Helicobacter · 2025
Efficacy of Three Amoxicillin Doses in Vonoprazan Dual Therapy for Helicobacter pylori Eradication: A Randomized Noninferiority Trial.
Клиническое исследование IV фазыEquivalence TrialСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Peng Ruolin, Cai Pengpeng, Zhang Zhimei, Lv Shengxiang, Chen Guangxia, Xu Yuling, He Bin, Sun Min, Dai Xiaorong, Yan Kunfeng, Shen Lu, Wang Jianrong, Li Wei, Yin Rui, Ge Jianxin, Hu Duanmin, Hu Kewei, Xu Xiaodan, Li Hui, Pan Chengyu, Duan Zhaotao, Gao Xuefeng, Zhang Zhenyu, Liu Wanli
Аннотация
BACKGROUND: Limited research has explored the efficacy of reduced amoxicillin dosages in vonoprazan-amoxicillin (VA) dual therapy for Helicobacter pylori eradication in China, and this study aimed to assess the noninferiority of these lower dosages compared to the standard high dose (3 g/d).
METHODS: This was a noninferiority study with a -10% margin. H. pylori-positive patients from 13 centers in Jiangsu Province, China, were randomly assigned in a 1:1:1 ratio to receive a 14-day treatment, consisting of vonoprazan (20 mg BID) and high-dose amoxicillin (1 g TID, HVA), medium-dose amoxicillin (1 g BID, MVA), or low-dose amoxicillin (0.5 g TID, LVA). The eradication rates, adverse events (AEs), and medication adherence were compared.
RESULTS: From January 13, 2023 to July 6, 2024, a total of 900 patients were enrolled. According to the intention-to-treat (ITT) and per-protocol (PP) analyses, the eradication rates for HVA, MVA, and LVA groups were 93.2% and 93.2%, 91.6% and 91.5%, and 87.0% and 86.8%, respectively. The efficacy of MVA was noninferior to HVA in ITT analysis (difference: -1.6%, 97.5% CI: -7.0% to 3.8%, p < 0.001) and PP analysis (difference: -1.7%, 97.5% CI: -7.1% to 3.7%, p < 0.001); LVA's effectiveness was less than HVA in ITT analysis (difference: -6.2%, 97.5% CI: -12.2% to -0.2%, p = 0.076) and PP analysis (difference:-6.4%, 97.5% CI: -12.4% to -0.3%, p = 0.089). The incidence of AEs and medication compliance among the three groups was similar.
CONCLUSIONS: A 14-day VA regimen requires ≥ 2 g/d amoxicillin to maintain noninferior eradication efficacy versus 3 g/d, supporting dose reduction without compromising effectiveness.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05649540.
METHODS: This was a noninferiority study with a -10% margin. H. pylori-positive patients from 13 centers in Jiangsu Province, China, were randomly assigned in a 1:1:1 ratio to receive a 14-day treatment, consisting of vonoprazan (20 mg BID) and high-dose amoxicillin (1 g TID, HVA), medium-dose amoxicillin (1 g BID, MVA), or low-dose amoxicillin (0.5 g TID, LVA). The eradication rates, adverse events (AEs), and medication adherence were compared.
RESULTS: From January 13, 2023 to July 6, 2024, a total of 900 patients were enrolled. According to the intention-to-treat (ITT) and per-protocol (PP) analyses, the eradication rates for HVA, MVA, and LVA groups were 93.2% and 93.2%, 91.6% and 91.5%, and 87.0% and 86.8%, respectively. The efficacy of MVA was noninferior to HVA in ITT analysis (difference: -1.6%, 97.5% CI: -7.0% to 3.8%, p < 0.001) and PP analysis (difference: -1.7%, 97.5% CI: -7.1% to 3.7%, p < 0.001); LVA's effectiveness was less than HVA in ITT analysis (difference: -6.2%, 97.5% CI: -12.2% to -0.2%, p = 0.076) and PP analysis (difference:-6.4%, 97.5% CI: -12.4% to -0.3%, p = 0.089). The incidence of AEs and medication compliance among the three groups was similar.
CONCLUSIONS: A 14-day VA regimen requires ≥ 2 g/d amoxicillin to maintain noninferior eradication efficacy versus 3 g/d, supporting dose reduction without compromising effectiveness.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05649540.