Objectives: The aim of this study was to evaluate the bioequivalence (BE) of two oral tablet formulations of Vonoprazan (VNP) 20 mg in 30 healthy male subjects under fasting conditions. Materials and Methods: This study was a randomized, open-label, balanced, two-period, two-sequence, single oral dose, and crossover study. Thirty (30) healthy subjects were assigned to one of two sequences protocol: INZELM® 20 mg, as reference product (R) sequence R-T or VNP 20 mg as test product (T) sequence T-R to period I and vice versa to period II, with a washout period between the two periods. Pharmacokinetic (PK) parameters in plasma concentrations were determined using a validated Liquid Chromatography-Mass Spectrometry (LC-MS/MS) method. Results: The results showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of C max : 100.79% (94.55–107.44%), area under the curve (AUC) 0-t : 97.42% (92.72–102.35%), and AUC 0-inf : 97.35% (92.52–102.43%) were within the BE (80–125%) acceptance range. Conclusion: The PK profiles of INZELM® VNP 20 mg (Takeda Pharmaceutical Company Limited) as reference (R) product and VNP 20 mg (Laboratorios Leti, S.A.V) as test (T) product were bioequivalent. No adverse events were reported.

Background: A novel triple therapy regimen for Helicobacter pylori eradication, recently approved by the U.S. FDA, comprises vonoprazan (VPN), a potassium-competitive acid blocker, in combination with amoxicillin (AMX) and clarithromycin (CMN). This study presents the development and full validation of a rapid, selective, and sensitive LC-MS/MS method for the simultaneous quantification of these three drugs in spiked human plasma. Methods: Sample preparation was performed using a simple and efficient liquid–liquid extraction (LLE) technique. Chromatographic separation was achieved within 5 min using a Phenomenex Kinetex C18 column (100 × 4.6 mm, 2.6 µm) and a gradient elution system consisting of 0.1% formic acid in water and acetonitrile. Moreover, diazepam was used as an internal standard. The mass spectrometric detection was conducted in multiple reaction monitoring (MRM) mode using positive electrospray ionization. Results: The method exhibited excellent linearity over the investigated concentration ranges (2, 5, 10, 20, 50, and 100 ng/mL for amoxicillin and clarithromycin and 5, 10, 20, 30, 50, and 100 ng/mL for vonoprazan). Intra- and inter-day precision and accuracy values met FDA bioanalytical method validation guidelines, with relative standard deviations and relative errors below 15%. Mean absolute recoveries were above 93% for all analytes. Conclusions: The developed method was fully validated, rapid, selective, and sensitive LC-MS/MS and was assessed using the AGREE tool as a greenness assessment approach, confirming its environmental friendliness and alignment with green analytical chemistry principles.

Background:There is no consensus on whether proton pump inhibitor (PPI) or vonoprazan (VPZ) is superior in preventing delayed bleeding (DB) after endoscopic submucosal dissection (ESD) of the stomach.Objectives:This study aimed to compare the efficacy of combined intravenous and oral PPI versus oral VPZ alone therapy in preventing DB after gastric ESD in a consecutive and large case series.Design:Retrospective study.Methods:This study included consecutive patients who underwent gastric ESD at Chiba University Hospital from January 2017 to July 2023. Before 2019, patients received intravenous omeprazole 20 mg in the morning and evening on the day of ESD and the day after. Thereafter, esomeprazole 20 mg was administered orally once daily, which was continued for generally 28 days (defined as the PPI group). From 2020 onward, patients received oral VPZ 20 mg once daily starting on the day of ESD, also typically continued for 28 days (defined as the VPZ group). DB rates between the PPI and VPZ groups were compared using propensity score matching.Results:There were 720 cases (856 tumors) of gastric ESD during the study period, of which 352 (409 tumors) were in the PPI group and 368 (447 tumors) in the VPZ group. Propensity score matching for 9 covariates related to DB rates for gastric ESD ultimately produced 329 best matches. There was no significant difference in DB rates between the two groups (4.3% vs 3.6%, p = 0.84).Conclusion:Though further prospective studies are needed to draw definitive conclusions, it was suggested that the easily administered oral VPZ can be an important option for acid suppression after gastric ESD.

