systematic Review Registration Identifier CRD42024509227.

Objective To evaluate clinical efficacy of the combination of Vonoprazan and high-dose Amoxicillin in the initial eradication treatment of Helicobacter pylori （Hp）. Methods Select 200 patients with Hp infection who have not undergone Hp eradication treatment in the past as the research subjects. All patients were randomly divided into the observation group （n = 100） and control group （n = 100） using random number table method. In the observation group， a combination regimen of Vonoprazan （20 mg twice a day） and Amoxicillin （1 g three times a day） was given for 14 days. In the control group， a bismuth quadruple therapy was delivered for 14 days， which included Esomeprazole （20 mg twice a day）， Bismuth Potassium Citrate （220 mg twice a day）， Amoxicillin （1 g twice a day） and Clarithromycin （0.5 g twice a day）. The Hp eradication rate and incidence of adverse reactions after medication were compared between two groups. Results Of 200 patients， 11 patients were excluded from subsequent analysis， including 8 cases lost to follow-up and 3 cases with poor compliance of medication. The remaining 189 patients （96 in the observation group and 93 in the control group） completed the entire procedure. According to intention-to-treat （ITT） and per-protocol （PP） set analyses， the Hp eradication rate in the observation group was significantly higher than that in the control group （91.0% vs. 79.0%， PITT =0.017； 94.8% vs. 84.9%， PPP= 0.024）. The incidence of adverse reactions did not significantly differ between two groups （4% vs. 5%，χ 2 < 0.001，P > 0.999）. Conclusion The combination therapy of Vonoprazan and high-dose Amoxicillin is an efficacious and safe therapeutic option for patients with initial Hp infection， which is worthy of promotion in grassroot-level hospitals.

Helicobacter pylori has a big sway when peptic ulcers are concerned. For its eradication, different protocols have been approved. Among which, the tripartite therapy protocol which embraces vonoprazan as potassium competitive acid blocker in combination with amoxicillin and metronidazole as antibiotics. An environmentally benign HPLC method is addressed in order to simultaneously determine amoxicillin (AMX), metronidazole (MET) and vonoprazan (VPZ) in bulk powder and combined tablet mixture. Full separation of AMX, MET and VPZ is accomplished using C8 column, and a gradient mobile phase system, composed of methanol and phosphate buffer of a pH value of 5. Fine linearity in the concentration ranges 50–600 µg mL−1 amoxicillin, 50–400 µg mL−1 metronidazole and 10–100 µg mL−1 vonoprazan was denoted by the high correlation coefficient (0.9999). The method accuracy and precision are confirmed upon analyzing AMX, MET and VPZ triple therapy not only in their synthetic mixtures and combined tablet mixtures but also in their combined tablet mixtures in simulated gastric fluid. AMX, MET and VPZ triple therapy could be routinely analyzed in QC labs, in case of being co-formulated, using the presented method. Three different assessment tools were adopted revealing the benign environmental impact of presented method. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The efficacy and safety of potassium-competitive acid blockers (P-CABs) in the eradication of Helicobacter pylori (Hp) remains controversial when compared with proton pump inhibitors (PPIs). Objectives: The current study set out to compare the differences in the eradication rate and adverse reactions between eradication regimens based on P-CAB or PPI drugs and the differences between the vonoprazan-based and the tegoprazan-based regimens to explore the efficacy and safety of different Hp eradication regimens. Data sources and methods: Databases including PubMed, EMBASE, Cochrane Library, and WOS were searched from the inception of these databases up to July 2023, and eligible randomized controlled trials (RCTs) were included. The outcome measures were the eradication rate and the incidence of adverse reactions of different regimens in treating Hp. The results were estimated as relative risk (RR) and its 95% confidence interval (CI), and R 4.2.1 software was used to perform the network meta-analysis (NMA). Results: A total of 20 studies were included in the analysis, involving 5815 patients with Hp. In terms of eradication rate, the 2-week vonoprazan-based triple regimen (V-Tri-2w) was the best, which was superior to the 2-week PPI-based quadruple regimen [P-Qua-2w, RR = 0.9, 95% CI: (0.85–0.95)] and the 1-week tegoprazan-based triple regimen [T-Tri-1w, RR = 0.79, 95% CI: (0.64–0.97)]; the 2-week tegoprazan-based quadruple regimen (T-Qua-2w) was superior to the 1-week PPI-based triple regimen [P-Tri-1w, RR = 0.82, 95% CI: (0.67–0.99)], and there was no difference between the remaining tegoprazan-based regimens and the PPI-based or vonoprazan-based regimens. In terms of the incidence of adverse reactions, the 2-week vonoprazan-based binary regimen (V-Bi-2w) was lower than that of the 2-week PPI-based quadruple regimen [P-Qua-2w, RR = 1.98, 95% CI: (1.57–2.52)]; there was no significant difference between 1 and 2 weeks for each regimen, such as the vonoprazan-based triple regimen [RR = 1.11, 95% CI: (0.82–1.52)]. Conclusion: In the eradication treatment of Hp, the efficacy and safety of vonoprazan-based regimens are generally better than those of PPI-based regimens. Among them, the V-Tri-2w regimen has the highest eradication rate and may be the preferred choice for Hp eradication. [ABSTRACT FROM AUTHOR]

