vonoprazan and Ulcer

Vonoprazan is a potassium competitive acid blocker (P-CAB) approved in Japan in 2014 to treat endoscopic submucosal dissection (ESD)-induced ulcers and bleeding or perforation. Therefore, this meta-analysis aimed to determine whether Vonoprazan is more effective than Lansoprazole in the treatment of ESD-induced ulcers which include ulcer healing and shrinking rate, among others.. Randomized controlled trials (RCT) and retrospective studies were collected from the PubMed (Medline), Embase, Web of science and Cochrane Library databases. Meanwhile, studies were selected according to predetermined qualification criteria and data were extracted by two researchers. The quality of the methods for published papers was evaluated using the modified Jadad scale.. Five studies were included in this meta-analysis, the ulcer healing rate effect was not significantly higher in the intervention groups than in the control groups at 4 weeks, [OR：1.07 (0.51, 2.22), 95% CI, I2=2%, Z=0.18, P=0.86]. There was no significant difference in the ulcer shrinkage rate at 4 weeks [MD：0.20 (-1.51, 1.92), 95% CI, I2=0%, P=0.82] and 8 weeks [MD: -0.09 (-0.30, 0.12), 95% CI, I2=0%, P=0.39].. There was no significant difference between Vonoprazan and Lansoprazole in the ulcers induced by treatment after 4 weeks and 8 weeks of treatment with ESD.

Topics: Endoscopic Mucosal Resection; Humans; Lansoprazole; Proton Pump Inhibitors; Stomach Neoplasms; Stomach Ulcer; Ulcer

Vonoprazan is a potassium-competitive acid blocker (P-CAB) that is frequently used in Japan for Helicobacter pylori (H. pylori) eradication, treatment of gastroesophageal reflux disease, and treatment of post endoscopic submucosal dissection (ESD) complications. We sought to determine if vonoprazan was superior to proton pump inhibitors (PPIs) for treating ESD-induced ulcers (as assessed by ulcer healing and shrinkage ratios) and preventing delayed bleeding over various treatment durations (2, 4, and 8 weeks).. We collected randomized controlled trials (RCTs) and observational studies that discussed the effectiveness of vonoprazan and PPIs on ESD-induced ulcers and bleeding from PubMed, Cochrane Library, ClinicalTrials.gov, and Google Scholar. Studies were selected according to pre-established eligibility criteria and data were extracted separately by 2 researchers with double-check. We used the Cochrane risk of bias tool to assess RCTs and the Newcastle-Ottawa Quality Assessment Scale to assess observational studies. Meta-analyses, based on the random-effects model, were conducted to compare differences in ulcer shrinkage ratios (%) and odds ratios (ORs) for ulcer healing and delayed bleeding. Publication bias was evaluated using funnel plots and Egger regression test. Heterogeneity was assessed using I statistics. A sensitivity analysis was conducted to check the robustness of results. The evidential quality of the findings was assessed using the GRADE profiler.. Thirteen studies were included in this meta-analysis. The OR effect sizes of vonoprazan relative to PPIs for ulcer healing were 1.33 (P = .13) with a 95% CI (0.33-3.21) at 4 weeks and 1.48 (P = .09) with a 95% CI (0.81-5.20) at 8 weeks. The overall effect size for the shrinkage ratio was 12.24% (P = .16) with a 95% CI (-4.96-29.44) at 2 weeks. The effect size of its subgroup of H. pylori-positive patients was 19.51% (P < .001) with a 95% CI (11.91-27.12). The overall OR for the occurrence of delayed bleeding was 0.66 (P = .26) with a 95% CI (0.32-1.35). After excluding combination drug studies, the overall ORs between vonoprazan and PPIs on ulcer healing and delayed bleeding were 1.44 and 0.76, respectively.. During the first 2 weeks of treatment, vonoprazan was more effective than PPIs for treating H. pylori-positive patients with ESD-induced gastric ulcers.

Topics: Adult; Endoscopic Mucosal Resection; Humans; Observational Studies as Topic; Postoperative Complications; Proton Pump Inhibitors; Pyrroles; Randomized Controlled Trials as Topic; Sulfonamides; Ulcer