Helicobacter pylori is a primary cause of several gastrointestinal diseases, including chronic gastritis and gastric cancer. Unfortunately, standard treatments are increasingly failing due to rising antimicrobial resistance, particularly to clarithromycin. This necessitates the development of optimized H. pylori management strategies that minimize antibiotic use, reduce adverse effects, lower costs, and improve compliance. Vonoprazan-based regimens seem to be a viable option, as vonoprazan (VPZ) offers more consistent and potent acid suppression because it is not significantly affected by CYP2C19 genetic variations. This review comprehensively analyzed 43 clinical studies from the past five years in PubMed, evaluating the efficacy and safety of vonoprazan-based regimens for H. pylori eradication, including comparisons with established and novel therapies of varying doses and durations. The findings consistently demonstrate that VPZ-based therapies achieve comparable or superior eradication rates, alongside a more favorable safety profile and enhanced cost-effectiveness. While high-dose vonoprazan-amoxicillin (VA) therapy temporarily impacts gut microbiota and can persistently affect the antibiotic resistome, low-dose VA regimens show negligible effects. This highlights VA therapy as a promising candidate for an optimal H. pylori eradication strategy, though further long-term research, particularly in diverse global populations, is essential to definitively establish the best possible regimens.

Regimens using vonoprazan (VPZ), amoxicillin (AMX), and sitafloxacin (STFX) have been reported to be effective for the third-line eradication of Helicobacter pylori and are widely used in Japan. However, the outcomes of these therapies have only been reported by a limited number of institutions. We aimed to investigate the backgrounds and treatment outcomes of patients who underwent successful third-line eradication of H. pylori. This was a single-center, retrospective, observational study included patients who underwent antibiotic susceptibility testing and third-line eradication of H. pylori between 2013 and 2020. We examined the success rates of the third-line regimens and compared the backgrounds and clinical characteristics of patients between the successful and failed eradication groups. Fifty-three patients were enrolled. The overall success rate of third-line eradication was 79.2% (42/53 patients). The most commonly used regimens included proton pump inhibitors (PPI) or VPZ, AMX, and STFX (n=43). The success rate of the VPZ, AMX, and STFX regimens was 89.7% (26/29), whereas that of the PPI, AMX, and STFX regimens was 64.3% (9/14). In the comparison between the success and failure groups, the number of female patients (P=0.001) and AMX sensitivity (P=0.028) were significantly higher in the success group than in the failure group. VPZ use and STFX sensitivity were also more common in the successful group, although the differences were not significant. VPZ, AMX, and STFX regimens were the most common and effective regimens, with female and AMX-sensitive patients more likely to have successful third-line eradication.

BackgroundThe real-world comparative effectiveness study aimed to compare the effectiveness of vonoprazan (VON)-based therapy with high-dose esomeprazole (ESO)-based therapy in the re-eradication of Helicobacter pylori.MethodsThis real-world retrospective study analyzed patients at Nanjing First Hospital undergoing H. pylori re-eradication, who received either vonoprazan-based (VON) or high-dose esomeprazole-based (ESO) quadruple therapy. Both regimens included amoxicillin, furazolidone, and bismuth, administered twice daily for 14 days. Treatment strategies were determined by routine clinical practice, using either culture results or local epidemiological data. Patients were further classified into individualized precision (VON-P, ESO-P) or empirical (VON-E, ESO-E) groups based on real-world clinical decision-making.ResultsThe H. pylori re-eradication rates were 89.2% (191/214, 95% CI: 84.4–92.7%) in group ESO and 86.0% (98/114, 95% CI: 78.4–91.2%) in group VON, with no statistically significant difference between groups (P = 0.381). Among patients receiving individualized precision treatment, the re-eradication rates were 87.3% (62/71, 95%CI: 77.6–93.2%) for group ESO-P and 86.9% (53/61, 95% CI: 76.2–93.2%) for group VON-P, with no significant difference observed (P = 0.940). Similarly, for patients undergoing empirical treatment, there was no statistically significant difference in re-eradication rates between group ESO-E and group VON-E (90.2%, 129/143, 95% CI: 84.2–94.1% vs. 84.9%, 45/53, 95% CI: 72.9–92.1%; P = 0.296). Additionally, no significant difference was found between group ESO-E and group ESO-P (90.2%, 129/143, 95% CI: 84.2–94.1% vs. 87.3%, 62/71, 95% CI: 77.6–93.2%; P = 0.521), nor between group VON-E and group VON-P (84.9%, 45/53, 95% CI: 72.9–92.1% vs. 86.9%, 53/61, 76.2–93.2%; P = 0.762).ConclusionsBoth high-dose esomeprazole-containing quadruple therapy and VON-containing quadruple therapy have demonstrated effective as rescue treatments for H. pylori infection. Additionally, antibiotic selection informed by local epidemiological data demonstrated comparable effective to culture-based methods in this cohort, though future large-scale studies are needed to validate its generalizability.

