Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial
ObjectivesTo evaluate the efficacy and cost-effectiveness of 10-day vonoprazan-amoxicillin (VA) dual therapy compared to 14-day VA therapy.MethodsA non-inferiority trial was carried out at 10 clinical centers to recruit patients with H. pylori infection. Subjects were assigned at random to either th...
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Frontiers Media S.A.
2025-03-01
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| author | Yunfan Dong Zhaotao Duan Min Liu Yanbing Ding Guangxia Chen Ruifang Wang Xiaodan Xu Lixia Ding Qiang Zhan Chengyu Pan Hui Li Faming Yang Xiaorong Dai Xiangsu Li Xudong Wu Peng Peng Jianrong Wang Kewei Hu Duanmin Hu Qiong Jie Zhenyu Zhang |
| author_facet | Yunfan Dong Zhaotao Duan Min Liu Yanbing Ding Guangxia Chen Ruifang Wang Xiaodan Xu Lixia Ding Qiang Zhan Chengyu Pan Hui Li Faming Yang Xiaorong Dai Xiangsu Li Xudong Wu Peng Peng Jianrong Wang Kewei Hu Duanmin Hu Qiong Jie Zhenyu Zhang |
| author_sort | Yunfan Dong |
| collection | DOAJ |
| description | ObjectivesTo evaluate the efficacy and cost-effectiveness of 10-day vonoprazan-amoxicillin (VA) dual therapy compared to 14-day VA therapy.MethodsA non-inferiority trial was carried out at 10 clinical centers to recruit patients with H. pylori infection. Subjects were assigned at random to either the group for 10-day or 14-day, and where given vonoprazan 20 mg bid and amoxicillin 1 g tid. Comparisons were made in terms of eradication rates, adverse events, cost-effectiveness, and compliance.Results914 participants were enrolled and randomly assigned to either the 10-day or 14-day VA groups. Using the intention-to-treat principle and multiple imputation for missing outcomes, the analysis showed an eradication rate of 88.79% in the 10-day group and 92.37% in the 14-day group (P = 0.064). The eradication rates were 89.14% and 93.35% by per-protocol analysis (P = 0.037). There were no significant differences in adverse events or compliance between the groups (P > 0.05). Logistic regression analysis indicated that smoking and prior failure of eradication were risk factors influencing the eradication rate (P < 0.05). For the economic evaluation, the cost-effectiveness ratio (CER) of the 10-day group was 426.30 yuan, the CER of the 14-day group was 485.27 yuan, and the incremental cost-effectiveness ratio was 1680.23 yuan. In probability sensitivity analysis, the cost-effectiveness acceptability curve showed that when the willingness-to-pay(WTP) threshold was below 1742 yuan, the 10-day group was more cost-effective. When the WTP threshold was above 1742 yuan, the 14-day group was more cost-effective.ConclusionIn this study, the 10-day VA was not found to be inferior to the 14-day VA. Compared with the 14-day group, the 10-day group is more cost-effective, but as the WTP threshold increases to 1742 yuan, the probability of the 14-day group being more cost-effective was greater than that of the 10-day group. Smoking and previous eradication attempts were associated with the eradication failure of VA therapy.Clinical Trial Registrationhttps://clinicaltrials.gov/, identifier NCT05469685. |
| format | Article |
| id | doaj-art-89bc0fd312584a27b2a2e71ebb577616 |
| institution | DOAJ |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj-art-89bc0fd312584a27b2a2e71ebb5776162025-08-20T02:40:43ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-03-011610.3389/fphar.2025.15433521543352Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trialYunfan Dong0Zhaotao Duan1Min Liu2Yanbing Ding3Guangxia Chen4Ruifang Wang5Xiaodan Xu6Lixia Ding7Qiang Zhan8Chengyu Pan9Hui Li10Faming Yang11Xiaorong Dai12Xiangsu Li13Xudong Wu14Peng Peng15Jianrong Wang16Kewei Hu17Duanmin Hu18Qiong Jie19Zhenyu Zhang20Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, ChinaDepartment of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, ChinaThe First People’s Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University, Xuzhou, ChinaDepartment of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, ChinaThe First People’s Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University, Xuzhou, ChinaDepartment of Gastroenterology, Changshu No.1 People’s Hospital, Suzhou, ChinaDepartment of Gastroenterology, Changshu No.1 People’s Hospital, Suzhou, ChinaDepartments of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi, Jiangsu, ChinaDepartments