Administration of a standard dose of vonoprazan fumarate delays gastric emptying in Japanese healthy adults: a prospective clinical trial

K, Ota; Takeuchi, Toshihisa; Kojima, Yuichi; Kawaguchi, Shimpei; Iwatsubo, Taro; Hakoda, Akitoshi; Nishida, Shinya; Sasaki, Shun; Kikutani, Satoshi; Tawa, Hideki; Kanaoka, Hideaki; Osaka, Naofumi; Takii, Michiaki; Nakada, Koji; Higuchi, Kazuhide

doi:10.1007/s00535-021-01801-3

Cited by 6 publications

(6 citation statements)

References 34 publications

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“…The results of the present study showed significantly reduced levels of IL-6, IL-8 and TNF-α in patients receiving vonoprazan fumarate tablets vs. those without, suggesting that vonoprazan fumarate tablets effectively alleviate clinical symptoms, promote esophageal mucosal healing and reduce inflammation in the gastric body and sinus of RRE patients. However, whether vonoprazan fumarate tablets have anti-inflammatory effects by non-acid-dependent mechanisms remains to be verified [22] .…”

Section: Resultsmentioning

confidence: 99%

Efficacy of Vonoprazan Fumarate Tablets in Refractory Reflux Esophagitis

Yang¹,

Sun²,

Zhu³

2023

IJPS

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Yang et al.: Efficacy of Vonoprazan Fumarate TabletsTo evaluate the efficacy of vonoprazan fumarate tablets in refractory reflux esophagitis and to provide new insights into the clinical management of refractory reflux esophagitis. A total of 60 refractory reflux esophagitis E patients meeting the inclusion criteria were recruited and assigned via random number table method to receive either conventional treatments (control group) or vonoprazan fumarate plus conventional treatments (treatment group), with 30 cases in each group. Traditional Chinese medicine decoction was administered for adjuvant therapy. Outcome measures included clinical symptom score, gastroesophageal reflux disease healthrelated quality of life scores, esophageal mucosal damage, serum inflammatory factors, serum calcitonin gene related peptide, 5-hydroxytryptamine levels and relapse. Vonoprazan fumarate resulted in milder esophageal mucosal damage and symptoms, and a lower incidence of recurrence vs. conventional treatment alone (p<0.05). Patients with vonoprazan fumarate showed higher quality of life and lower inflammatory factor levels vs. those without (p<0.05). No documented safety events were found during the administration of vonoprazan fumarate. Vonoprazan fumarate tablets are effective in acid suppression, reducing serum calcitonin gene related peptide and 5-hydroxytryptamine levels in refractory reflux esophagitis patients, alleviating the inflammatory response and promoting esophageal mucosal healing with a high safety profile. Vonoprazan fumarate tablets supplemented with traditional Chinese medicine decoction offers a viable option for the treatment of refractory reflux esophagitis. Further studies are required prior to clinical promotion.

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Section: Resultsmentioning

confidence: 99%

Efficacy of Vonoprazan Fumarate Tablets in Refractory Reflux Esophagitis

Yang¹,

Sun²,

Zhu³

2023

IJPS

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“…Other studies have shown that exogenous hypergastrinemia stimulates GE, associated with increased motilin secretion in duodenal acidification [25]. However, a recent study has shown that a 2-week administration of vonoprazan, a newly released P-CAB in Japan, induced hypergastrinemia but did not demonstrate a significant correlation with GE [12]. While this study reported a decrease in liquid GE with vonoprazan, it is important to note that the measurement of GE was performed using liquid food instead of solid food, and the observation period was limited to post-prandial 120 min using breath tests, indicating potential limitations in its methodology.…”

Section: Discussionmentioning

confidence: 96%

“…This biological activity is demonstrated that the first day of 24-h intragastric pH monitoring after administration of tegoprazan 50mg is >4 for 76% of the time and this degree of acid suppression is virtually identical to that achieved (80%) with 14 days of administration [10,11]. In a recent study investigating vonoprazan's effect on GE, serum gastrin levels increased to over 500 pg/dL after 2 weeks of treatment, yet no association with gastric emptying was observed [12]. Furthermore, unlike vonoprazan, tegoprazan induces hypergastrinemia at levels similar to PPIs.…”

Section: Participants and Study Designmentioning

confidence: 95%

Effects of Tegoprazan, Potassium-Competitive Acid Blocker, on the Gastric Emptying and Postprandial Symptoms in Healthy Humans