Vonoprazan (VPZ), a potassium-competitive acid blocker, has emerged as an alternative to traditional proton-pump inhibitors like Lansoprazole (LPZ) for the treatment of erosive esophagitis (EE). Vonoprazan provides stronger acid suppression compared to PPIs; however, evidence regarding its effectiveness and safety in treating EE remains limited. We conducted a systematic review and meta-analysis to evaluate the comparative effectiveness and safety of VPZ versus LPZ in the healing and maintenance phases of EE. A comprehensive literature search was conducted across PubMed, Embase and Cochrane Library to identify eligible randomized controlled trials (RCTs) published till 12 December 2024 that evaluated efficacy and safety of VPZ and LPZ in patients with EE. Outcomes included endoscopic healing rates, recurrence rates, and treatment-emergent adverse events (TEAEs). Pairwise meta-analyses and network meta-analyses (NMA) were performed using Review Manager 5.4.1 and Bayesian models. This meta-analysis included 7 RCTs with 4,903 patients. In the healing phase, VPZ showed significantly higher endoscopic healing rates than LPZ at Week 2 (RR: 1.09; 95% CI: 1.04-1.13; p < 0.0001, I2 = 0%) and among patients with severe EE (LA classification C/D) at both Week 2 (RR: 1.26; 95% CI: 1.15-1.38; p < 0.00001, I2 = 0%) and Week 8 (RR: 1.13; 95% CI: 1.03-1.24; p = 0.007, I2 = 67%). No significant differences were observed in TEAEs, severe adverse events, or treatment discontinuation. In the maintenance phase, VPZ 20mg reduced recurrence rates compared to LPZ 15mg (RR: 0.41; 95% CI: 0.17-0.85) without differences in TEAEs. VPZ demonstrates greater efficacy in healing and maintaining remission in EE, particularly in severe cases, with a safety profile comparable to LPZ. These findings support VPZ as an effective alternative to PPIs. However, long-term studies are warranted.

BACKGROUNDHelicobacter pylori (H. pylori) is a Gram-negative bacterium that relies on flagellar motility to colonize the stomach, damaging the gastric mucosa through various mechanisms and leading to various digestive disorders. Accurate assessment and precise treatment are essential in initial intensive therapy.AIMTo investigate the efficacy and safety of a vonoprazan (VPZ)-based triple regimen for first-line eradication of H. pylori in China.METHODSThis multicenter noninferior randomized controlled trial (June 2022 to November 2023) involved 524 H. pylori-positive patients across 19 centers in Shandong, China. Participants were randomized to 14-day esomeprazole/bismuth/amoxicillin/clarithromycin (EBAC), 14-day VPZ/amoxicillin/clarithromycin (VACa), or 10-day VPZ/amoxicillin/clarithromycin (VACb) - all administered twice daily. Primary outcomes (eradication rates) were assessed via intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary endpoints included adverse events and adherence. Noninferiority testing and χ2 tests were used for statistical comparisons.RESULTSA total of 524 patients participated in this study. In ITT analysis, the eradication rates of the EBAC, VACa, and VACb groups were 72.6% (127/175), 88.0% (154/175), and 83.3% (145/174), respectively (P = 0.001). The difference in the eradication rate between the EBAC and VPCa groups was 15.4% [95% confidence interval (CI): 7.3-23.6, P < 0.001], and that between the EBAC and VACb groups was 10.8% (95%CI: 2.1-19.4, P = 0.018). In PP analysis, the eradication rates of the EBAC, VACa, and VACb groups were 81.4% (127/156), 93.9% (154/164), and 90.6% (145/160), respectively (P = 0.001). There was no significant difference in the incidence of adverse reactions among the three groups, which were 36.6%, 33.8% and 29.6%, respectively (P = 0.50).CONCLUSIONVPZ-based triple therapies demonstrate noninferiority to 14-day bismuth-containing regimens, with the 10-day regimen showing comparable efficacy and similar adverse event rates.

