Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication

Second Affiliated Hospital, School of Medicine, Zhejiang University558 enrolled

Overview

The primary objective of this retrospective study was to assess the efficacy and safety of a bismuth quadruple regimen of a low-dose potassium-competitive acid blocker versus a standard-dose potassium-competitive acid blocker and a standard-dose proton pump inhibitor combined with amoxicillin and clarithromycin as the initial treatment of Helicobacter pylori infection.

Helicobacter pylori (H. pylori) infection is closely associated with a variety of diseases including chronic gastritis, peptic ulcer, and gastric cancer. Adequate acid suppression is essential for H. pylori eradication therapy. Potassium-competitive acid blocker (P-CAB) vonoprazan (VPZ) has faster, stronger, and longer-lasting acid inhibition and plays an important role in H. pylori treatment. 2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment recommended for the first time a quadruple regimen of bismuth containing P-CAB for H. pylori eradication, in which P-CAB was administered as VPZ 20 mg twice daily. In this retrospective study, we compared the efficacy and safety of a quadruple regimen based on low-dose P-CAB (VPZ 20 mg once daily) versus a quadruple regimen based on standard-dose P-CAB (VPZ 20 mg twice daily) or standard-dose proton pump inhibitor (rabeprazole 10 mg twice daily) containing amoxicillin, clarithromycin, and bismuth as initial treatment for H. pylori infection. Our study will provide clinical evidence for the necessary dosage of VPZ in bismuth quadruple regimens, which will help to further optimize the treatment regimen for H. pylori infection.

Study Type

OBSERVATIONAL

Enrollment

558

Conditions

Helicobacter Pylori Infection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of H. pylori infection confirmed by urea breath test, monoclonal fecal antigen test, endoscopic biopsy histopathology, or bacterial culture; 2. No previous eradication therapy for H. pylori; 3. Age and gender are not restricted. Exclusion Criteria: 1. Use of acid-suppressing drugs within 2 weeks prior to treatment, or use of bismuth or antibiotics (including herbal medicines with antimicrobial properties) within 4 weeks prior to treatment; 2. Known hypersensitivity to the drugs used in this study; 3. History of esophageal or gastric surgery; 4. Pregnant or lactating women; 5. Serious systemic diseases, diseases of the heart, lungs, brain and other vital organs, hepatic or renal insufficiency or malignant tumors (except gastric cancer); 6. Patients unable to express their main complaints.

Outcomes

Primary Outcomes

Helicobacter H. pylori eradication rate

number of patients successfully eradicated / the total number participants

Time frame: after eradication therapy at least 4 weeks

Secondary Outcomes

safety of regimens

comparison of the incidence of adverse events in each group

Time frame: Within 4 weeks from the beginning to the end of therapy

compliance

percentage of correctly administered drugs

Time frame: 4 weeks after therapy completion

Central Contacts

Qin DU

CONTACT

+86 0571-89713734 duqin@zju.edu.cn

Data from ClinicalTrials.gov

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