PMID- 36729890 OWN - NLM STAT- MEDLINE DCOM- 20230331 LR - 20230619 IS - 1572-0241 (Electronic) IS - 0002-9270 (Linking) VI - 118 IP - 4 DP - 2023 Apr 1 TI - Ten-Day Vonoprazan-Amoxicillin Dual Therapy as a First-Line Treatment of Helicobacter pylori Infection Compared With Bismuth-Containing Quadruple Therapy. PG - 627-634 LID - 10.14309/ajg.0000000000002086 [doi] AB - INTRODUCTION: No study has investigated the efficacy and safety of vonoprazan-amoxicillin dual therapy compared with bismuth quadruple therapy (B-quadruple). This study aimed to evaluate the efficacy and safety of 10-day vonoprazan-amoxicillin dual therapy as a first-line treatment of Helicobacter pylori infection compared with B-quadruple and to explore the optimal dosage of amoxicillin in the dual therapy. METHODS: A total of 375 treatment-naive, H. pylori -infected subjects were randomly assigned in a 1:1:1 ratio into 3 regimen groups including VHA-dual (vonoprazan 20 mg twice/day + amoxicillin 750 mg 4 times/day), VA-dual (vonoprazan 20 mg + amoxicillin 1,000 mg twice/day), and B-quadruple (esomeprazole 20 mg + bismuth 200 mg + amoxicillin 1,000 mg + clarithromycin 500 mg twice/day). Eradication rates, adverse events (AEs), and compliance were compared between 3 groups. RESULTS: The eradication rates of B-quadruple, VHA-dual, and VA-dual were 90.9%, 93.4%, and 85.1%, respectively, by per-protocol analysis; 89.4%, 92.7%, and 84.4%, respectively, by modified intention-to-treat analysis; 88.0%, 91.2%, and 82.4%, respectively, by intention-to-treat analysis. The efficacy of the VHA-dual group was not inferior to the B-quadruple group ( P < 0.001), but VA-dual did not reach a noninferiority margin of -10%. The AEs rates of the B-quadruple group were significantly higher than those of the VHA-dual ( P = 0.012) and VA-dual ( P = 0.001) groups. There was no significant difference in medication compliance among 3 treatment groups ( P = 0.995). CONCLUSIONS: The 10-day VHA-dual therapy provided satisfactory eradication rates of >90%, lower AEs rates, and similar adherence compared with B-quadruple therapy as a first-line therapy for H. pylori infection. However, the efficacy of VA-dual therapy was not acceptable. CI - Copyright (c) 2022 by The American College of Gastroenterology. FAU - Qian, Hai-Sheng AU - Qian HS AUID- ORCID: 0000-0002-5329-0182 AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Li, Wen-Jie AU - Li WJ AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Dang, Yi-Ni AU - Dang YN AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Li, Lu-Rong AU - Li LR AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Xu, Xiao-Bing AU - Xu XB AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Yuan, Lin AU - Yuan L AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Zhang, Wei-Feng AU - Zhang WF AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Yang, Zhen AU - Yang Z AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Gao, Xin AU - Gao X AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Zhang, Min AU - Zhang M AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Li, Xuan AU - Li X AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. FAU - Zhang, Guo-Xin AU - Zhang GX AD - Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. AD - Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20221202 PL - United States TA - Am J Gastroenterol JT - The American journal of gastroenterology JID - 0421030 RN - 804826J2HU (Amoxicillin) RN - U015TT5I8H (Bismuth) RN - 0 (1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine) RN - 0 (Anti-Bacterial Agents) RN - H1250JIK0A (Clarithromycin) RN - 0 (Proton Pump Inhibitors) SB - IM CIN - Ann Intern Med. 2023 May;176(5):JC54. PMID: 37126819 MH - Humans MH - *Helicobacter Infections/drug therapy MH - Amoxicillin/therapeutic use MH - Bismuth/therapeutic use MH - *Helicobacter pylori MH - Anti-Bacterial Agents MH - Drug Therapy, Combination MH - Clarithromycin/therapeutic use MH - Treatment Outcome MH - Proton Pump Inhibitors/adverse effects EDAT- 2023/02/03 06:00 MHDA- 2023/03/31 06:41 CRDT- 2023/02/02 12:52 PHST- 2022/06/23 00:00 [received] PHST- 2022/11/02 00:00 [accepted] PHST- 2023/03/31 06:41 [medline] PHST- 2023/02/03 06:00 [pubmed] PHST- 2023/02/02 12:52 [entrez] AID - 00000434-202304000-00017 [pii] AID - 10.14309/ajg.0000000000002086 [doi] PST - ppublish SO - Am J Gastroenterol. 2023 Apr 1;118(4):627-634. doi: 10.14309/ajg.0000000000002086. Epub 2022 Dec 2.