PMID- 38526917 OWN - NLM STAT- MEDLINE DCOM- 20240429 LR - 20240429 IS - 1473-5687 (Electronic) IS - 0954-691X (Linking) VI - 36 IP - 6 DP - 2024 Jun 1 TI - Vonoprazan-amoxicillin dual therapy with different amoxicillin dosages for treatment-naive patients of Helicobacter pylori infection in China: a prospective, randomized controlled study. PG - 712-719 LID - 10.1097/MEG.0000000000002760 [doi] AB - BACKGROUND: The vonoprazan (VPZ)-amoxicillin (AMO) dual therapy (VA) demonstrates a satisfactory eradication rate for Helicobacter pylori (H. pylori ). However, the optimal dosage of AMO in this regimen remains uncertain. The objective of this study is to investigate the efficacy of different doses of AMO in the VA regimen for first-line treatment of H. pylori infection. METHODS: A total of 192 treatment-naive H. pylori -infected patients were randomly assigned to one of three groups: low-dose VA (LD-VA: VPZ 20 mg b.i.d + AMO 750 mg t.i.d), moderate-dose VA (MD-VA:VPZ 20 mg b.i.d + AMO 1000 mg t.i.d), and high-dose VA (HD-VA: VPZ 20 mg b.i.d + AMO 1250 mg t.i.d). All groups received 14 days of treatment. The study evaluated and compared the eradication rates, adverse events (AEs), and patient compliance among the three groups. RESULTS: Eradication rates for LD-VA, MD-VA, and HD-VA were 76.6% (49/64), 79.7% (51/64), and 84.4% (54/64), respectively, as determined by intention-to-treat analysis; 90.6% (48/53), 94.3% (50/53), and 98.1% (53/54) according to per-protocol analysis; 89.1% (49/55), 94.4% (51/54), and 96.4% (54/56) with modified intention-to-treat analysis (all P > 0.05). Although not statistically significant, numerically higher eradication rates were observed with the higher dose AMO VA regimen. There were no statistically significant differences in the incidence of AEs and compliance among the three VA regimens. CONCLUSION: Fourteen-day VA regimens with AMO doses exceeding 2 g/day demonstrated satisfactory eradication rates. HD-VA therapy is potentially the most effective regimen. Large-sample clinical trials are required to further validate these findings. CI - Copyright (c) 2024 Wolters Kluwer Health, Inc. All rights reserved. FAU - Liu, Zhu AU - Liu Z AD - Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin Institute of Digestive Disease, Tianjin Key Laboratory of Digestive Diseases, Tianjin. AD - Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan. FAU - Sun, Dongjie AU - Sun D AD - Department of Digestive Diseases, The Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China. FAU - Kou, Luan AU - Kou L AD - Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan. FAU - Jia, Li AU - Jia L AD - Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan. FAU - Hao, Jiaorong AU - Hao J AD - Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan. FAU - Zhou, Jihai AU - Zhou J AD - Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan. FAU - Zheng, Wenwen AU - Zheng W AD - Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan. FAU - Gao, Fengyu AU - Gao F AD - Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan. FAU - Chen, Xin AU - Chen X AD - Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin Institute of Digestive Disease, Tianjin Key Laboratory of Digestive Diseases, Tianjin. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20240319 PL - England TA - Eur J Gastroenterol Hepatol JT - European journal of gastroenterology & hepatology JID - 9000874 RN - 0 (Sulfonamides) RN - 0 (1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine) RN - 804826J2HU (Amoxicillin) RN - 0 (Anti-Bacterial Agents) RN - 0 (Pyrroles) RN - 0 (Proton Pump Inhibitors) SB - IM MH - Humans MH - *Helicobacter Infections/drug therapy MH - *Sulfonamides/administration & dosage MH - *Amoxicillin/administration & dosage MH - Male MH - Female MH - Middle Aged MH - *Helicobacter pylori/drug effects MH - *Drug Therapy, Combination MH - *Anti-Bacterial Agents/administration & dosage/adverse effects MH - Prospective Studies MH - *Pyrroles/administration & dosage/adverse effects MH - Adult MH - China MH - Treatment Outcome MH - *Proton Pump Inhibitors/administration & dosage/adverse effects MH - Aged EDAT- 2024/03/25 18:42 MHDA- 2024/04/29 13:58 CRDT- 2024/03/25 12:53 PHST- 2024/03/25 18:42 [pubmed] PHST- 2024/04/29 13:58 [medline] PHST- 2024/03/25 12:53 [entrez] AID - 00042737-990000000-00330 [pii] AID - 10.1097/MEG.0000000000002760 [doi] PST - ppublish SO - Eur J Gastroenterol Hepatol. 2024 Jun 1;36(6):712-719. doi: 10.1097/MEG.0000000000002760. Epub 2024 Mar 19.