Vonoprazan and high‐dose amoxicillin dual therapy for <i>Helicobacter pylori</i> first‐line eradication: A single‐arm, interventional study

Sue, Soichiro; Kondo, Masaaki; Satô, Takeshi; Oka, Hiroyuki; Sanga, Katsuyuki; Ogashiwa, Tsuyoshi; Matsubayashi, Mao; Kaneko, Hiroaki; Irie, Kazuhiro; Maeda, Shin

doi:10.1002/jgh3.12852

Cited by 8 publications

(16 citation statements)

References 29 publications

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“…Of the 18 included studies, there were 14 RCTs, 9,14,[21][22][23][24][25][26][27][28][29][30]32,33 3 observational studies, 12,13,20 and 1 single-arm study. 31 In these studies overall, I 2 = 91.3%, p < 0.0001; Figure S2) with 1000 mg tid and 750 mg qid, respectively.…”

Section: Study Selection and Characteristicsmentioning

confidence: 75%

“…Figure 1 presents detailed reasons for exclusion. Of the 18 studies included, 11 studies 9,13,20,21,[23][24][25][26][29][30][31] analyzed the eradication effects of VLA dual therapies, and VHA dual therapies were also reported by 11studies. 9,12,14,[22][23][24][25]27,28,32,33 As shown in Table 1, the characteristics of the 18 included studies are summarized.…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…After removing 459 duplicates, 491 studies were excluded after assessing the titles or abstracts. Thirty full-text articles were deemed eligible, of which 18 studies 9,[12][13][14][20][21][22][23][24][25][26][27][28][29][30][31][32][33] were eventually included in the meta-analysis.…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

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Low‐dose or high‐dose amoxicillin in vonoprazan‐based dual therapy for Helicobacter pylori eradication? A systematic review and meta‐analysis

Ju,

Kong,

et al. 2024

Helicobacter

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BackgroundThe amoxicillin dose used in dual therapy to eradicate Helicobacter pylori varies across studies and the optimal amoxicillin dose for vonoprazan‐based dual therapies remains unclear. We aimed to investigate the efficacy and safety of low‐ and high‐dose amoxicillin in vonoprazan–amoxicillin dual therapy.Materials and MethodsA comprehensive systematic review was conducted by searching databases from inception to October 2023. All trials that evaluated the effectiveness and safety of vonoprazan–amoxicillin dual therapy for eradicating H. pylori were included. Pooled eradication rate, incidence of adverse events, relative risks, and 95% confidence intervals are presented.ResultsEighteen studies with 12 low‐dose amoxicillin (VLA) and 13 high‐dose amoxicillin (VHA) arms were included. The pooled eradication rates were 82.4% and 86.8% for VLA therapy, and 86.0% and 90.9% for VHA therapy by the intention‐to‐treat and per‐protocol analyses, respectively. In the subgroup analysis stratified by duration, the eradication rates achieved in 7 days, 10 days, and 14 days treatments with VLA and VHA dual therapies were 80.8%, 84.2%, 83.1%, and 67.3%, 88.8%, 87.5%, respectively. In the four randomized controlled trials that directly compared VLA and VHA dual therapies, the efficacy was not statistically different in the intention‐to‐treat (76.9% vs 81.4%, p = 0.337) and per‐protocol (81.6% vs 84.0%, p = 0.166) analyses. Additionally, the incidence of adverse events (p = 0.965) and compliance (p = 0.994) were similar in both groups.ConclusionVLA therapy demonstrated comparable efficacy and safety to VHA therapy, along with regional differences. An appropriately extended treatment duration may be critical for therapeutic optimization of vonoprazan–amoxicillin treatment.

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Section: Study Selection and Characteristicsmentioning

confidence: 75%

Section: Study Selection and Characteristicsmentioning

confidence: 99%

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Low‐dose or high‐dose amoxicillin in vonoprazan‐based dual therapy for Helicobacter pylori eradication? A systematic review and meta‐analysis

Ju,

Kong,

et al. 2024

Helicobacter

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“…A higher eradication rate (94.4% in PP analysis) of 7‐days VA was reported by a retrospectively study, 19 amoxicillin was used 500 mg three times daily. The efficacy of vonoprazan with high‐dose (500 mg four times daily, 2000 mg/day) amoxicillin dual therapy for 7 days was also evaluated in Japan and the eradication rate was reported as 94.4% 20 . However, the sample size of this study was limited.…”

Section: Discussionmentioning

confidence: 95%

“…The efficacy of vonoprazan with high-dose (500 mg four times daily, 2000 mg/day) amoxicillin dual therapy for 7 days was also evaluated in Japan and the eradication rate was reported as 94.4%. 20 However, the sample size of this study was limited. We reported that vonoprazan with 2 g daily or 3 g daily amoxicillin for 7 days and showed unacceptable low efficacy in China, 21 which was further confirmed by a multicenter study.…”

