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Seven-Day Vonoprazan and Low-Dose Amoxicillin Dual Therapy As First-Line

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Seven-Day Vonoprazan and Low-Dose Amoxicillin Dual Therapy As First-Line Helicobacter pylori ORIGINAL RESEARCH Gut: first published as 10.1136/gutjnl-2019-319954 on 8 January 2020. Downloaded from Seven- day vonoprazan and low- dose amoxicillin dual therapy as first- line Helicobacter pylori treatment: a multicentre randomised trial in Japan Sho Suzuki ,1,2 Takuji Gotoda ,1 Chika Kusano,1 Hisatomo Ikehara,1 Ryoji Ichijima,1 Motoki Ohyauchi,3 Hirotaka Ito,3 Masashi Kawamura,4 Yohei Ogata,4 Masahiko Ohtaka,5 Moriyasu Nakahara,6 Koichi Kawabe7 1Division of Gastroenterology ABSTRact and Hepatology, Department Objective To date, no randomised trials have compared Significance of this study of Medicine, Nihon University the efficacy of vonoprazan and amoxicillin dual therapy School of Medicine, Tokyo, What is already known on this subject? Japan with other standard regimens for Helicobacter pylori 2Department of treatment. This study aimed to investigate the efficacy ► Macrolides, including clarithromycin, readily Gastroenterology, Yuri Kumiai of the 7- day vonoprazan and low- dose amoxicillin dual induce changes in the resistome of Helicobacter General Hospital, Yurihonjo, therapy as a first-line H. pylori treatment, and compared pylori, and the clarithromycin resistance of H. Akita, Japan pylori is high and increasing worldwide. 3Department of this with vonoprazan-based triple therapy. Gastroenterology, Osaki Citizen Design This prospective, randomised clinical trial ► Usage of clarithromycin should be discontinued Hospital, Osaki, Miyagi, Japan was performed at seven Japanese institutions. Patients as an empirical treatment in wide-scale 4 Department of with H. pylori–positive culture test and naive to strategies for H. pylori infection. Gastroenterology, Sendai City ► Vonoprazan strongly inhibits gastric acid Hospital, Sendai, Miyagi, Japan treatment were randomly assigned in a 1:1 ratio to 5 secretion, and vonoprazan-based triple therapy Yamanashi Koseiren Health either VA-dual therapy (vonoprazan 20 mg+amoxicillin Care Center, Kofu, Yamanashi, 750 mg twice/day) or VAC-triple therapy (vonoprazan (VAC- triple) achieves sufficient eradication rates Japan and high safety. 6 20 mg+amoxicillin 750 mg+clarithromycin 200 mg twice/ Department of day) for 7 days, with stratification by age, sex, H. pylori Gastroenterology, Chichibu What are the new findings? Municipal Hospital, Chichibu, antimicrobial resistance and institution. Eradication 13 ► Vonoprazan and low- dose amoxicillin dual Saitama, Japan success was evaluated by C- urea breath test at least 4 7 therapy for 7 days (VA-dual) is a regimen with Department of weeks after treatment. minimal usage of antibiotics and is simpler than http://gut.bmj.com/ Gastroenterology, Fukaya Red Results Between October 2018 and June 2019, 629 Cross Hospital, Fukaya, Saitama, current H. pylori therapies. Japan subjects were screened and 335 were randomised. The ► VA- dual achieved acceptable eradication rates eradication rates of VA-dual and VAC-triple therapies of 85% in intention-to- treat and 87% in per- Correspondence to were 84.5% and 89.2% (p=0.203) by intention- to- treat protocol analyses. Professor Takuji Gotoda, analysis, respectively, and 87.1% and 90.2% (p=0.372) ► VA- dual achieved an eradication rate of over Division of Gastroenterology by per-protocol analysis, respectively. VA-dual was non- 85% for both clarithromycin-susceptible and and Hepatology, Department inferior to VAC-triple in the per-protocol analysis. The on September 30, 2021 by guest. Protected copyright. of Medicine, Nihon University clarithromycin- resistant strains, and achieved a School of Medicine, Tokyo 101- eradication rates in strains resistant to clarithromycin higher eradication rate than VAC-triple against 8309, Japan; for VA-dual were significantly higher than those for clarithromycin- resistant strains. takujigotoda@ yahoo. co. jp VAC- triple (92.3% vs 76.2%; p=0.048). The incidence of adverse events was equal between groups. How might it impact on clinical practice in the Received 27 September 2019 foreseeable future? Revised 4 December 2019 Conclusion The 7-day vonoprazan and low-dose Accepted 25 December 2019 amoxicillin dual therapy provided acceptable H. pylori ► In the era of growing antimicrobial resistance, eradication rates and a similar effect to vonoprazan- VA- dual is a potential new first- line H. pylori based triple therapy in regions with high clarithromycin therapy for cases of high clarithromycin resistance. resistance because it provides an acceptable Trial registration number UMIN000034140. eradication rate and high safety, and will have a potentially less negative impact on future © Author(s) (or their antimicrobial resistance of H. pylori. employer(s)) 2020. Re- use permitted under CC BY-­NC. No INTRODUCTION commercial re- use. See rights and permissions. Published Helicobacter pylori infection is common chronic pylori eradication treatment is performed world- 3–5 by BMJ. bacterial infections in humans, affecting approxi- wide to improve and reduce these conditions. mately 