Objective: The Smart GeneTM system enables the rapid polymerase chain reaction-based detection of Helicobacter pylori (H. pylori) in gastric juice and determines clarithromycin (CAM) resistance. This study evaluated the clinical utility of the Smart GeneTM system for diagnosing and managing H. pylori infection.Methods: H. pylori diagnosis was obtained using the Smart GeneTM system and the effectiveness of individualized eradication therapy was evaluated. Treatment regimens were chosen based on CAM sensitivity in the Smart GeneTM test.Results: A total of forty-nine patients were assessed. Among them, 28 had H. pylori infection, while 3 had CAM resistance. Seventeen patients underwent H. pylori eradication therapy. Fourteen patients with CAM-sensitive strains underwent eradication therapy with vonoprazan (VPZ), amoxicillin (AMPC), and CAM. Two patients with CAM-resistant strains were treated with VPZ and AMPC, while one received VPZ, AMPC, and metronidazole. The eradication achievement rate was 100%. Of 31 outpatients, 61.5% began H. pylori eradication therapy on the same day as the Smart GeneTM test.Conclusion: Smart GeneTM enables rapid diagnosis of H. pylori infection and the detection of CAM resistance, allowing for personalized eradication regimens.

Introduction: Vonoprazan (VPZ) therapy has become one of the standard treatments for gastroesophageal reflux disease (GERD). When GERD symptoms persist despite the maintenance dose therapy (10 mg daily), dose escalation to 20 mg daily is generally recommended. This study aims to clarify the proper timing and predictors for dose escalation of VPZ therapy in patients with refractory GERD treated with the maintenance dose. Methods: This retrospective observational study included 257 patients with symptomatic GERD. Data from medical records, including endoscopic findings and Izumo scale scores, were analyzed. Results: The mean follow-up period was 3.3 years. Throughout the follow-up period, VPZ dose escalation (from 10 to 20 mg daily) was required in 56 of 257 patients (22%). Kaplan-Meier analysis showed cumulative dose-escalation-free rates at 6 months, 1 year, and 2 years were 87%, 81%, and 78%, respectively. Predictive factors for VPZ dose escalation were analyzed using a Cox proportional-hazards regression model. Multivariate analysis revealed that pre-existing epigastric pain was a significant positive predictor for dose escalation, whereas pre-existing constipation was identified as a significant negative predictor. Kaplan-Meier analysis indicated that the 1-year dose-escalation-free rates were 69% in patients with epigastric pain compared to 88% in those without (p = 0.001). GERD symptom scores showed a significant improvement 1 month after dose escalation. Conclusion: The incidence of refractory GERD requiring VPZ dose escalation is relatively low. Epigastric pain prior to VPZ initiation independently predicts the need for dose escalation. VPZ dose escalation effectively improves GERD symptoms.

Introduction: Vonoprazan (VPZ) is a potent gastric acid secretion inhibitor used to improve the outcomes of Helicobacter pylori (H. pylori) eradication treatments. However, the increasing prevalence of antibiotic-resistant H. pylori strains has limited the efficacy of H. pylori eradication therapies. The aim of this study was to evaluate the efficacy and safety of a 7-day triple therapy with VPZ, amoxicillin (AMOX), and sitafloxacin (STFX) as a third-line H. pylori eradication treatment. Methods: Patients in whom second-line eradication therapy failed were enrolled. The minimum inhibitory concentrations of STFX and AMOX, as well as the gyrA mutation status of H. pylori strains, were determined before treatment. The patients received VPZ (20 mg) twice daily, AMOX (500 mg) four times daily, and STFX (100 mg) twice daily for 7 days (vonoprazan-amoxicillin-sitafloxacin [VAS] group). Successful eradication was evaluated using the 13C-urea breath test. Results: Of the 114 patients enrolled, 75 were treated with the VAS regimen. The overall eradication rate in the VAS group was 90.7% and 94.4% in the intention-to-treat and per-protocol populations, respectively. The VAS regimen completely eradicated gyrA mutation-negative H. pylori strains. Furthermore, it eradicated all strains containing gyrA mutations at position D91. Adverse events were observed in 38.7% of patients, and treatment was discontinued in 1 patient because of eruption, diarrhea, and headache. Conclusion: Overall, the 7-day VAS regimen exhibited an excellent safety profile and efficacy as a third-line eradication treatment, even against gyrA mutation-positive H. pylori strains.

