Fourteen-day vonoprazan and low- or high-dose amoxicillin dual therapy for eradicating Helicobacter pylori infection: A prospective, open-labeled, randomized non-inferiority clinical study
oleh: Yi Hu, Yi Hu, Xin Xu, Xin Xu, Xiao-Shun Liu, Xiao-Shun Liu, Cong He, Cong He, Yao-Bin Ouyang, Yao-Bin Ouyang, Nian-Shuang Li, Nian-Shuang Li, Chuan Xie, Chuan Xie, Chao Peng, Chao Peng, Zhen-Hua Zhu, Zhen-Hua Zhu, Yong Xie, Yong Xie, Xu Shu, Xu Shu, Yin Zhu, Yin Zhu, David Y. Graham, Nong-Hua Lu, Nong-Hua Lu
| Format: | Article |
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| Diterbitkan: | Frontiers Media S.A. 2023-01-01 |
Deskripsi
Background and aimWe previously reported that vonoprazan-amoxicillin (VA) dual therapy for 7 or 10 days is not satisfactorily efficacious for Helicobacter pylori (H. pylori) eradication. We aimed to explore the efficacy of VA dual therapy for 14 days as a first-line treatment for H. pylori infection.MethodsThis was a single center, prospective, open-labeled, randomized non-inferiority clinical study conducted in China. Treatment naïve H. pylori infected patients were randomized into two groups: 20 mg vonoprazan (VPZ) b.i.d. in combination with low-dose (1000 mg b.i.d.) or high-dose (1000 mg t.i.d) amoxicillin for 14 days. 13C-urea breath tests were used to access the cure rate at least 4 weeks after treatment.ResultsA total of 154 patients were assessed and 110 subjects were randomized. The eradication rate of VPZ with b.i.d. amoxicillin or t.i.d. amoxicillin for 14 days was 89.1% and 87.3% by intention-to-treat analysis, respectively, and 94.1% and 95.9% by per-protocol analysis, respectively. The eradication rate and incidence of adverse events were not different between the two groups.ConclusionVPZ with b.i.d. or t.i.d. amoxicillin for 14 days provides satisfactory efficacy as a first-line treatment for H. pylori infection in China.