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Efficacy and Safety of Vonoprazan-Based Quadruple Therapy for the Eradication of Helicobacter pylori in Patients with Peptic Ulcers: A Pooled Analysis of Two Randomized, Double-Blind, Double-Dummy, Phase 3 Trials
Helicobacter pylori eradication is crucial in the treatment of peptic ulcers caused by H. pylori infection, a disease highly prevalent in Asia. We present a pooled analysis of two randomized, double-blind, double-dummy, phase 3 studies evaluating the efficacy and safety of vonoprazan-based bismuth-c...
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| Published in: | Biological & pharmaceutical bulletin 2024/08/01, Vol.47(8), pp.1405-1414 |
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| container_title | Biological & pharmaceutical bulletin |
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| creator | Hou, Xiaohua Wang, Jiangbin Du, Qin Tian, Dean Hu, Naizhong Liu, Deliang Zhou, Fang Xie, Li Gu, Liqun Kudou, Kentarou Zhang, Shutian |
| description | Helicobacter pylori eradication is crucial in the treatment of peptic ulcers caused by H. pylori infection, a disease highly prevalent in Asia. We present a pooled analysis of two randomized, double-blind, double-dummy, phase 3 studies evaluating the efficacy and safety of vonoprazan-based bismuth-containing quadruple therapy for H. pylori eradication. Patients aged ≥18 years with endoscopically confirmed duodenal or gastric ulcers were randomized 1 : 1 to receive vonoprazan 20 mg or lansoprazole 30 mg once daily for up to 6 (duodenal ulcers) or 8 weeks (gastric ulcers). H. pylori–positive patients received vonoprazan- or lansoprazole-based bismuth-containing quadruple therapy for the first 2 weeks. H. pylori eradication was determined using the carbon-13 urea breath test at a follow-up visit 4 weeks post-treatment. The H. pylori eradication rate was 90.6% with vonoprazan vs. 85.2% with lansoprazole (difference: 5.4%; 95% confidence interval (CI): −0.1, 10.8). H. pylori eradication rates were 7.1% (95% CI: 1.4, 12.8) and 12.6% (95% CI: 3.9, 22.0) higher in patients aged |
| doi_str_mv | 10.1248/bpb.b24-00011 |
| format | article |
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We present a pooled analysis of two randomized, double-blind, double-dummy, phase 3 studies evaluating the efficacy and safety of vonoprazan-based bismuth-containing quadruple therapy for H. pylori eradication. Patients aged ≥18 years with endoscopically confirmed duodenal or gastric ulcers were randomized 1 : 1 to receive vonoprazan 20 mg or lansoprazole 30 mg once daily for up to 6 (duodenal ulcers) or 8 weeks (gastric ulcers). H. pylori–positive patients received vonoprazan- or lansoprazole-based bismuth-containing quadruple therapy for the first 2 weeks. H. pylori eradication was determined using the carbon-13 urea breath test at a follow-up visit 4 weeks post-treatment. The H. pylori eradication rate was 90.6% with vonoprazan vs. 85.2% with lansoprazole (difference: 5.4%; 95% confidence interval (CI): −0.1, 10.8). H. pylori eradication rates were 7.1% (95% CI: 1.4, 12.8) and 12.6% (95% CI: 3.9, 22.0) higher in patients aged <65 years and current smokers, respectively, with vonoprazan vs. lansoprazole. In the Chinese subpopulation, the H. pylori eradication rate was 92.0% with vonoprazan vs. 86.0% with lansoprazole (difference: 6.1%; 95% CI: 0.5, 11.7). Treatment-emergent adverse events occurred in 72.7 vs. 62.6% of H. pylori–positive patients at baseline in the vonoprazan vs. lansoprazole arm. H. pylori eradication with vonoprazan-based quadruple therapy was noninferior to lansoprazole-based quadruple therapy and exceeded 90%, a clinically relevant threshold for determining the efficacy of H. pylori eradication regimens (ClinicalTrials.gov identifier: NCT03050359; NCT03050307).