Background and Aim: To evaluate the efficacy and safety of minocycline, vonoprazan, amoxicillin, and bismuth quadruple therapy for Helicobacter pylori (H. pylori) treatment. Methods: From August 2022 to May 2023, clinical data were collected from patients who received H. pylori eradication treatment at West China Fourth Hospital, Sichuan University. One group received the MVAB regimen (amoxicillin, minocycline, vonoprazan, and colloidal bismuth pectin), while another group received the FOAB regimen (amoxicillin, furazolidone, omeprazole, and colloidal bismuth pectin), both administered for 14 days. Follow‐up assessments of safety and compliance were conducted within 1 week after treatment completion. One and a half months after treatment, the success of eradication was evaluated using the urea breath test. Results: For the MVAB regimen as a first‐line treatment, the eradication rate was 90.1% (127/141, 95% CI: 85.1–95.1%) in the ITT analysis and 93.4% (127/136, 95% CI: 89.2–97.6%) in the PP analysis as a first‐line treatment. As a second‐line treatment, the eradication rate was 91.3% (21/23, 95% CI: 78.8–103.8%) in both analyses. For the FOAB regimen as a first‐line treatment, the eradication rate was 98.0% (50/51, 95% CI: 94.1–101.2%) in the ITT analysis and 100% (50/50, 95% CI: 100%) in the PP analysis. As a second‐line treatment, the eradication rate was 100% (6/6, 95% CI: 100%) in both analyses. Moreover, there was no significant difference in the incidence of adverse events between the two groups (MVAB regimen: 5.5% and FOAB regimen: 8.8%; P > 0.05). Conclusions: The MVAB regimen could indeed be a viable alternative treatment option to conventional therapies. [ABSTRACT FROM AUTHOR]

Introduction: The eradication rate of Helicobacter pylori (H. pylori) has decreased due to antibiotics resistance and inadequate acid suppression. Vonoprazan is a novel potassium-competitive acid blocker (P-CAB), which has a rapid and sustained acid inhibitory effect and may be more effective than conventional proton pump inhibitors (PPIs) in H. pylori eradication. Aim: to study the efficacy and safety of vonoprazan as a component of first-line H. pylori eradication treatment compared with conventional PPI-based therapy. Material and methods: This randomised (one to one) non-blinded study was conducted on 400 consecutive proven H. pylori infected patients, of whom 200 received vonoprazan-based triple therapy, while 200 patients received PPI-based triple therapy for 14 days. The study outcomes were evaluated as eradication rate and adverse events in both patient groups. Results: The eradication rate was 86% in the vonoprazan group and 74.5% in the PPI group. The vonoprazan eradication rate was significantly higher than that of PPIs (p = 0.004). There was no significant difference regarding adverse events between both patient groups. Conclusions: Vonoprazan-based therapy was more effective than PPI-based therapy as a first-line H. pylori eradication treatment. Vonoprazan was generally safe and well tolerated. [ABSTRACT FROM AUTHOR]

