Exploratory Study on Efficacy and Safety of Minocycline-Based Dual Therapy for Helicobacter pylori Eradication.

BACKGROUND & AIMS: This study aimed to evaluate the feasibility of vonoprazan-minocycline (VM) dual therapy for Helicobacter pylori infection.

METHODS

In this open-label RCT, 120 H. pylori-infected patients (60 treatment-naïve and 60 treatment-failure cases) were randomized to receive vonoprazan-amoxicillin dual therapy (VA: vonoprazan 20 mg b.i.d. + amoxicillin 1.0 g t.i.d., control group) or VM dual therapy (vonoprazan 20 mg b.i.d. + minocycline 100 mg b.i.d., test group) for 14 days. The primary outcome was eradication rates. Secondary outcomes included adverse effects (AEs).

RESULTS

As first-line treatment, eradication rates were 96.7% (VA) vs. 90.0% (VM) in intention-to-treat (ITT) analysis (p = 0.30) and 96.7% (VA) vs. 96.4% (VM) in per-protocol (PP) analysis (p = 0.96). For rescue treatment, eradication rates were 86.7% (VA) vs. 76.7% (VM) in ITT (p = 0.32) and 89.7% (VA) vs. 79.3% (VM) in PP (p = 0.28). Overall eradication rates were 91.7% (VA) vs. 83.3% (VM) in ITT (p = 0.17) and 93.2% (VA) vs. 87.7% (VM) in PP (p = 0.31). VM had a higher incidence of AEs than VA (30.0% vs. 10.0%, p = 0.006), with dizziness being the most common (18.3%).

CONCLUSIONS

VM dual therapy was shown to be an effective and safe treatment option, demonstrating comparable eradication rates to VA dual therapy. While VM had a slightly higher incidence of AEs, they were generally mild and manageable. VM remained a valuable alternative for patients with penicillin allergies or amoxicillin resistance.