</description><identifier>ISSN: 0918-6158</identifier><identifier>ISSN: 1347-5215</identifier><identifier>EISSN: 1347-5215</identifier><identifier>DOI: 10.1248/bpb.b24-00011</identifier><identifier>PMID: 39085080</identifier><language>eng</language><publisher>Japan: The Pharmaceutical Society of Japan</publisher><subject><![CDATA[Adult ; Aged ; Anti-Bacterial Agents - administration & dosage ; Anti-Bacterial Agents - adverse effects ; Anti-Bacterial Agents - therapeutic use ; Anti-Ulcer Agents - administration & dosage ; Anti-Ulcer Agents - adverse effects ; Anti-Ulcer Agents - therapeutic use ; bismuth-containing quadruple therapy ; Breath Tests ; Carbon 13 ; Clinical trials ; Double-Blind Method ; Drug Therapy, Combination ; Eradication ; Female ; Helicobacter Infections - drug therapy ; Helicobacter Infections - microbiology ; Helicobacter pylori ; Helicobacter pylori - drug effects ; Humans ; lansoprazole ; Lansoprazole - administration & dosage ; Lansoprazole - adverse effects ; Lansoprazole - therapeutic use ; Male ; Middle Aged ; peptic ulcer ; Peptic Ulcer - drug therapy ; Peptic Ulcer - microbiology ; Peptic ulcers ; Proton Pump Inhibitors - administration & dosage ; Proton Pump Inhibitors - adverse effects ; Proton Pump Inhibitors - therapeutic use ; Pyrroles - administration & dosage ; Pyrroles - adverse effects ; Pyrroles - therapeutic use ; Sulfonamides - administration & dosage ; Sulfonamides - adverse effects ; Sulfonamides - therapeutic use ; Treatment Outcome ; Ulcers ; vonoprazan]]></subject><ispartof>Biological and Pharmaceutical Bulletin, 2024/08/01, Vol.47(8), pp.1405-1414</ispartof><rights>2024 Author(s) This is an open access article distributed under the terms of Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/). Published by The Pharmaceutical Society of Japan</rights><rights>2024. This work is published under https://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c372t-f3531d64bc050a974f8136a497220ec82ec9b3e9216f1a76d957c062547f454b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39085080$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hou, Xiaohua</creatorcontrib><creatorcontrib>Wang, Jiangbin</creatorcontrib><creatorcontrib>Du, Qin</creatorcontrib><creatorcontrib>Tian, Dean</creatorcontrib><creatorcontrib>Hu, Naizhong</creatorcontrib><creatorcontrib>Liu, Deliang</creatorcontrib><creatorcontrib>Zhou, Fang</creatorcontrib><creatorcontrib>Xie, Li</creatorcontrib><creatorcontrib>Gu, Liqun</creatorcontrib><creatorcontrib>Kudou, Kentarou</creatorcontrib><creatorcontrib>Zhang, Shutian</creatorcontrib><title>Efficacy and Safety of Vonoprazan-Based Quadruple Therapy for the Eradication of Helicobacter pylori in Patients with Peptic Ulcers: A Pooled Analysis of Two Randomized, Double-Blind, Double-Dummy, Phase 3 Trials</title><title>Biological & pharmaceutical bulletin</title><addtitle>Biol Pharm Bull</addtitle><description>Helicobacter pylori eradication is crucial in the treatment of peptic ulcers caused by H. pylori infection, a disease highly prevalent in Asia. We present a pooled analysis of two randomized, double-blind, double-dummy, phase 3 studies evaluating the efficacy and safety of vonoprazan-based bismuth-containing quadruple therapy for H. pylori eradication. Patients aged ≥18 years with endoscopically confirmed duodenal or gastric ulcers were randomized 1 : 1 to receive vonoprazan 20 mg or lansoprazole 30 mg once daily for up to 6 (duodenal ulcers) or 8 weeks (gastric ulcers). H. pylori–positive patients received vonoprazan- or lansoprazole-based bismuth-containing quadruple therapy for the first 2 weeks. H. pylori eradication was determined using the carbon-13 urea breath test at a follow-up visit 4 weeks post-treatment. The H. pylori eradication