Vonoprazan versus lansoprazole in the treatment of artificial gastric ulcers after endoscopic submucossal dissection: a randomized, open-label trial

Xie

Clinical Translational Sci

et al. 2023

Keverprazan, a novel potassium‐competitive acid blocker, was approved for treating acid‐related diseases. This study aimed to analyze the safety, pharmacokinetics (PKs) and pharmacodynamics (PDs) of multiple doses of keverprazan. This was a randomized, positive‐/placebo‐controlled, phase Ic trial. Twenty‐six healthy adults were randomized to receive 20 mg/day keverprazan (n = 8), 40 mg/day keverprazan (n = 8), placebo (n = 6), or 20 mg/day vonoprazan (n = 4) for 7 days. Safety, PK and PD assessments were conducted. In the keverprazan, vonoprazan, and placebo groups, adverse events (AEs) were reported in nine (56.25%), two (50.00%), and three (50.00%) subjects, respectively. AEs were mild except a moderate abdominal pain leading to withdraw. No serious AEs occurred. The plasma concentration‐time profiles of keverprazan showed rapid absorption (median time to maximum plasma concentration of 1.25–3.0 h). The terminal half‐life was 6.23 and 7.01 h for keverprazan 20 and 40 mg groups on day 7. The maximum plasma concentration was 43.1 and 93.2 ng/mL, respectively. There was no apparent accumulation of keverprazan and the major metabolite after 7‐day administration. The intragastric pH greater than 5 holding time ratios (HTRs) over 24 h postdose increased from 79.1%, 84.4%, and 84.5% on day 1 to 99.0%, 97.4%, and 100.0% on day 7 in the vonoprazan 20 mg and keverprazan 20 and 40 mg groups, respectively. The intragastric pH greater than 5 HTR of keverprazan reached a plateau at 20 mg. Keverprazan is well‐tolerable. A steady‐state in exposure was generally reached after 7 days of treatment. A dose of 20 mg/day keverprazan can elicit a significant, stable, and long‐lasting gastric acid inhibition effect.

Section: Discussionmentioning

confidence: 59%

“…Moreover, the categories of the AEs for keverprazan were similar to other P‐CABs. 11 , 12 , 16 , 17 , 21 , 22 , 23 , 24 , 25 , 26 , 27 No new safety signals appeared. The small number of participants might preclude the observation of rare AEs.…”

Section: Discussionmentioning

confidence: 99%

Keverprazan, a novel potassium‐competitive acid blocker: Multiple oral doses safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects

Xie

Clinical Translational Sci

et al. 2023

“…This result was similar to a recent study comparing the efficacy of vonoprazan and lansoprazole treatment for artificial ulcers. 19 We strictly interpreted the ulcer stages and even minute ulcer bases were classified as healing stages. Additionally, the shrinkage rates of artificial ulcers should not be misinterpreted as complete healing.…”

Section: Discussionmentioning

confidence: 99%

The Effect of Tegoprazan on the Treatment of Endoscopic Resection-Induced Artificial Ulcers: A Multicenter, Randomized, Active-Controlled Study

Kim,

Park,

Moon

et al. 2024

Gut and Liver

Background/Aims Tegoprazan is a novel potassium-competitive acid blocker that has beneficial effects on acid-related disorders such as gastroesophageal reflux and peptic ulcer diseases. This study aimed to validate the effect of tegoprazan on endoscopic submucosal dissection (ESD)-induced artificial ulcers. Methods Patients from 16 centers in Korea who underwent ESD for gastric neoplasia were enrolled. After ESD, pantoprazole was administered intravenously for 48 hours. The patients were randomly allocated to either the tegoprazan or esomeprazole group. Tegoprazan 50 mg or esomeprazole 40 mg were administered for 4 weeks, after which gastroscopic evaluation was performed. If the artificial ulcer had not healed, the same dose of tegoprazan or esomeprazole was administered for an additional 4 weeks, and a gastroscopic evaluation was performed. Results One hundred sixty patients were enrolled in this study. The healing rates of artificial ulcers at 4 weeks were 30.3% (23/76) and 22.1% (15/68) in the tegoprazan and esomeprazole groups, respectively (p=0.006). At 8 weeks after ESD, the cumulative ulcer healing rates were 73.7% (56/76) and 77.9% (53/68) in the tegoprazan and esomeprazole groups, respectively (p=0.210). Delayed bleeding occurred in two patients in the tegoprazan group (2.6%) and in one patient in the esomeprazole group (1.5%). Other adverse events were negligible in both groups. Conclusions Tegoprazan showed similar effects on post-ESD artificial ulcer healing in comparison with esomeprazole.

“…A. Hirai et al compared the effects of vonoprazan 20 mg and lansoprazole 30 mg in treating post-ESD ulcers and found that both drugs had similar efficacy [27]. D. Kawai et al similarly reported that vonoprazan may not be a better choice than lansoprazole in ulcer healing after ESD; furthermore, the 4-week ulcer healing rate was not significantly higher in either group [28]. H. Komori et al proved that vonoprazan is not more effective than rabeprazole -when using rabeprazole at a dose of 10 mg, ulcer healing after endoscopic submucosal dissection was faster than with vonoprazan 20 mg [29].…”

Section: Vonoprazan and Endoscopic Submucosal Dissection (Esd)mentioning

confidence: 99%

Vonoprazan - a new drug for inhibiting gastric acid secretion

Niewęgłowski

Wilczek

Rycharski³

et al. 2022

J Educ Health Sport

Introduction and purpose Vonoprazan is a potassium-competent acid blocker (P-CAB). It has the potential to be an alternative to proton pump inhibitors (PPIs) as it inhibits hydrochloric acid secretion. The mechanism of action is different than PPIs - vonoprazan reversibly inhibits gastric H+, K+-ATPase, while PPIs irreversibly. Vonoprazan is approved for use in Japan and the US. The aim of the study was to review articles on the use of vonoprazan instead of PPIs in the treatment of acid-related gastrological diseases and to present the results obtained. A brief description of the state of knowledge Vonoprazan is used in the treatment of acid-related gastrological diseases. The 20 mg dose is suitable for most diseases, such as treatment of ulcers during low-dose aspirin treatment, post-endoscopic submucosal dissection (post-ESD) ulcers, erosive esophagitis (EE) in gastroesophageal reflux disease (GERD), and Helicobacter pylori eradication. Summary Researches suggest that the drug is an alternative for PPIs and can be used instead of them. The main advantage of this drug over PPIs is that it works faster, more potent and long-lasting. Studies suggest that vonoprazan can be use to treatment of the acid-related diseases and may be a better choice than PPIs. Vonoprazan may have a particular use in the treatment of PPI-refractory GERD. In post-ESD ulcers, a significant benefit in treatment effects of vonoprazan over PPIs cannot be clearly concluded.