Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study)

Takeuchi, Toshihisa; Furuta, Takahisa; Fujiwara, Yasuhiro; Sugimoto, Mitsushige; Kasugai, Kunio; Kusano, Motoyasu; Okada, Hiroyuki; Suzuki, Takahiro; Higuchi, Tomohiro; Kagami, Takuma; Uotani, Takahiro; Yamade, Mihoko; Tanaka, Fumio; Harada, Satoshi; K, Ota; Kojima, Yuichi; Murata, Masaki; Tamura, Yasuhiro; Funaki, Yasushi; Kawamura, Osamu; Okamoto, Yuki; Fujimoto, Kazuma; Higuchi, Kazuhide

doi:10.1111/apt.15641

Cited by 40 publications

(46 citation statements)

References 41 publications

(76 reference statements)

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“…In spite of the noble objectives and obvious pathophysiological arguments, non-variceal upper GI bleeding has, to date, not been the focus of development for vonoprazan nor tegoprazan. Planning and undertaking studies in the management of acute upper GI bleeding present a considerable challenge but the superiority of oral vonoprazan on pH holding times when compared with esomeprazole and rabeprazole is clearly evident [29,31,208]. These three studies reported similar results comparing esomeprazole and/or rabeprazole with vonoprazan.…”

Section: Vonoprazan Efficacy In the Treatment Of Peptic Ulcermentioning

confidence: 82%

“…None of the studies reported data for pH 6, although the 24-h intragastric pH curves from one [31] of the studies suggest that the results would, at least, be similar. In the SAMURAI pH study [208], the data reported for the pH 5 HTR for the cohort of healthy Japanese volunteers taking vonoprazan (20 mg once daily) versus rabeprazole (20 mg once daily) were (mean and SD) 80.9% (16.3) versus 38.1% (16.8), respectively. The treatment difference (LS mean and 95% CI) was 42.7% (28.3-57.2, pG0.0001).…”

Section: Vonoprazan Efficacy In the Treatment Of Peptic Ulcermentioning

confidence: 99%

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Acid Suppressant Therapy: a Step Forward with Potassium-Competitive Acid Blockers

Scarpignato

Hunt

2021

Curr Treat Options Gastro

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Purpose of the review The introduction of H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) into clinical practice has been a real breakthrough in the treatment of acid-related diseases. PPIs are now the standard of care for the treatment of gastroesophageal reflux disease (GERD), peptic ulcer disease (PUD), Helicobacter pylori infection, NSAID-associated gastroduodenal lesions, and upper gastrointestinal bleeding (UGIB). However, despite their effectiveness, PPIs display some intrinsic limitations, which underlie the unmet clinical needs that have been identified over the past decades. Recent findings To address these needs, new long-acting compounds (such as tenatoprazole and AGN 201904-Z) and new PPI formulations, including instant release omeprazole (IR-omeprazole) and dexlansoprazole modified release (MR), have been developed. However, a major advance has been the development of the potassium-competitive acid blockers (P-CABs), which block the K+,H+-ATPase potassium channel, are food independent, are reversible, have a rapid onset of action, and maintain a prolonged and consistent elevation of intragastric pH. Vonoprazan and tegoprazan are the two marketed P-CABs while two other compounds (namely fexuprazan and X842) are under active development. Available for almost 6 years now, a considerable experience has been accumulated with vonoprazan, the efficacy and safety of which are detailed in this paper, together with the preliminary results of the other members of this new pharmacologic class. Summary Based on the available evidence, erosive reflux disease, H. pylori infection, and secondary prevention of NSAID gastropathy can be considered established indications for vonoprazan and are being explored for tegoprazan and fexuprazan. In the treatment of severe (LA C & D) reflux esophagitis and H. pylori eradication, vonoprazan proved to be superior to PPIs. Other uses of P-CABs are being evaluated, but clinical data are not yet sufficient to allow a definitive answer on its efficacy and possible superiority over the current standard of care (i.e., PPIs). The most notable indication of upper GI (non-variceal) bleeding, where vonoprazan would prove superior to PPIs, has not yet been explored. The safety of P-CABs in the short-term overlaps that of PPIs, but data from long-term treatment are needed.