rate was 90.6% with vonoprazan vs. 85.2% with lansoprazole (difference: 5.4%; 95% confidence interval (CI): −0.1, 10.8). H. pylori eradication rates were 7.1% (95% CI: 1.4, 12.8) and 12.6% (95% CI: 3.9, 22.0) higher in patients aged <65 years and current smokers, respectively, with vonoprazan vs. lansoprazole. In the Chinese subpopulation, the H. pylori eradication rate was 92.0% with vonoprazan vs. 86.0% with lansoprazole (difference: 6.1%; 95% CI: 0.5, 11.7). Treatment-emergent adverse events occurred in 72.7 vs. 62.6% of H. pylori–positive patients at baseline in the vonoprazan vs. lansoprazole arm. H. pylori eradication with vonoprazan-based quadruple therapy was noninferior to lansoprazole-based quadruple therapy and exceeded 90%, a clinically relevant threshold for determining the efficacy of H. pylori eradication regimens (ClinicalTrials.gov identifier: NCT03050359; NCT03050307).</description><subject>Adult</subject><subject>Aged</subject><subject>Anti-Bacterial Agents - administration & dosage</subject><subject>Anti-Bacterial Agents - adverse effects</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Anti-Ulcer Agents - administration & dosage</subject><subject>Anti-Ulcer Agents - adverse effects</subject><subject>Anti-Ulcer Agents - therapeutic use</subject><subject>bismuth-containing quadruple therapy</subject><subject>Breath Tests</subject><subject>Carbon 13</subject><subject>Clinical trials</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Eradication</subject><subject>Female</subject><subject>Helicobacter Infections - drug therapy</subject><subject>Helicobacter Infections - microbiology</subject><subject>Helicobacter pylori</subject><subject>Helicobacter pylori - drug effects</subject><subject>Humans</subject><subject>lansoprazole</subject><subject>Lansoprazole - administration & dosage</subject><subject>Lansoprazole - adverse effects</subject><subject>Lansoprazole - therapeutic use</subject><subject>Male</subject><subject>Middle Aged</subject><subject>peptic ulcer</subject><subject>Peptic Ulcer - drug therapy</subject><subject>Peptic Ulcer - microbiology</subject><subject>Peptic ulcers</subject><subject>Proton Pump Inhibitors - administration & dosage</subject><subject>Proton Pump Inhibitors - adverse effects</subject><subject>Proton Pump Inhibitors - therapeutic use</subject><subject>Pyrroles - administration & dosage</subject><subject>Pyrroles - adverse effects</subject><subject>Pyrroles - therapeutic use</subject><subject>Sulfonamides - administration & dosage</subject><subject>Sulfonamides - adverse effects</subject><subject>Sulfonamides - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Ulcers</subject><subject>vonoprazan</subject><issn>0918-6158</issn><issn>1347-5215</issn><issn>1347-5215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpdkU1v1DAQhiMEoqVw5IpG4sKhKf7KF7ftdqFIlVhgyzVynDHrlRMHO1GV_k5-EN5uWSQuHll-_MzYb5K8puSCMlG-b4bmomEiJYRQ-iQ5pVwUacZo9jQ5JRUt05xm5UnyIoRdRArC-PPkhFekzEhJTpPfK62NkmoG2bfwXWocZ3AafrjeDV7eyz69lAFb-DrJ1k-DRdhs0cthBu08jFuElZdtVIzG9fub12iNco1UI3oYZuu8AdPDOgLYjwHuzLiFNQ6jUXBrFfrwARawds7GLote2jmYsBdt7hx8i1O5ztxjew5XbmosppfW9P92V1PXzeew3sYhgcPGG2nDy-SZjgVfPdaz5PbjarO8Tm--fPq8XNykihdsTDXPOG1z0SiSEVkVQpeU51JUBWMEVclQVQ3HitFcU1nkbZUViuQsE4UWmWj4WfLu4B28-zVhGOvOBIXWyh7dFGpOyrzKck54RN_-h-7c5ONrI0WJKBitaBWp9EAp70LwqOvBm076uaak3sddx7jrGHf9EHfk3zxap6bD9kj_zTcCywOwC6P8iUdA-vj9Fh90oqjL_XLUHk_VVvoae_4HgwO-nA</recordid><startdate>20240801</startdate><enddate>20240801</enddate><creator>Hou, Xiaohua</creator><creator>Wang, Jiangbin</creator><creator>Du, Qin</creator><creator>Tian, Dean</creator><creator>Hu, Naizhong</creator><creator>Liu, Deliang</creator><creator>Zhou, Fang</creator><creator>Xie, Li</creator><creator>Gu, Liqun</creator><creator>Kudou, Kentarou</creator><creator>Zhang, Shutian</creator><general>The