Section: Discussionmentioning

confidence: 96%

Vonoprazan and amoxicillin dual therapy for 14 days as the first‐line treatment of Helicobacter pylori infection: A non‐inferiority, randomized clinical trial

Hu,

Huang,

Zhou

et al. 2024

Helicobacter

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BackgroundWe previously optimized the duration and dose of vonoprazan and amoxicillin dual therapy in China. The efficacy of vonoprazan with b.i.d. amoxicillin in comparison with vonoprazan‐containing quadruple therapy as the first‐line treatment of Helicobacter pylori infection has not been adequately evaluated.MethodsIn a non‐inferiority, randomized clinical trial, H. pylori infected and treatment‐naïve patients were randomly assigned to receive 14 days of either vonoprazan dual (vonoprazan 20 mg and amoxicillin 1 g twice daily) or quadruple therapy (vonoprazan 20 mg + amoxicillin 1 g + furazolidone 100 mg + bismuth potassium citrate 600 mg twice daily). H. pylori status was confirmed using 13C‐urea breath tests or fecal antigen test. The primary outcome was the H. pylori eradication rate following vonoprazan dual and quadruple therapy at 4–12 weeks. We also compared drug compliance to either regimen and documented their side effect.ResultsA total of 190 subjects were randomized. The eradication rate of vonoprazan dual and quadruple therapy were 87.4% and 92.6% (p = 0.23) by intention‐to‐treat analysis, respectively, and 96.5% and 97.7% (p = 0.63) by per‐protocol analysis, respectively. The efficacy of vonoprazan dual therapy was non‐inferior to vonoprazan‐containing quadruple therapy in per‐protocol analysis (p < 0.001; difference: −1.2%; 90% confidence interval: −5.4% to 3.0%).ConclusionVonoprazan with b.i.d. amoxicillin for 14 days provided similar satisfactory efficacy with vonoprazan‐containing quadruple therapy as a first‐line H. pylori treatment in China.

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Comparison of metronidazole versus clarithromycin in first‐line vonoprazan‐based triple therapy for Helicobacter pylori: A multicenter randomized trial in Japan

Sue,

Oka,

Kunishi

et al. 2024

JGH Open

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Background and AimTo date, no randomized trials have compared the efficacy of 7‐day vonoprazan, amoxicillin, and metronidazole triple therapy (VAM) versus 7‐day vonoprazan, amoxicillin, and clarithromycin triple therapy (VAC) as a first‐line treatment for Helicobacter pylori eradication. This study was performed to compare the efficacy of VAM and VAC as first‐line treatments.MethodsThis prospective multicenter randomized trial was performed in Japan and involved 124 H. pylori‐positive patients without a history of eradication. Patients without antibiotic resistance testing of H. pylori were eligible. The patients were randomized to receive either VAC (vonoprazan 20 mg + amoxicillin 750 mg + clarithromycin 200 or 400 mg twice a day) or VAM (vonoprazan 20 mg + amoxicillin 750 mg + metronidazole 250 mg twice a day) for 7 days, with stratification by age and sex. Eradication success was evaluated using the 13C‐urea breath test. We evaluated safety using patient questionnaires (UMIN000025773).ResultsThe intention‐to‐treat and per‐protocol eradication rates of VAM were 91.3% (95% confidence interval [CI], 82.0–96.7%) and 92.6% (95% CI, 83.7–97.6%), respectively, and those of VAC were 89.1% (95% CI, 77.8–95.9%) and 96.1% (95% CI, 86.5–99.5%), respectively. No significant difference was observed between VAM and VAC in either analysis (P = 0.76 and P = 0.70, respectively). Abdominal fullness was more frequent in patients who received VAM than VAC.ConclusionsThese findings suggest that VAM as a first‐line treatment in Japan can be categorized as grade B (intention‐to‐treat cure rate of 90–95%) and have potential as a first‐line national insurance ‐approved regimen.

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Vonoprazan and high‐dose amoxicillin dual therapy for Helicobacter pylori first‐line eradication: A single‐arm, interventional study

Cited by 8 publications

References 29 publications

Low‐dose or high‐dose amoxicillin in vonoprazan‐based dual therapy for Helicobacter pylori eradication? A systematic review and meta‐analysis

Low‐dose or high‐dose amoxicillin in vonoprazan‐based dual therapy for Helicobacter pylori eradication? A systematic review and meta‐analysis

Vonoprazan and amoxicillin dual therapy for 14 days as the first‐line treatment of Helicobacter pylori infection: A non‐inferiority, randomized clinical trial

Comparison of metronidazole versus clarithromycin in first‐line vonoprazan‐based triple therapy for Helicobacter pylori: A multicenter randomized trial in Japan

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