Lim,

Yoon,

Jung

et al. 2024

Preprint

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Background & Aims: Proton pump inhibitors are potent gastric acid inhibitors. However, they may worsen symptoms such as postprandial fullness and early satiation by reducing gastric emptying (GE). This study aims to evaluate the effects of tegoprazan, a new potassium-competitive acid blocker, on GE and dyspeptic symptoms. Methods: A randomized, double-blind, placebo-controlled design was adopted for this study. Participants underwent GE tests and responded to a questionnaire regarding gastrointestinal symptoms before and after administration of tegoprazan 50 mg. GE was assessed using scintigraphy over 4 hours with a standardized solid meal. Results: Thirty participants were recruited (19 men, mean age 28.2 ± 7.3 years). After medication, no significant differences were observed in gastric half emptying time (T1/2) and gastric retention at 4 hours (GE 4h) between the tegoprazan and the control group (114.2 ± 48.9 min vs. 93.7 ± 34.7 min, P = 0.20; 10.1 ± 12.0% vs. 4.3 ± 5.4%, P = 0.11, respectively). Furthermore, there were no statistically significant differences detected in the changes within each group between two groups (T1/2, 9.9 ± 52.7 min vs.-4.7 ± 30.5 min, P = 0.36; GE 4h, 5.2 ± 13.9% vs.-1.3 ± 6.5%, P = 0.12). The changes in dyspeptic symptom scores after tegoprazan administration did not significantly differ from those in the control group with no correlation between symptoms and GE parameters. Conclusions: In healthy adults, the administration of tegoprazan did not show a significant impact on GE and dyspeptic symptoms, especially postprandial fullness or early satiation.

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“…Low-grade inflammation as shown by eosinophil and mast cell infiltration of the duodenum is associated with functional dyspepsia [1,18] and acid suppression by VPZ may attenuate low-grade inflammation of the duodenum. A recent Japanese study revealed that VPZ delayed gastric emptying but increased ghrelin levels in healthy male subjects [22]. Vonoprazan surely improved dyspepsia symptoms as much as ACO did, and therefore delayed gastric emptying due to VPZ may be compensated by elevating ghrelin levels that can improve dyspepsia symptoms.…”

Section: Discussionmentioning

confidence: 98%

Vonoprazan Therapy is as Effective for Functional Dyspepsia without Heartburn as Acotiamide Therapy

Shinozaki

Osawa

Hayashi

et al. 2023

JGLD

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Background and Aims: Acid suppression improves dyspepsia symptoms but the efficacy of vonoprazan for functional dyspepsia remains unclear. The aim of this study is to evaluate the effectiveness of vonoprazan therapy for functional dyspepsia without heartburn. Methods: Patients receiving vonoprazan 10 mg once daily or acotiamide 100 mg three times daily for more than one month were included and retrospectively reviewed. Functional dyspepsia was diagnosed based on the ROME IV criteria. Patients with heartburn were excluded. Eighty-five patients were divided into vonoprazan (n=48) and acotiamide (n=37) groups. Results: There were no significant differences at baseline between the vonoprazan and acotiamide groups. The functional dyspepsia score significantly improved in both groups (p<0.001). The degree of score reduction (55% vs 59%, p=0.559) and the resolution rates (21% vs 30%, p=0.345) were similar. Epigastric pain and postprandial distress scores were significantly improved in both groups, and the degree of improvement of each score was similar. Constipation and diarrhea scores were significantly improved in both groups, and the degree of improvement similar. Conclusion: These preliminary results suggest that vonoprazan is effective for the treatment of functional dyspepsia without heartburn in the short-term, with results similar to acotiamide therapy.

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Administration of a standard dose of vonoprazan fumarate delays gastric emptying in Japanese healthy adults: a prospective clinical trial

Cited by 6 publications

References 34 publications

Efficacy of Vonoprazan Fumarate Tablets in Refractory Reflux Esophagitis

Efficacy of Vonoprazan Fumarate Tablets in Refractory Reflux Esophagitis

Effects of Tegoprazan, Potassium-Competitive Acid Blocker, on the Gastric Emptying and Postprandial Symptoms in Healthy Humans

Vonoprazan Therapy is as Effective for Functional Dyspepsia without Heartburn as Acotiamide Therapy

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