Acid‐inhibitory effects of vonoprazan 20 mg compared with esomeprazole 20 mg or rabeprazole 10 mg in healthy adult male subjects ‐ a randomised open‐label cross‐over study. Issue 6 (21st July 2015)

• Record Type: Journal Article
• Authors: Sakurai, Y.; Mori, Y.; Okamoto, H.; Nishimura, A.; Komura, E.; Araki, T.; Shiramoto, M.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 42:Issue 6(2015)
• Page Start: 719
• Page End: 730
• Publication Date: 2015-07-21
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.13325
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt13325-abs-0001"> <title>Summary</title> <sec id="apt13325-sec-0001" sec-type="section"> <title>Background</title> <p>Proton pump inhibitors (PPIs) are widely used for the treatment of acid‐related diseases. Vonoprazan is a member of a new class of acid suppressants; potassium‐competitive acid blockers. Vonoprazan may thus be an alternative to PPIs.</p> </sec> <sec id="apt13325-sec-0002" sec-type="section"> <title>Aim</title> <p>To evaluate efficacy, rapidity and duration of acid‐inhibitory effects of vonoprazan vs. two control PPIs, esomeprazole and rabeprazole, in 20 healthy Japanese adult male volunteers with CYP2C19 extensive metaboliser genotype.</p> </sec> <sec id="apt13325-sec-0003" sec-type="section"> <title>Methods</title> <p>In this randomised, open‐label, two‐period cross‐over study, vonoprazan 20 mg and esomeprazole 20 mg (Study V vs. E) or rabeprazole 10 mg (Study V vs. R) were orally administered daily for 7 days. Primary pharmacodynamic endpoint was gastric pH over 24 h measured as percentage of time pH ≥3, ≥4 and ≥5 (pH holding time ratios; HTRs) and mean gastric pH.</p> </sec> <sec id="apt13325-sec-0004" sec-type="section"> <title>Results</title> <p>Acid‐inhibitory effect (pH4 HTR) of vonoprazan was significantly greater than that of esomeprazole or rabeprazole on both Days 1 and 7; Day 7 difference in pH4 HTR for vonoprazan vs. esomeprazole was 24.6% [95% confidence interval (CI): 16.2–33.1] and for vonoprazan vs. rabeprazole 28.8% [95% CI: 17.2–40.4]. The Day 1 to Day 7 ratio of 24‐h pH4 HTRs was >0.8 for vonoprazan, compared with 0.370 for esomeprazole and 0.393 for rabeprazole. Vonoprazan was generally well tolerated. One vonoprazan subject withdrew due to a rash which resolved after discontinuation.</p> </sec> <sec id="apt13325-sec-0005" sec-type="section"> <title>Conclusions</title> <p>This study demonstrated a more rapid and sustained acid‐inhibitory effect of vonoprazan 20 mg vs. esomeprazole 20 mg or rabeprazole 10 mg. Therefore, vonoprazan may be a potentially new treatment for acid‐related diseases.</p> </sec> </abstract>