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Section: Vonoprazan Efficacy In the Treatment Of Peptic Ulcermentioning

confidence: 82%

Section: Vonoprazan Efficacy In the Treatment Of Peptic Ulcermentioning

confidence: 99%

Acid Suppressant Therapy: a Step Forward with Potassium-Competitive Acid Blockers

Scarpignato

Hunt

2021

Curr Treat Options Gastro

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“…Patients with extensive metabolism of the CYP2C19 genotype have a higher risk of PPI-resistant reflux esophagitis than those with poor metabolism (29); the acid suppression effect of vonoprazan is not influenced by the CYP2C19 genotype (5). An open-label cross-over study showed significantly superior acid suppression by vonoprazan compared with rabeprazole, and the pH4 holding time ratios were 88.4 and 53.8% in patients treated with 20 mg vonoprazan and 20 mg rabeprazole, respectively (30). A Japanese randomized controlled trial showed improved pH4 holding times following 8 weeks of 20 mg and 40 mg vonoprazan therapy for PPI-resistant erosive GERD (9).…”

Section: Discussionmentioning

confidence: 95%

Long‑term vonoprazan therapy is effective for controlling symptomatic proton pump inhibitor‑resistant gastroesophageal reflux disease

Shinozaki¹,

Osawa

Hayashi

et al. 2021

Biomed Rep

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Vonoprazan, a novel potassium-competitive acid blocker, results in greater inhibition of gastric acid secretion than proton pump inhibitors (PPI). The aim of this study was to assess the long-term outcomes of patients with PPI-resistant gastroesophageal reflux disease (GERD) treated with vonoprazan. The medical records of patients with symptomatic GERD treated with vonoprazan for 1 year were retrospectively reviewed. Changes in abdominal symptoms were assessed using the Izumo scale, a self-reported questionnaire which is useful in evaluating the symptoms of GERD, epigastric pain, postprandial distress, constipation and diarrhea, and is commonly used in routine clinical practice. A total of 30 patients were included and stratified into a non-erosive (n=22) and erosive group (n=8). At baseline, postprandial distress symptoms were significantly greater in the non-erosive group compared with the erosive group (P= 0.013). Even with vonoprazan therapy, symptoms of GERD in the non-erosive group were refractory compared with the erosive group, and required additional treatment in a larger proportion of patients (45 vs. 13%). GERD symptoms in the non-erosive group significantly improved from baseline and remained better after 1 year of vonoprazan therapy, similar to the erosive group. In addition, vonoprazan improved epigastric pain and postprandial distress symptoms in the non-erosive group, and 1 year of vonoprazan therapy did not aggravate constipation or diarrhea. In conclusion, 1 year of vonoprazan therapy improves GERD symptoms in patients with PPI-resistant GERD.

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“…24-h impedance-pH monitoring of available 17 Japanese healthy volunteers (HVs) were re-analyzed [ 16 ] and the prevalence of SGB was compared with data published from 40 healthy subjects in the UK [ 17 ]. Healthy subjects did not have gastro-intestinal (GI) symptoms or history of upper GI surgery.…”

Section: Methodsmentioning

confidence: 99%

Supragastric belching in Japan: lower prevalence and relevance for management of gastroesophageal reflux disease compared to United Kingdom

et al. 2020

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Background Supragastric belching (SGB) may play a role in the pathophysiology of proton pump inhibitors (PPIs)-refractoriness in gastroesophageal reflux disease (GERD). SGB may be present in up to 40% of reflux symptoms in PPI-refractory GERD. Most reports on SGB have come from Western countries, and little is known about the prevalence and relevance of SGB in Asian refractory GERD patients. This study aimed at comparing the role of SGB in GERD patients in Japan and the UK. Methods We re-analyzed impedance-pH monitoring tracings from patients who were referred to tertiary centers in Japan and the UK due to PPI-refractory reflux symptoms. The prevalence of excessive SGB and the impact of SGB on reflux symptoms were compared between the two countries. Results Impedance-pH tracings from124 Japanese and 83 British patients were re-analyzed. Japanese patients were significantly younger and had smaller body mass index than the British (P < 0.001). Japanese patients had significantly lower prevalence of excessive SGB (18.5%) than the UK (36.1%) irrespective of reflux phenotype (P = 0.006). Logistic regression analysis showed that the geographical/cultural difference was the only factor associated with the different prevalence of SGB (odds ratio; 2.91, 95% CI 1.09–7.73, P = 0.032). SGB were related to typical reflux symptoms very rarely in Japan [0% (0–4.9)] compared to the UK [35% (0–54.1)] (P = 0.071). Conclusions The prevalence of SGB and their impact on reflux symptoms is significantly lower in Japan compared to the UK. The difference is not related to reflux parameters but might come from ethnic/cultural factors to be further characterized.

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Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study)

Cited by 40 publications

References 41 publications

Acid Suppressant Therapy: a Step Forward with Potassium-Competitive Acid Blockers

Acid Suppressant Therapy: a Step Forward with Potassium-Competitive Acid Blockers

Long‑term vonoprazan therapy is effective for controlling symptomatic proton pump inhibitor‑resistant gastroesophageal reflux disease

Supragastric belching in Japan: lower prevalence and relevance for management of gastroesophageal reflux disease compared to United Kingdom

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