of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi, Jiangsu, ChinaAffiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, ChinaAffiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, ChinaDepartment of Gastroenterology, Taixing People’s Hospital, Taixing, ChinaDepartment of Gastroenterology, Taixing People’s Hospital, Taixing, ChinaYancheng No.1 People’s Hospital, Affiliated Hospital of Medical School, Nanjing University, Yancheng, ChinaYancheng No.1 People’s Hospital, Affiliated Hospital of Medical School, Nanjing University, Yancheng, ChinaDepartment of Gastroenterology, Taizhou Fourth People’s Hospital, Taizhou, ChinaDepartment of Gastroenterology, Taizhou Fourth People’s Hospital, Taizhou, China0Department of Gastroenterology, The Second Affiliated Hospital of Soochow University, Suzhou, China0Department of Gastroenterology, The Second Affiliated Hospital of Soochow University, Suzhou, China1Department of Pharmacy, Nanjing First Hospital, Nanjing Medical University, Nanjing, ChinaDepartment of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, ChinaObjectivesTo evaluate the efficacy and cost-effectiveness of 10-day vonoprazan-amoxicillin (VA) dual therapy compared to 14-day VA therapy.MethodsA non-inferiority trial was carried out at 10 clinical centers to recruit patients with H. pylori infection. Subjects were assigned at random to either the group for 10-day or 14-day, and where given vonoprazan 20 mg bid and amoxicillin 1 g tid. Comparisons were made in terms of eradication rates, adverse events, cost-effectiveness, and compliance.Results914 participants were enrolled and randomly assigned to either the 10-day or 14-day VA groups. Using the intention-to-treat principle and multiple imputation for missing outcomes, the analysis showed an eradication rate of 88.79% in the 10-day group and 92.37% in the 14-day group (P = 0.064). The eradication rates were 89.14% and 93.35% by per-protocol analysis (P = 0.037). There were no significant differences in adverse events or compliance between the groups (P > 0.05). Logistic regression analysis indicated that smoking and prior failure of eradication were risk factors influencing the eradication rate (P < 0.05). For the economic evaluation, the cost-effectiveness ratio (CER) of the 10-day group was 426.30 yuan, the CER of the 14-day group was 485.27 yuan, and the incremental cost-effectiveness ratio was 1680.23 yuan. In probability sensitivity analysis, the cost-effectiveness acceptability curve showed that when the willingness-to-pay(WTP) threshold was below 1742 yuan, the 10-day group was more cost-effective. When the WTP threshold was above 1742 yuan, the 14-day group was more cost-effective.ConclusionIn this study, the 10-day VA was not found to be inferior to the 14-day VA. Compared with the 14-day group, the 10-day group is more cost-effective, but as the WTP threshold increases to 1742 yuan, the probability of the 14-day group being more cost-effective was greater than that of the 10-day group. Smoking and previous eradication attempts were associated with the eradication failure of VA therapy.Clinical Trial Registrationhttps://clinicaltrials.gov/, identifier NCT05469685.https://www.frontiersin.org/articles/10.3389/fphar.2025.1543352/fullHelicobacter pylorivonoprazanamoxicillindual therapyeradicationcost-effectiveness |
| spellingShingle | Yunfan Dong Zhaotao Duan Min Liu Yanbing Ding Guangxia Chen Ruifang Wang Xiaodan Xu Lixia Ding Qiang Zhan Chengyu Pan Hui Li Faming Yang Xiaorong Dai Xiangsu Li Xudong Wu Peng Peng Jianrong Wang Kewei Hu Duanmin Hu Qiong Jie Zhenyu Zhang Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial Frontiers in Pharmacology Helicobacter pylori vonoprazan amoxicillin dual therapy eradication cost-effectiveness |
| title | Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial |
| title_full | Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial |
| title_fullStr | Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial |
| title_full_unstemmed | Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial |
| title_short | Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial |
| title_sort | efficacy and cost effectiveness analysis of 10 day versus 14 day eradication of helicobacter pylori infection with vonoprazan amoxicillin a prospective multicenter randomized controlled trial |
| topic | Helicobacter pylori vonoprazan amoxicillin dual therapy eradication cost-effectiveness |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1543352/full |
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