50% of the global population.1 Although the The eradication effect of H. pylori treatment To cite: Suzuki S, Gotoda T, prevalence of H. pylori is generally declining, the has decreased owing to increasing its antimicrobial Kusano C, et al. Gut Epub ahead of print: [please prevalence of the infection and the reinfection rates resistance. Recent international guidelines recom- 2 include Day Month Year]. remain high in several regions. As H. pylori infec- mend four- drug combination therapies containing doi:10.1136/ tion causes gastritis, peptic ulcer disease, mucosal- 2–3 kinds of antibiotics for 10–14 days as the first- gutjnl-2019-319954 associated lymphoid tissue and gastric cancer, H. line treatment for H. pylori in regions with high Suzuki S, et al. Gut 2020;0:1–8. doi:10.1136/gutjnl-2019-319954 1 Helicobacter pylori clarithromycin (CLA) resistance to overcome its antimicrobial CO2, 5% O2) at 37℃ for 7–10 days. The culture was considered 6–8 resistance. However, these quadruple regimens have several positive if one or more colonies showed Gram negativity, urease, Gut: first published as 10.1136/gutjnl-2019-319954 on 8 January 2020. Downloaded from disadvantages, including severe side effects, high cost and low oxidase, catalase, and spiral or curved rods in morphology. compliance due to the use of multiple antibiotic agents for a Antimicrobial susceptibility of H. pylori isolates was deter- long period; these features have hampered its implementation in mined by the microbroth dilution method using Eiken Chem- routine clinical practice. Furthermore, the use of multiple antibi- ical dry plates (Eiken Chemical, Tokyo, Japan). Each well of a otic agents in H. pylori treatment can increase the risk of future 96-well microplate was coated with twofold serial dilutions of antimicrobial resistance. Thus, novel regimens and approaches AMO and CLA and air- dried. A saline suspension of the test enabling minimal antibiotic usage and shorter treatment dura- strain was added to each well, and the cultures were incubated at tion are required to prevent antimicrobial resistance while 35℃ for 3 days in a microaerophilic atmosphere (O2, 10%; CO2, achieving sufficient eradication rates. 5%). The minimal inhibitory concentration (MIC) was defined Dual therapy composed of a proton- pump inhibitor (PPI) and as the lowest concentration of a test antibiotic that completely amoxicillin (AMO) is the simplest regimen for H. pylori treat- inhibited visible bacterial growth. MIC values of ≥0.12 µg/mL ment and, because it is a single antibiotic therapy, we expect for AMO and ≥1 µg/mL for CLA were defined as resistance it will not contribute to the development of H. pylori antibi- break points. otic resistance. Maintaining a near- neutral pH in the stomach during eradication therapy is important to succeed dual therapy regimen. Vonoprazan, a novel potassium-competitive acid Randomisation and trial intervention blocker, provides a stronger and longer- lasting effect on the The 335 eligible patients were randomly assigned to receive gastric acid suppression than other PPIs.9 Therefore, vonoprazan either VA- dual or VAC- triple in a 1:1 allocation ratio. VA- dual is expected to be more effective than other PPIs when used in consisted of 20 mg vonoprazan (Takeda Pharmaceutical, Tokyo, dual therapy with AMO for the H. pylori eradication treatment. Japan) twice daily and 750 mg AMO twice daily for 7 days. The However, the efficacy of such dual therapy for H. pylori eradi- VAC- triple consisted of 20 mg vonoprazan twice daily, 750 mg cation has not been studied yet and no randomised studies have AMO twice daily and 200 mg CLA twice daily for 7 days. AMO assessed the efficacy of dual therapy consisting of vonoprazan and CLA used in both therapies were from Takeda Pharmaceu- and AMO for H. pylori eradication. tical or of generic branding. The treatment group was randomly The aim of this proof of concept study was to evaluate the assigned by the UMIN Medical Research Support INDICE Cloud efficacy and tolerability of the 7- day vonoprazan and low- dose System. Randomisation was performed by dynamic balancing AMO dual therapy (VA-dual) and to compare it with a 7- day using the minimisation method, with stratification by age (<60 vonoprazan, AMO and CLA triple therapy (VAC- triple) as the years vs ≥60 years), sex (male vs female), AMO resistance of H. first- line treatments for H. pylori. pylori (MIC <0.12 µg/mL vs MIC ≥0.12 µg/mL), CLA resistance of H. pylori (MIC <1 µg/mL vs MIC ≥1 µg/mL) and institution. METHODS A computer- generated randomisation list was used, which was preordered for each stratum. The randomisation sequence was Study design and ethical issues http://gut.bmj.com/ This study was designed as a multicentre, open- label, randomised concealed for all investigators. Patients and investigators were controlled trial. This study was conducted in accordance with not blinded to the allocated treatment group. the Declaration of Helsinki and the guidelines of the Consol- idated Standards of Reporting Trials (CONSORT). This study Study outcomes was registered with the University Hospital Medical Information The primary endpoint in this study was the H.
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