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Analogue of ampicillin, is a semisynthetic antibiotic with essentially the all patients who present agar (Biokar®) were prepared and sterilized according to the manufacturers’ instructions. Another drug and may not reflect the rates.

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02.11.2015

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The eradication rates of VA-dual and VAC-triple therapies were 84.5% and 89.2% (

p=0

.203) by

intention-to-treat

analysis, respectively, and 87.1% and 90.2% (p=0.372) by per-protocol analysis, respectively.

VA-dual was non-inferior to VAC-triple in the per-protocol analysis.

The eradication rates in strains resistant to clarithromycin for VA-dual were significantly higher than those for VAC-triple (92.3% vs 76.2%; p=0.048). The incidence of adverse events was equal between groups.

Conclusion The 7-day vonoprazan and low-dose amoxicillin dual therapy provided acceptable H. pylori eradication rates and a similar effect to vonoprazan-based triple therapy in regions with high clarithromycin resistance.

helicobacter pylori - treatment antibiotics - clinical trials gastric inflammation clinical trials. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. helicobacter pylori - treatment antibiotics - clinical trials gastric inflammation clinical trials.

Macrolides, including clarithromycin, readily induce changes in the resistome of Helicobacter pylori, and the clarithromycin resistance of H.

Usage of clarithromycin should be discontinued as an empirical treatment in wide-scale strategies for H.

Vonoprazan strongly inhibits gastric acid secretion, and vonoprazan-based triple therapy (VAC-triple) achieves sufficient eradication rates and high safety.

Vonoprazan and low-dose amoxicillin dual therapy for 7 days (VA-dual) is a regimen with minimal usage of antibiotics and is simpler than current H.

VA-dual achieved acceptable eradication rates of 85% in intention-to-treat and 87% in per-protocol analyses.

VA-dual achieved an eradication rate of over 85% for both clarithromycin-susceptible and clarithromycin-resistant strains, and achieved a higher eradication rate than VAC-triple against clarithromycin-resistant strains.

How might it impact on clinical practice in the foreseeable future? In the era of growing antimicrobial resistance, VA-dual is a potential new first-line H.

pylori therapy for cases of high clarithromycin resistance because it provides an acceptable eradication rate and high safety, and will have a potentially less negative impact on future antimicrobial resistance of H. Helicobacter pylori infection is common chronic bacterial infections in humans, affecting approximately 50% of the global population.1 Although the prevalence of H. pylori is generally declining, the prevalence of the infection and the reinfection rates remain high in several regions.2 As H. pylori infection causes gastritis, peptic ulcer disease, mucosal-associated lymphoid tissue and gastric cancer, H. pylori eradication treatment is performed worldwide to improve and reduce these conditions.3–5.

pylori treatment has decreased owing to increasing its antimicrobial resistance.

Recent international guidelines recommend four-drug combination therapies containing 2–3 kinds of antibiotics for 10–14 days as the first-line treatment for H. pylori in regions with high clarithromycin (CLA) resistance to overcome its antimicrobial resistance.6–8 However, these quadruple regimens have several disadvantages, including severe side effects, high cost and low compliance due to the use of multiple antibiotic agents for a long period; these features have hampered its implementation in routine clinical practice. Furthermore, the use of multiple

antibiotic

agents in H. pylori treatment can increase the risk of future antimicrobial resistance.

Thus, novel regimens and approaches enabling minimal antibiotic usage and shorter treatment duration are required to prevent antimicrobial resistance while achieving sufficient eradication rates. Dual therapy composed of a proton-pump inhibitor (PPI) and amoxicillin (AMO) is the simplest regimen for H. pylori treatment and, because it is a single antibiotic therapy, we expect it will not contribute to the development of H. Maintaining a near-neutral pH in the stomach during eradication therapy is important to succeed dual therapy regimen.

Vonoprazan, a novel potassium-competitive acid blocker, provides a stronger and longer-lasting effect on the gastric acid suppression than other PPIs.9 Therefore, vonoprazan is expected to be more effective than other PPIs when used in dual therapy with AMO for the H.

pylori eradication has not been studied yet and no randomised studies have assessed the efficacy of dual therapy consisting of vonoprazan and AMO for H. The aim of this proof of concept study was to evaluate the efficacy

and

tolerability of the 7-day vonoprazan and low-dose AMO dual therapy (VA-dual) and to compare it with a 7-day vonoprazan, AMO and CLA triple therapy (VAC-triple) as the first-line treatments for H. This study was designed as a multicentre, open-label, randomised controlled trial. This study was conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials (CONSORT).

This study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (www.umin.ac.jp/ctr/) on 14 September 2018.

Consecutive patients who underwent oesophagogastroduodenoscopy to evaluate the cause of any abdominal symptom or screening for upper GI cancer were recruited in seven institutions in Japan between October 2018 and June 2019.

All the 629 recruited patients were screened and underwent H. pylori culture test through biopsy of the gastric mucosa.

Patients were eligible if they were aged 20–79 years and had confirmed H.

Patients were excluded if they had any of the following: history of receiving H. pylori eradication therapy; allergy to any of the study drugs; history of gastric surgery; use of PPIs, antibiotics or steroids that could not have been discontinued during this study; pregnancy or breast feeding; lack of informed consent.



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