Jae Yong Park, Il Ju Choi, Gwang Ha Kim, Su Jin Hong, Sung Kwan Shin, Seong Woo Jeon, Jae Gyu Kim
{"title":"以钾竞争性酸阻滞剂为基础的替戈拉赞三联疗法与伏诺哌赞根除幽门螺杆菌的疗效比较：一项随机、双盲、主动对照的初步研究。","authors":"Jae Yong Park, Il Ju Choi, Gwang Ha Kim, Su Jin Hong, Sung Kwan Shin, Seong Woo Jeon, Jae Gyu Kim","doi":"10.5009/gnl250067","DOIUrl":null,"url":null,"abstract":"<p><strong>Background/aims: </strong>Triple therapy with vonoprazan, a potassium-competitive acid blocker, has shown an acceptable eradication rate. The aim of this study was to evaluate the efficacy and safety of tegoprazan-based triple therapy compared with those of vonoprazan-based triple therapy for <i>Helicobacter pylori</i> eradication.</p><p><strong>Methods: </strong>This randomized, double-blind, active-controlled, multicenter pilot study included treatment-naive adults with <i>H. pylori</i> infection. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC 1), tegoprazan 100 mg (TAC 2), or vonoprazan 20 mg (VAC) with amoxicillin 1,000 mg plus clarithromycin 500 mg twice daily for 10 days. The primary outcome was the eradication rate.</p><p><strong>Results: </strong>Of the 102 enrolled participants, 97 completed the study. The eradication rates in the full analysis set were 60.61% (95% confidence interval [CI], 43.93% to 77.28%), 78.79% (95% CI, 64.84% to 92.74%), and 84.85% (95% CI, 72.62% to 97.08%) in TAC 1, TAC 2, and VAC, respectively. The eradication rates in the per-protocol set were 66.67% (95% CI, 49.80% to 83.54%), 86.67% (95% CI, 74.50% to 98.83%), and 87.50% (95% CI, 76.04% to 98.96%) in TAC 1, TAC 2, and VAC, respectively. In the full analysis set, the eradication rate differences were -6.06% (95% CI, -24.61% to 12.49%) between TAC 2 and VAC and -24.24% (95% CI, -44.92% to -3.56%) between TAC 1 and VAC. In the per-protocol set, the eradication rate differences were -0.83% (95% CI, -19.97% to 17.37%) between TAC 2 and VAC and -20.83% (95% CI, -41.23% to -0.44%) between TAC 1 and VAC. All therapies were well tolerated with no notable safety differences.</p><p><strong>Conclusions: </strong>After 10 days, tegoprazan 100 mg showed eradication rates comparable to those of vonoprazan 20 mg, while 50 mg may be insufficient. These findings support future research to optimize tegoprazan dosing in clinical practice (ClinicalTrials.gov; NCT04128917).</p>","PeriodicalId":12885,"journal":{"name":"Gut and Liver","volume":" ","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative Efficacy of Potassium-Competitive Acid Blocker-Based Triple Therapy with Tegoprazan versus Vonoprazan for <i>Helicobacter pylori</i> Eradication: A Randomized, Double-Blind, Active-Controlled Pilot Study.\",\"authors\":\"Jae Yong Park, Il Ju Choi, Gwang Ha Kim, Su Jin Hong, Sung Kwan Shin, Seong Woo Jeon, Jae Gyu Kim\",\"doi\":\"10.5009/gnl250067\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background/aims: </strong>Triple therapy with vonoprazan, a potassium-competitive acid blocker, has shown an acceptable eradication rate. The aim of this study was to evaluate the efficacy and safety of tegoprazan-based triple therapy compared with those of vonoprazan-based triple therapy for <i>Helicobacter pylori</i> eradication.</p><p><strong>Methods: </strong>This randomized, double-blind, active-controlled, multicenter pilot study included treatment-naive adults with <i>H. pylori</i> infection. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC 1), tegoprazan 100 mg (TAC 2), or vonoprazan 20 mg (VAC) with amoxicillin 1,000 mg plus clarithromycin 500 mg twice daily for 10 days. The primary outcome was the eradication rate.</p><p><strong>Results: </strong>Of the 102 enrolled participants, 97 completed the study. The eradication rates in the full analysis set were 60.61% (95% confidence interval [CI], 43.93% to 77.28%), 78.79% (95% CI, 64.84% to 92.74%), and 84.85% (95% CI, 72.62% to 97.08%) in TAC 1, TAC 2, and VAC, respectively. The eradication rates in the per-protocol set were 66.67% (95% CI, 49.80% to 83.54%), 86.67% (95% CI, 74.50% to 98.83%), and 87.50% (95% CI, 76.04% to 98.96%) in TAC 1, TAC 2, and VAC, respectively. In the full analysis set, the eradication rate differences were -6.06% (95% CI, -24.61% to 12.49%) between TAC 2 and VAC and -24.24% (95% CI, -44.92% to -3.56%) between TAC 1 and VAC. In the per-protocol set, the eradication rate differences were -0.83% (95% CI, -19.97% to 17.37%) between TAC 2 and VAC and -20.83% (95% CI, -41.23% to -0.44%) between TAC 1 and VAC. All therapies were well tolerated with no notable safety differences.