Delayed bleeding is a major concern after gastric endoscopic submucosal dissection (ESD), especially in patients taking antithrombotic agents. The aim of this study was to evaluate the superiority of vonoprazan (VPZ) over proton pump inhibitor (PPI) in preventing delayed bleeding after gastric ESD in patients taking antithrombotic agents. A multicenter, open-label, randomized controlled trial was conducted in 10 Japanese centers. Gastric neoplasm patients taking antiplatelets or anticoagulants were enrolled and randomly allocated in a 1:1 ratio to either the VPZ (20 mg per day for 8 weeks) or the PPI group (esomeprazole 20 mg per day for 8 weeks). Antithrombotic agents were managed according to Japanese guidelines. The primary outcome was the delayed bleeding rate within 8 weeks after ESD. Secondary outcomes included the incidence of symptoms after ESD, healing status of ulcers at 8 weeks, safety, and factors related to delayed bleeding. Of 119 patients (59 in VPZ group, 60 in PPI group), the delayed bleeding rates were 13.6% (8/59) in the VPZ group and 8.3% (5/60) in the PPI group, with no significant difference (p = 0.36). Symptoms and adverse events, the healing status of ulcers at 8 weeks, were comparable between the groups. No use of daily antacids and the combination of antiplatelets and anticoagulants were related to delayed bleeding (odds ratio 13.1 and 34.7, p < 0.01). The present study did not demonstrate the superiority of VPZ over PPIs in preventing delayed bleeding after gastric ESD in patients taking antithrombotic agents. (UMIN000040641/jRCTs041200045).

Despite that the Japanese package insert for vonoprazan (VPZ) includes a precaution that the potassium ion-competitive acid blocker may potentiate the effects of midazolam (MDZ), reports on the actual effects in clinical practice are lacking. Therefore, in this study, we evaluated whether VPZ-taking patients experience clinical effects under MDZ sedation during endoscopy. The participants were outpatients who underwent upper gastrointestinal endoscopy under MDZ anesthesia between April 2021 and April 2022. Comparisons were made between the VPZ(+) and VPZ(-) groups, and the patient background was adjusted using propensity score matching. The post-examination observation time was prolonged in 16.4% of patients in the VPZ(+) group and 13.7% in the VPZ(-) group, but the difference was not statistically significant (p=0.818). The two patients groups also showed no statistically significant differences in the percentage of individuals who received oxygen administration during the examination or in post-examination oxygen saturation and blood pressure values. These results suggest that the use of MDZ for sedation during upper gastrointestinal endoscopy may have minimal clinical effects arising from drug interaction with VPZ.

Objective Proton pump inhibitors (PPIs) are ineffective in suppressing gastric acid secretion after prolonged exposure to an acidic environment in the stomach. In this study, we compared vonoprazan (VPZ) and PPI esomeprazole (EPZ) according to the rate of ulcer scarring after gastric endoscopic submucosal dissection (ESD) in the postoperative stomach, where food residues are often observed, and we investigated their effectiveness in clinical practice. Methods We compared 56 lesions treated with VPZ (20 mg) and 52 lesions treated with EPZ (20 mg) in the postoperative stomach and retrospectively evaluated the scarring rate of post-ESD ulcers at 8 weeks. ESD was performed in our hospital between January 2011 and May 2023. Results The post-ESD ulcer scarring rate after eight weeks was significantly higher in the VPZ group than in the EPZ group (83.9% vs. 57.7%, p<0.01). In the respective groups, the mean age was 72.8 and 70.8 years, food residual rate were 41.1% and 30.8%, the mean resection area was 770.0 and 1,282.4 mm2 (p<0.05), and the postoperative bleeding rates were 5.4% and 7.7%, respectively. There were no significant differences in sex, surgical procedure, diabetes status, or use of steroids, nonsteroidal anti-inflammatory drugs, or antithrombotic medications. An analysis using propensity scores to adjust for age, sex, surgical procedure, and resection area showed a significantly higher scarring rate in the VPZ group (odds ratio 2.65, p<0.05). Conclusion VPZ was associated with a significantly higher scarring rate for post-ESD ulcers in the postoperative stomach than EPZ.