Vonoprazan, a novel potassium-competitive acid blocking agent, has been used in the management of endoscopic submucosal dissection (ESD)-induced artificial ulcers. This study aimed to perform a systematic review and meta-analysis for the comparison of the effects of vonoprazan and proton pump inhibitors (PPIs) in treating ESD-induced artificial ulcers and preventing delayed bleeding in randomized controlled trial and cohort studies.. We searched OVID-MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, and clinical trial registries in April 2018 to identify all studies that assess and compare the effects of vonoprazan and PPI in treating ESD-induced artificial ulcers and preventing delayed bleeding. Primary outcome of ulcer healing rate and secondary outcomes of shrinkage rate, ulcer size, and delayed bleeding were studied.. A total of 1265 patients from 12 studies were included in the final analysis. Healing rate at 4 weeks post-ESD was significantly higher in the vonoprazan group than in the PPI group (relative ratio [RR] 1.20 [1.03-1.40]). However, healing rate at 8 weeks post-ESD was significantly higher in the PPI group than in the vonoprazan group (RR 0.68 [0.48-0.97]).There was no evidence of significant difference between groups in shrinkage rate at 4 weeks post-ESD, shrinkage rate at 8 weeks post-ESD, delayed bleeding, ulcer size at 0 weeks post-ESD, and ulcer size at 8 weeks post-ESD.. There was no substantial difference in ulcer healing and post-ESD bleeding between vonoprazan and PPIs. However, vonoprazan more rapidly and effectively treated artificial ulcers after ESD than did PPIs.

Topics: Blood Loss, Surgical; Endoscopic Mucosal Resection; Humans; Proton Pump Inhibitors; Pyrroles; Randomized Controlled Trials as Topic; Sulfonamides; Treatment Outcome; Ulcer

Vonoprazan, a potassium-competitive acid blocker (VPZ), significantly reduces postoperative bleeding after gastric ESD; however, there is no consensus on the appropriate treatment duration. We conducted a randomized controlled study to demonstrate that the 3-week administration of VPZ is not inferior to the 8-week administration for ulcer healing.. This is a prospective, open-label multicenter randomized controlled trial. Patients aged 20-85 years undergoing gastric ESD were included in this study. The key exclusion criteria were patients with bleeding tendencies and those taking NSAIDs, steroids, PPIs, or VPZ medications. Eligible patients were randomly assigned to the VPZ 3w or 8w treatment group. The primary endpoint was the proportion of patients with complete closure of the post-ESD wound at 24 weeks after ESD. The key secondary endpoints included the proportion of patients with complete closure of the post-ESD wound at 8 weeks and the proportion of bleeding or perforation more than 3 weeks after ESD.. From May 2018 to October 2020, 234 patients were included. The proportion of patients with complete ulcer closure was significantly lower in the 3w group than in the 8w group (70.8% vs. 90.6%) at 8 weeks post-treatment. The complete closure rates at 24 weeks in the 3w and 8w groups were 99.1% and 99.2%, respectively. The absolute difference in the closure rate at 24 weeks was - 0.059% [95% confidence interval (CI) -3.4% to 3.2], and the lower limit of the 95% CI exceeded -10%, the preset threshold. None of the patients developed delayed bleeding 3 weeks after ESD.. This multicenter randomized study demonstrated that 3 weeks of treatment with VPZ is sufficient for ulcer healing. Trial registry number. UMIN000031564.

Topics: Endoscopic Mucosal Resection; Humans; Prospective Studies; Proton Pump Inhibitors; Stomach Neoplasms; Stomach Ulcer; Treatment Outcome; Ulcer

Endoscopic submucosal dissection (ESD) is a standard procedure for treating gastric neoplasms. However, ESD causes larger artificial ulcers other than mucosal resection methods. We conducted this prospective randomized controlled study to evaluate the effect of stronger acid suppression on ESD ulcers caused by doubling the proton pump inhibitor (PPI) dose and compare the effects of 20-mg (standard dose) and 40-mg (double dose) esomeprazole (EswonampTM, Daewon Pharmaceutical Co., Ltd., Seoul, Korea) on ulcer healing.. One hundred ninety-seven patients who underwent gastric ESD from July 2017 to December 2017 at Pusan National University Yangsan Hospital were enrolled and randomly assigned to the standard or double-dose group. Change in ulcer size from the day of ESD to 4 weeks after ESD and the scar-change rate were compared between the groups.. There were no significant differences in ulcer contraction (84.5% in 20 mg group vs 86.3% in 40 mg group, P = .91) or scar-change rate (30.9% vs 30.6%, P > .99) between the groups. In a multivariate analysis, initial ulcer size [odds ratio (OR) 0.24; 95% confidence interval (CI) 0.11-0.50] and early gastric cancer (OR 0.22, 95% CI 0.08-0.58) were significantly associated with delayed ulcer healing.. Both 40 and 20-mg esomeprazole have similar effects on ESD-induced ulcer area reduction, suggesting that strong acid suppression does not necessarily result in rapid artificial ulcer healing.. RCT no.: KCT0002885.

Topics: Endoscopic Mucosal Resection; Esomeprazole; Female; Humans; Male; Prospective Studies; Proton Pump Inhibitors; Pyrroles; Republic of Korea; Stomach Neoplasms; Stomach Ulcer; Sulfonamides; Ulcer; Wound Healing

Topics: Bosentan; Chemical and Drug Induced Liver Injury; Drug Interactions; Esophagitis, Peptic; Humans; Pharmaceutical Preparations; Pyrroles; Scleroderma, Systemic; Sulfonamides; Ulcer