"Vonoprazan improves the efficacy of bismuth quadruple therapy containi" by Tianlian Yan, Jinghua Wang et al.
 

Vonoprazan improves the efficacy of bismuth quadruple therapy containing doxycycline and metronidazole as first-line Helicobacter pylori treatment in penicillin-allergic patients: a randomized controlled trial

Tianlian Yan, Department of Gastroenterology, Zhejiang Provincial Clinical Research Center for Digestive Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Jinghua Wang, Department of Gastroenterology, Zhejiang Provincial Clinical Research Center for Digestive Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Renke Zhu, Department of Gastroenterology, Zhejiang Provincial Clinical Research Center for Digestive Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Dan Ma, Department of Gastroenterology, Zhejiang Provincial Clinical Research Center for Digestive Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Jianguo Gao, Department of Gastroenterology, Zhejiang Provincial Clinical Research Center for Digestive Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Jiewei Wang, Department of Gastroenterology, Zhejiang Provincial Clinical Research Center for Digestive Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Ye Chen, Department of Mathematics and Statistics, Northern Arizona University, Flagstaff, AZ 86011, USA.
Kefang Sun, Rochester Regional HealthFollow
Qing Gu, Department of Endoscopy Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
Lan Li, Department of Gastroenterology, Zhejiang Provincial Clinical Research Center for Digestive Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.

Department

Internal Medicine

Document Type

Article

Publication Title

The Journal of Antimicrobial Chemotherapy

Abstract

Background: Helicobacter pylori eradication in penicillin-allergic patients presents challenges. Options of effective regimens are lacking in areas where tetracycline is unavailable.

Objectives: To evaluate the efficacy of replacing the proton pump inhibitor (PPI) with a potassium-competitive acid blocker (P-CAB, vonoprazan) in standard bismuth quadruple therapy containing doxycycline and metronidazole as a first-line treatment for H. pylori.

Methods: This prospective randomized clinical trial enrolled 332 naive patients with H. pylori infection and penicillin allergy. Participants were randomly assigned in a 1:1 ratio to either the 14 day P-CAB/BDM group (vonoprazan 20 mg twice daily, colloidal bismuth 200 mg twice daily, doxycycline 100 mg twice daily and metronidazole 400 mg three times daily) or the 14 day PPI/BDM group (rabeprazole 10 mg twice daily, and the same dose of the three other drugs as in the 14 day P-CAB/BDM group).

Results: Eradication rates in the P-CAB/BDM and PPI/BDM groups were 90.4% and 71.1% (P value for superiority was 0.013), respectively, by ITT analysis. The efficacy of P-CAB/BDM remained non-inferior and even superior to PPI/BDM therapy in all ITT, modified ITT and PP analyses. The overall frequency of adverse events (39.8% and 40.4%; P = 0.911) and compliance (88.0% and 91.0%; P = 0.372) were similar between P-CAB and PPI regimens. Patients with higher body surface area were significantly associated with eradication failure in both groups (P < 0.05).

Conclusions: The 14 day P-CAB/BDM therapy provided a satisfactory eradication rate of > 90% (ITT analysis) and had a good safety profile as first-line H. pylori therapy, providing an alternative option for penicillin-allergic patients.

First Page

927

Last Page

934

DOI

10.1093/jac/dkae467

Volume

80

Issue

4

Publication Date

4-2-2025

Medical Subject Headings

Humans; Male; Helicobacter Infections (drug therapy); Female; Middle Aged; Metronidazole (therapeutic use, administration & dosage, adverse effects); Sulfonamides (therapeutic use, administration & dosage, adverse effects); Drug Therapy, Combination; Bismuth (therapeutic use, administration & dosage, adverse effects); Prospective Studies; Treatment Outcome; Helicobacter pylori (drug effects); Adult; Anti-Bacterial Agents (therapeutic use, administration & dosage, adverse effects); Drug Hypersensitivity; Pyrroles (administration & dosage, adverse effects, therapeutic use); Penicillins (therapeutic use, administration & dosage, adverse effects); Aged; Doxycycline (therapeutic use, administration & dosage, adverse effects); Proton Pump Inhibitors (administration & dosage, therapeutic use, adverse effects); Young Adult

PubMed ID

40048654

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