Potassium-competitive acid blocker (P-CAB)-based therapies are emerging as promising alternatives for eradicating Helicobacter pylori infection. However, the comparative efficacy of P-CAB-based therapy versus proton-pump inhibitor (PPI)-based therapy in treating H. pylori infection remains uncertain. This meta-analysis evaluated the efficacy and safety of P-CAB-based therapies, including Vonoprazan (VPZ) and Tegoprazan (TPZ), compared to PPI-based therapies for H. pylori infection. Subgroup analysis assessed the influence of drug history, experimental drug, treatment duration, combination therapies, and geographic regions on treatment outcomes. Meta-analysis. Comprehensive searches were conducted in major databases, including PubMed, Embase, the Cochrane Library, and Web of Science, up to January 1, 2024. The primary outcome was the eradication rate, analyzed by intention-to-treat (ITT). Secondary outcomes included adverse events. Heterogeneity among studies was assessed using the χ2 test and the I 2 test. I 2 > 50% or p < 0.05 indicated significant heterogeneity. The analysis totally included 28 randomized controlled trials (RCTs) comprising 37 studies and 8818 patients diagnosed with H. pylori infection. Of these, 14 RCTs, including 20 studies and 4286 patients, compared P-CAB-based therapy with 14-day bismuth-based quadruple therapy (BQT). P-CAB-based therapy exhibited superior eradication rates compared to both 14-day BQT and PPI-based therapy (ITT analysis: 87.0% vs 79.8%, risk ratio (RR) = 1.08, 95% CI: 1.04-1.12, p < 0.0001; and 85.6% vs 77.8%, RR = 1.09, 95% CI: 1.05-1.12, p < 0.00001, respectively). This enhanced efficacy was particularly pronounced in patients with clarithromycin-resistant infections (73.7% vs 41.5%, RR = 1.53, 95% CI: 1.07-2.20, p = 0.02). Subgroup analysis demonstrated higher eradication rates with P-CAB-based therapy in treatment-naïve participants, VPZ recipients, and those receiving 7- or 14-day regimens (dual, triple, or quadruple therapy). However, no significant differences were observed in treatment-experienced subgroups, TPZ recipients, or those on 10-day regimens. In addition, P-CAB-based therapy showed a lower incidence of adverse events than PPI-based treatments (RR = 0.73, 95% CI: 0.63-0.86, p < 0.0001). P-CAB-based therapies are more effective than traditional PPI-based treatments for eradicating H. pylori infection, with a reduced incidence of adverse events. CRD42024503665.

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. 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. 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. 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. Chinese Clinical trial Registry No. ChiCTR2100055101 31/12/2021.

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.

Chemometric-assisted spectrophotometric methods for simultaneous drug determination in new Helicobacter pylori treatment regimens - Environmental sustainability assessment

Vonoprazan (VPZ) has been shown to have superior acid-inhibitory effects compared to proton pump inhibitors (PPIs). However, there is a paucity of research examining the efficacy of vonoprazan-based bismuth quadruple therapy (VBQT) in the eradication of primary Helicobacter pylori infection. This study aimed to evaluate the effectiveness and safety of VBQT as a first-line treatment for H pylori eradication. This retrospective, real-world, single-arm study included consecutive treatment-naive patients who received VBQT (VPZ 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth potassium citrate 220 mg, all administered twice daily for 14 days) for H pylori eradication between March 1, 2021, and May 30, 2023. The study included both outpatients and inpatients. Eradication rates were assessed using 13C-urea breath tests or 14C-urea breath tests performed 4 to 6 weeks after treatment. The primary outcomes included eradication rates, adverse events, and treatment compliance. A total of 612 H pylori-infected patients were included in the study. The intention-to-treat (ITT), modified ITT (MITT), and per-protocol analyses showed H pylori eradication rates of 84.3% (95% CI: 812% to 87.1%), 95.9% (95% CI: 93.9% to 97.4%), and 96.4% (95% CI: 94.4% to 97.8%), respectively. In the ITT analysis, the adverse event rate was 12.7%, and the treatment compliance rate was 96.9%. In real-world practice, the VBQT regimen demonstrates excellent efficacy and favorable tolerability as a first-line therapy for H pylori eradication.

The 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.