Background and Aim: To date, no randomized trials have compared the efficacy of 7‐day vonoprazan, amoxicillin, and metronidazole triple therapy (VAM) versus 7‐day vonoprazan, amoxicillin, and clarithromycin triple therapy (VAC) as a first‐line treatment for Helicobacter pylori eradication. This study was performed to compare the efficacy of VAM and VAC as first‐line treatments. Methods: This prospective multicenter randomized trial was performed in Japan and involved 124 H. pylori‐positive patients without a history of eradication. Patients without antibiotic resistance testing of H. pylori were eligible. The patients were randomized to receive either VAC (vonoprazan 20 mg + amoxicillin 750 mg + clarithromycin 200 or 400 mg twice a day) or VAM (vonoprazan 20 mg + amoxicillin 750 mg + metronidazole 250 mg twice a day) for 7 days, with stratification by age and sex. Eradication success was evaluated using the 13C‐urea breath test. We evaluated safety using patient questionnaires (UMIN000025773). Results: The intention‐to‐treat and per‐protocol eradication rates of VAM were 91.3% (95% confidence interval [CI], 82.0–96.7%) and 92.6% (95% CI, 83.7–97.6%), respectively, and those of VAC were 89.1% (95% CI, 77.8–95.9%) and 96.1% (95% CI, 86.5–99.5%), respectively. No significant difference was observed between VAM and VAC in either analysis (P = 0.76 and P = 0.70, respectively). Abdominal fullness was more frequent in patients who received VAM than VAC. Conclusions: These findings suggest that VAM as a first‐line treatment in Japan can be categorized as grade B (intention‐to‐treat cure rate of 90–95%) and have potential as a first‐line national insurance ‐approved regimen. [ABSTRACT FROM AUTHOR]

Background: Both vonoprazan and proton pump inhibitors (PPIs) are currently used to treat artificial ulcers after gastric endoscopic submucosal dissection. However, evidence-based medicine proving the efficacy of vonoprazan is still lacking. Therefore, this meta-analysis aimed to compare the efficacy of vonoprazan and PPIs for the treatment of artificial ulcers after gastric endoscopic submucosal dissection. Methods: The PubMed, EMBASE and Cochrane Library databases were searched up to September 2023 for related randomized controlled trials (RCTs). RCTs that compared the efficacy of vonoprazan and PPIs in treating artificial gastric ulcers after gastric endoscopic submucosal dissection were included. Two independent reviewers screened the included studies, extracted the data and assessed the risk of bias. The following outcomes were extracted for comparison: ulcer healing rate, ulcer shrinkage rate, delayed postoperative bleeding rate, and ulcer perforation rate. Results: Nine randomized controlled trials involving 926 patients were included. The pooled results showed that vonoprazan had a significantly lower rate of delayed postoperative bleeding than did PPIs (RR = 0.46; 95% CI = 0.23–0.91; P = 0.03). No significant differences were found in terms of ulcer healing, shrinkage rates, or ulcer perforation rates between vonoprazan and PPIs. Conclusions: Compared with PPIs, vonoprazan is superior at reducing delayed postoperative bleeding after endoscopic submucosal dissection. However, further studies are needed to prove the efficacy of vonoprazan. Systematic Review Registration: Identifier CRD42024509227. [ABSTRACT FROM AUTHOR]