Pharmaceutical Society of Japan</general><general>Japan Science and Technology Agency</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7QR</scope><scope>7TK</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20240801</creationdate><title>Efficacy and Safety of Vonoprazan-Based Quadruple Therapy for the Eradication of Helicobacter pylori in Patients with Peptic Ulcers: A Pooled Analysis of Two Randomized, Double-Blind, Double-Dummy, Phase 3 Trials</title><author>Hou, Xiaohua ; 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We present a pooled analysis of two randomized, double-blind, double-dummy, phase 3 studies evaluating the efficacy and safety of vonoprazan-based bismuth-containing quadruple therapy for H. pylori eradication. Patients aged ≥18 years with endoscopically confirmed duodenal or gastric ulcers were randomized 1 : 1 to receive vonoprazan 20 mg or lansoprazole 30 mg once daily for up to 6 (duodenal ulcers) or 8 weeks (gastric ulcers). H. pylori–positive patients received vonoprazan- or lansoprazole-based bismuth-containing quadruple therapy for the first 2 weeks. H. pylori eradication was determined using the carbon-13 urea breath test at a follow-up visit 4 weeks post-treatment. The H. pylori eradication rate was 90.6% with vonoprazan vs. 85.2% with lansoprazole (difference: 5.4%; 95% confidence interval (CI): −0.1, 10.8). H. pylori eradication rates were 7.1% (95% CI: 1.4, 12.8) and 12.6% (95% CI: 3.9, 22.0) higher in patients aged <65 years and current smokers, respectively, with vonoprazan vs. lansoprazole. In the Chinese subpopulation, the H. pylori eradication rate was 92.0% with vonoprazan vs. 86.0% with lansoprazole (difference: 6.1%; 95% CI: 0.5, 11.7). Treatment-emergent adverse events occurred in 72.7 vs. 62.6% of H. pylori–positive patients at baseline in the vonoprazan vs. lansoprazole arm. H. pylori eradication with vonoprazan-based quadruple therapy was noninferior to lansoprazole-based quadruple therapy and exceeded 90%, a clinically relevant threshold for determining the efficacy of H. pylori eradication regimens (ClinicalTrials.gov identifier: NCT03050359; NCT03050307).</abstract><cop>Japan</cop><pub>The Pharmaceutical Society of Japan</pub><pmid>39085080</pmid><doi>10.1248/bpb.b24-00011</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Biological and Pharmaceutical Bulletin, 2024/08/01, Vol.47(8), pp.1405-1414 |
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| subjects | Adult Aged Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - therapeutic use Anti-Ulcer Agents - administration & dosage Anti-Ulcer Agents - adverse effects Anti-Ulcer Agents - therapeutic use bismuth-containing quadruple therapy Breath Tests Carbon 13 Clinical trials Double-Blind Method Drug Therapy, Combination Eradication Female Helicobacter Infections - drug therapy Helicobacter Infections - microbiology Helicobacter pylori Helicobacter pylori - drug effects Humans lansoprazole Lansoprazole - administration & dosage Lansoprazole - adverse effects Lansoprazole - therapeutic use Male Middle Aged peptic ulcer Peptic Ulcer - drug therapy Peptic Ulcer - microbiology Peptic ulcers Proton Pump Inhibitors - administration & dosage Proton Pump Inhibitors - adverse effects Proton Pump Inhibitors - therapeutic use Pyrroles - administration & dosage Pyrroles - adverse effects Pyrroles - therapeutic use Sulfonamides - administration & dosage Sulfonamides - adverse effects Sulfonamides - therapeutic use Treatment Outcome Ulcers vonoprazan |
| title | Efficacy and Safety of Vonoprazan-Based Quadruple Therapy for the Eradication of Helicobacter pylori in Patients with Peptic Ulcers: A Pooled Analysis of Two Randomized, Double-Blind, Double-Dummy, Phase 3 Trials |
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