Details

Autor(en) / Beteiligte

• Suzuki, Sho
• Gotoda, Takuji
• Kusano, Chika
• Ikehara, Hisatomo
• Ichijima, Ryoji
• Ohyauchi, Motoki
• Ito, Hirotaka
• Kawamura, Masashi
• Ogata, Yohei
• Ohtaka, Masahiko
• Nakahara, Moriyasu
• Kawabe, Koichi

Titel

Seven-day vonoprazan and low-dose amoxicillin dual therapy as first-line Helicobacter pylori treatment: a multicentre randomised trial in Japan

Ist Teil von

• Gut, 2020-06, Vol.69 (6), p.1019

Ort / Verlag

England

Erscheinungsjahr

2020

Link zum Volltext

Beschreibungen/Notizen

• To date, no randomised trials have compared the efficacy of vonoprazan and amoxicillin dual therapy with other standard regimens for treatment. This study aimed to investigate the efficacy of the 7-day vonoprazan and low-dose amoxicillin dual therapy as a first-line treatment, and compared this with vonoprazan-based triple therapy. This prospective, randomised clinical trial was performed at seven Japanese institutions. Patients with -positive culture test and naive to treatment were randomly assigned in a 1:1 ratio to either VA-dual therapy (vonoprazan 20 mg+amoxicillin 750 mg twice/day) or VAC-triple therapy (vonoprazan 20 mg+amoxicillin 750 mg+clarithromycin 200 mg twice/day) for 7 days, with stratification by age, sex, antimicrobial resistance and institution. Eradication success was evaluated by C-urea breath test at least 4 weeks after treatment. Between October 2018 and June 2019, 629 subjects were screened and 335 were randomised. 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. The 7-day vonoprazan and low-dose amoxicillin dual therapy provided acceptable eradication rates and a similar effect to vonoprazan-based triple therapy in regions with high clarithromycin resistance. UMIN000034140.