Helicobacter pylori is a class I carcinogen that infects more than 100 million individuals in the United States. Antimicrobial therapy for H. pylori has typically been prescribed empirically rather than based on susceptibility testing. Until recently, therapeutic recommendations have generally ignored the principles of antibiotic stewardship. A combination of a proton pump inhibitor (PPI), amoxicillin, and clarithromycin (triple therapy) remains popular despite increasing clarithromycin resistance and poor cure rates. Concomitant therapy (a PPI, amoxicillin, clarithromycin, and metronidazole) is recommended and widely used despite all patients receiving at least one unneeded antibiotic. In 2020, the Food and Drug Administration approved vonoprazan, amoxicillin, and clarithromycin triple therapy, which administers unneeded clarithromycin to >90% of patients (i.e., ~6 tons of unneeded clarithromycin/million treatments). In the late 1980s, the infectious disease community functionally transferred responsibility for the management of H. pylori to gastroenterology, which has managed the infection as another common gastrointestinal disease such as constipation. In 2022, both traditional and noninvasive molecular-based susceptibility testing for H. pylori became available in the United States. In order to reduce and prevent antibiotic misuse, the infectious disease community should reclaim responsibility for the management of this important infectious disease. [ABSTRACT FROM AUTHOR]

Objectives: To compare efficacy of 10-mg of vonoprazan daily & on alternate days by Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) Method: This prospective interventional cohort was done at Department of Medicine/Gastroenterology Dow Medical College, Karachi, Pakistan during the period August 2022 & January 2023. Potential participants fulfilling inclusion and exclusion criteria were asked to fill out GSAS questionnaires after their written consent. Patients were allocated in to two groups using random tables. Group-A was given Tab Vonoprazan 10-mg daily for two weeks. Group-B was given Tab Vonoprazan 10-mg on alternate day. GSAS was scored by totaling scores across symptoms and then they are divided by the total number of non-missing symptom scores. Both groups were assessed week-0 & week-2. Results: Only 90 proformas that were completely filled were included, Group-A had 30 males and 15 females while Group-B had 29 males and 16 females. No significant difference in score was found in GSAS score at week-0 except that in item 'gurgling' while at week two there was no significant difference between any of the items. Total GSAS score were significantly lower at Week-2 than at week-0 (p = <.001). Conclusions: Vonoprazan of 10-mg on alternate day is equally effective as 10-mg daily in maintenance of GERD patients at two weeks. [ABSTRACT FROM AUTHOR]

Introduction: Proton pump inhibitor (PPI) is the mainstay therapy for the maintenance of healed erosive esophagitis (EE). It is unknown whether potassium‐competitive acid blockers (PCABs) are more efficacious and safer than PPIs. Methods: Only randomized controlled trials (RCTs) comparing PCABs to PPIs in the maintenance of healing rates of endoscopically proven healed EE and indexed in MEDLINE, EMBASE, and CENTRAL until 3 February 2024, were included. A fixed‐effects model meta‐analysis was performed to pool primary efficacy outcome (maintenance of healing rates at week 24) and safety data (any treatment‐emergent adverse event or TEAE). The risk of bias was assessed using Cochrane's Risk of Bias 2 (RoB2) tool. Results: Four RCTs with a total of 2554 patients were eligible for inclusion. All trials were of low risk of bias. Compared to lansoprazole 15 mg, the maintenance rates of healed EE at week 24 were significantly higher with vonoprazan 10 mg (RR 1.13; 95% CI 1.07–1.19) and vonoprazan 20 mg (RR 1.15; 95% CI 1.10–1.21). Likewise, compared to lansoprazole 15 mg, any TEAEs were significantly greater with vonoprazan 20 mg (RR 1.10; 95% CI 1.01–1.20) but not vonoprazan 10 mg. Conclusion: Vonoprazan 10 and 20 mg were superior to lansoprazole 15 mg in the maintenance of the healing of EE. Any TEAEs were greater with vonoprazan 20 mg. [ABSTRACT FROM AUTHOR]

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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.