</p><p><strong>Conclusions: </strong>After 10 days, tegoprazan 100 mg showed eradication rates comparable to those of vonoprazan 20 mg, while 50 mg may be insufficient. These findings support future research to optimize tegoprazan dosing in clinical practice (ClinicalTrials.gov; NCT04128917).</p>\",\"PeriodicalId\":12885,\"journal\":{\"name\":\"Gut and Liver\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-06-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Gut and Liver\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.5009/gnl250067\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gut and Liver","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.5009/gnl250067","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Comparative Efficacy of Potassium-Competitive Acid Blocker-Based Triple Therapy with Tegoprazan versus Vonoprazan for Helicobacter pylori Eradication: A Randomized, Double-Blind, Active-Controlled Pilot Study.
Background/aims: Triple therapy with vonoprazan, a potassium-competitive acid blocker, has shown an acceptable eradication rate. The aim of this study was to evaluate the efficacy and safety of tegoprazan-based triple therapy compared with those of vonoprazan-based triple therapy for Helicobacter pylori eradication.
Methods: This randomized, double-blind, active-controlled, multicenter pilot study included treatment-naive adults with H. pylori infection. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC 1), tegoprazan 100 mg (TAC 2), or vonoprazan 20 mg (VAC) with amoxicillin 1,000 mg plus clarithromycin 500 mg twice daily for 10 days. The primary outcome was the eradication rate.
Results: Of the 102 enrolled participants, 97 completed the study. The eradication rates in the full analysis set were 60.61% (95% confidence interval [CI], 43.93% to 77.28%), 78.79% (95% CI, 64.84% to 92.74%), and 84.85% (95% CI, 72.62% to 97.08%) in TAC 1, TAC 2, and VAC, respectively. The eradication rates in the per-protocol set were 66.67% (95% CI, 49.80% to 83.54%), 86.67% (95% CI, 74.50% to 98.83%), and 87.50% (95% CI, 76.04% to 98.96%) in TAC 1, TAC 2, and VAC, respectively. In the full analysis set, the eradication rate differences were -6.06% (95% CI, -24.61% to 12.49%) between TAC 2 and VAC and -24.24% (95% CI, -44.92% to -3.56%) between TAC 1 and VAC. In the per-protocol set, the eradication rate differences were -0.83% (95% CI, -19.97% to 17.37%) between TAC 2 and VAC and -20.83% (95% CI, -41.23% to -0.44%) between TAC 1 and VAC. All therapies were well tolerated with no notable safety differences.
Conclusions: After 10 days, tegoprazan 100 mg showed eradication rates comparable to those of vonoprazan 20 mg, while 50 mg may be insufficient. These findings support future research to optimize tegoprazan dosing in clinical practice (ClinicalTrials.gov; NCT04128917).
期刊介绍：
Gut and Liver is an international journal of gastroenterology, focusing on the gastrointestinal tract, liver, biliary tree, pancreas, motility, and neurogastroenterology. Gut and Liver delivers up-to-date, authoritative papers on both clinical and research-based topics in gastroenterology. The Journal publishes original articles, case reports, brief communications, letters to the editor and invited review articles in the field of gastroenterology. The Journal is operated by internationally renowned editorial boards and designed to provide a global opportunity to promote academic developments in the field of gastroenterology and hepatology.
Gut and Liver is jointly owned and operated by 8 affiliated societies in the field of gastroenterology, namely: the Korean Society of Gastroenterology, the Korean Society of Gastrointestinal Endoscopy, the Korean Society of Neurogastroenterology and Motility, the Korean College of Helicobacter and Upper Gastrointestinal Research, the Korean Association for the Study of Intestinal Diseases, the Korean Association for the Study of the Liver, the Korean Pancreatobiliary Association, and the Korean Society of Gastrointestinal Cancer.
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