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Randomized Controlled Trial
. 2024 Jul 21;30(27):3304-3313.
doi: 10.3748/wjg.v30.i27.3304.

Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population: A prospective, multicenter, randomized, two-stage study

Xue-Ping Huang  1   2 , Yi-Juan Liu  3 , Shao-Wei Lin  4 , Yan-Feng Shao  5 , Feng Qiu  6 , Qing-Wu Qiu  7 , Zhang-Kun Xu  8 , Jin-Xian Chen  9 , Liang-Huo Chen  10 , Zhen-Qun Lin  11 , Wen-Hua Dai  12 , Ming-Qing Zhang  13 , Qi Jiang  14 , Zhong-Qin Xiao  15 , Xian-Xing Cheng  16 , Xiang-Fei Zhang  17 , Wen-Bin You  18 , Wei Chen  18 , Long-Qin Li  19 , Wei-Xing Lin  20 , Yong-Fu Wang  21 , Fu-Jin Lai  22 , Long-Qun Chen  23 , Zhong-Hua Huang  24 , Wen-Qi Zheng  25 , Jin-Qi Wei  26 , Zhi-Hui Lin  1   27
Affiliations
Randomized Controlled Trial

Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population: A prospective, multicenter, randomized, two-stage study

Xue-Ping Huang et al. World J Gastroenterol. .

Abstract

Background: The efficacy of Vonoprazan-amoxicillin dual therapy (VAT) in the treatment of Helicobacter pylori (H. pylori) is controversial.

Aim: To evaluate the efficacy of VAT in the Chinese population.

Methods: This prospective, multicenter, randomized, open-label, and two-stage study was conducted at 23 centers in Fujian, China (May 2021-April 2022). H. pylori-infected patients were randomized to bismuth quadruple therapy (BQT), BQT-Vonoprazan (BQT-V), seven-day VAT (VAT-7), ten-day VAT (VAT-10), and fourteen-day VAT (VAT-14) groups. The primary endpoint was the H. pylori eradication rate. The secondary endpoint was the frequency of adverse events. This study was registered with the Chinese Clinical Trial Registry, ChiCTR2100045778.

Results: In the first stage, VAT-7 and BQT-V groups were selected for early termination because less than 23 among 28 cases were eradicated. In the second stage, the eradication rates for BQT, VAT-10, and VA-14 were 80.2% [95% confidence interval (95%CI): 71.4%-86.8%], 93.2% (86.6%-96.7%), 92.2% (85.3%-96.0%) in the intention-to-treat (ITT) analysis, and 80.9% (95%CI: 71.7%-87.5%), 94.0% (87.5%-97.2%), and 93.9% (87.4%-97.2%) in the per-protocol analysis. The ITT analysis showed a higher eradication rate in the VAT-10 and VAT-14 groups than in the BQT group (P = 0.022 and P = 0.046, respectively). The incidence of adverse events in the VAT-10 and VAT-14 groups was lower than in the BQT group (25.27% and 13.73% vs 37.62%, respectively; P < 0.001).

Conclusion: VAT with a duration of 10 or 14 days achieves a higher eradication rate than the BQT, with a more tolerable safety profile in H. pylori-infected patients in Fujian.

Keywords: Amoxicillin; Bismuth quadruple therapy; Dual therapy; Helicobacter pylori; Vonoprazan.

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Conflict of interest statement

Conflict-of-interest statement: The authors declare that they have no conflict of interest to disclose.

Figures

Figure 1
Figure 1
Flowchart of the clinical trial. VAT: Vonoprazan-amoxicillin dual therapy; BQT: Bismuth quadruple therapy; ITT: Intention-to-treat; PP: Per-protocol.
Figure 2
Figure 2
Intention-to-treat and per-protocol analyses of Helicobacter pylori eradication rates attained by bismuth quadruple therapy, Vonoprazan-amoxicillin dual therapy-10 and Vonoprazan-amoxicillin dual therapy-14. There were statistically significant differences in the eradication rates among the three regimens. VAT: Vonoprazan-amoxicillin dual therapy; BQT: Bismuth quadruple therapy; ITT: Intention-to-treat; PP: Per-protocol; 95%CI: 95% confidence interval.
See this image and copyright information in PMC

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