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 Background and Aim Whether alcohol intake is associated with Helicobacter pylori (H. pylori) eradication failure remains controversial, and this meta-analysis was aimed at investigating the effect of alcohol on the risk of H. pylori eradication failure. Methods Relevant studies were systematically screened for and retrieved from PubMed and Web of Science (updated to January 2022), and relevant references were manually reviewed. The odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. Subgroup, publication bias, and sensitivity analyses were also conducted. Results A total of 40 studies were included in the meta-analysis. No significant association was found between alcohol consumption and the risk of H. pylori eradication failure (OR = 1.09, 95% CI, 0.94–1.26). However, in subgroup analyses stratified by region, a positive association was found in Asian patients (OR = 1.23, 95% CI, 1.03–1.47). In Asian patients, alcohol consumption was associated with the risk of H. pylori eradication failure when the duration of therapy was > 7 days (OR = 1.17, 95% CI, 1.10–1.25), when the treatment regimen included nitroimidazoles (OR = 1.16, 95% CI, 1.09–1.24), and when patients were treated with bismuth-containing quadruple therapy (OR = 1.17, 95% CI, 1.10–1.25). Alcohol intake > 40 g/day was associated with H. pylori eradication failure (OR = 3.17, 95% CI, 1.56–6.41). Moreover, in Asian patients who were administered a vonoprazan (VPZ)-based therapy regimen, alcohol consumption had no effect on H. pylori eradication rates (OR = 1.73, 95% CI, 0.98–3.05). Conclusion Our meta-analysis clearly showed that a higher daily alcohol intake was associated with a higher risk of H. pylori eradication failure in Asian populations. Moreover, a VPZ-based treatment regimen can prevent this effect.

Background: Helicobacter pylori [H. Pylori] infection is a major risk factor for the development of gastric cancer. Gastric cancer witnessed a significant increase in recent decades. Thus, eradication of H. Pylori could reduce the incidence of gastric cancer. However, the standard treatment is not yet determined. Aim of the Work: To evaluate the efficacy of Vonoprazan [VPZ]-based regimen compared-with proton pump inhibitors [PPI]-based regimen for H. pylori eradication therapy.Patients and Methods: This study included 150 patients with gastro-intestinal symptoms and H. Pylori positive test. They were divided into equal three groups according to treatment regimen. The first group [I] received PPI-based regiment [triple therapy; Clarithromycin 500 mg, amoxicillin 1gm, and PPI 40 mg] twice daily for two weeks. The second group [II] received vonoprazan-based regiment [triple therapy; Clarithromycin 500 mg, amoxicillin 1 gm, and vonoprazan 20 mg] twice daily for two weeks. The third group also for vonoprazan-based regimen [dual therapy; [amoxicillin 1gm –vonoprazan 20 mg] twice daily for two weeks. Results: The analysis indicates that the eradication rate of H. Pylori was 88% in group I, 92% in group II and 84% in group III. There was no significant difference between the three studied groups regarding eradication rate. In addition, groups were comparable regarding patient demographics except younger age of the first group than the second and third groups. Otherwise, no significant associations [differences] between groups were reported.Conclusion: Vonoprazan triple therapy is superior to PPI- triple therapy. The dual vonoprazan-therapy is highly recommended in case of clarithromycin resistant patients. Otherwise, the triple vonoprazan therapy is recommended.

As the rate of discovery of drug-resistant Helicobacter pylori cases increases worldwide, the relevant societies have updated their guidelines for primary eradication regimens. A promising strategy against drug-resistant H. pylori is tailored therapy based on the results of an antibiotic susceptibility test; however, it is difficult to apply this strategy to all cases. Although culture-based antibiotic susceptibility tests can assess resistance to any antimicrobial agent, their greatest disadvantage is the time required to draw a conclusion. In contrast, molecular-based methods, such as polymerase chain reaction, can rapidly determine the presence of resistance, although a single test can only test for one type of antimicrobial agent. Additionally, the limited availability of facilities for molecular-based methods has hindered their widespread use. Therefore, low-cost, minimally invasive, simple, and effective primary regimens are needed. Several studies have compared the efficacy of the latest primary eradication regimens against that of tailored therapies, and their results have shaped guidelines. This article reviews the latest research on empirical and tailored treatments for H. pylori infections. Evidence for the superiority of tailored therapy over empirical therapy is still limited and varies by region and treatment regimen. A network meta-analysis comparing different empirical treatment regimens showed that vonoprazan triple therapy provides a superior eradication effect. Recently, favorable results towards vonoprazan dual therapy have been reported, as it reached eradication levels similar to those of vonoprazan triple therapy. Both vonoprazan dual therapy and tailored therapy based on antibiotic susceptibility tests could contribute to future treatment strategies.

Abstract Background and Aim To evaluate the efficacy and safety of minocycline, vonoprazan, amoxicillin, and bismuth quadruple therapy for Helicobacter pylori (H. pylori) treatment. Methods From August 2022 to May 2023, clinical data were collected from patients who received H. pylori eradication treatment at West China Fourth Hospital, Sichuan University. One group received the MVAB regimen (amoxicillin, minocycline, vonoprazan, and colloidal bismuth pectin), while another group received the FOAB regimen (amoxicillin, furazolidone, omeprazole, and colloidal bismuth pectin), both administered for 14 days. Follow‐up assessments of safety and compliance were conducted within 1 week after treatment completion. One and a half months after treatment, the success of eradication was evaluated using the urea breath test. Results For the MVAB regimen as a first‐line treatment, the eradication rate was 90.1% (127/141, 95% CI: 85.1–95.1%) in the ITT analysis and 93.4% (127/136, 95% CI: 89.2–97.6%) in the PP analysis as a first‐line treatment. As a second‐line treatment, the eradication rate was 91.3% (21/23, 95% CI: 78.8–103.8%) in both analyses. For the FOAB regimen as a first‐line treatment, the eradication rate was 98.0% (50/51, 95% CI: 94.1–101.2%) in the ITT analysis and 100% (50/50, 95% CI: 100%) in the PP analysis. As a second‐line treatment, the eradication rate was 100% (6/6, 95% CI: 100%) in both analyses. Moreover, there was no significant difference in the incidence of adverse events between the two groups (MVAB regimen: 5.5% and FOAB regimen: 8.8%; P > 0.05). Conclusions The MVAB regimen could indeed be a viable alternative treatment option to conventional therapies.

Abstract Background and Aim To date, no randomized trials have compared the efficacy of 7‐day vonoprazan, amoxicillin, and metronidazole triple therapy (VAM) versus 7‐day vonoprazan, amoxicillin, and clarithromycin triple therapy (VAC) as a first‐line treatment for Helicobacter pylori eradication. This study was performed to compare the efficacy of VAM and VAC as first‐line treatments. Methods This prospective multicenter randomized trial was performed in Japan and involved 124 H. pylori‐positive patients without a history of eradication. Patients without antibiotic resistance testing of H. pylori were eligible. The patients were randomized to receive either VAC (vonoprazan 20 mg + amoxicillin 750 mg + clarithromycin 200 or 400 mg twice a day) or VAM (vonoprazan 20 mg + amoxicillin 750 mg + metronidazole 250 mg twice a day) for 7 days, with stratification by age and sex. Eradication success was evaluated using the 13C‐urea breath test. We evaluated safety using patient questionnaires (UMIN000025773). Results The intention‐to‐treat and per‐protocol eradication rates of VAM were 91.3% (95% confidence interval [CI], 82.0–96.7%) and 92.6% (95% CI, 83.7–97.6%), respectively, and those of VAC were 89.1% (95% CI, 77.8–95.9%) and 96.1% (95% CI, 86.5–99.5%), respectively. No significant difference was observed between VAM and VAC in either analysis (P = 0.76 and P = 0.70, respectively). Abdominal fullness was more frequent in patients who received VAM than VAC. Conclusions These findings suggest that VAM as a first‐line treatment in Japan can be categorized as grade B (intention‐to‐treat cure rate of 90–95%) and have potential as a first‐line national insurance ‐approved regimen.