Efficacy of Standard Triple Therapy With or Without Statin in Helicobacter pylori Eradication: A Randomized Double-Blind Placebo-Controlled Trial.

Background

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Aims

Standard triple therapy (STT) for Helicobacter pylori (H. pylori) infection has become suboptimal. Atorvastatin may improve eradication rates by promoting autophagy and reducing inflammation. This study aimed to evaluate the efficacy and safety of adjuvant atorvastatin with STT compared to STT alone for H. pylori eradication.

Methods

In this randomized, placebo-controlled trial, 138 treatment-naïve patients with H. pylori infection were randomized to two groups. The intervention group (n = 70) received a 14-day regimen of omeprazole, amoxicillin, clarithromycin, and atorvastatin (40 mg once daily). The control group (n = 68) received the same regimen with a matching placebo. The primary endpoint was H. pylori eradication, assessed by a urea breath test 4-6 weeks after treatment completion. Secondary endpoints included CYP2C19 and CYP3A4/5 genotypes, adverse events, and patient compliance.

Results

The eradication rate in the intervention group was significantly higher than in the control group in both the per-protocol (97.1% vs. 85.3%) and intention-to-treat (ITT) analyses (95.7% vs. 85.3%). The absolute risk difference for the ITT analysis was 10.4% (95% CI, 0.75 to 20.1; p = 0.03). The distribution of CYP2C19 and CYP3A4/5 genotypes was similar between groups. No clinically significant differences in adverse events were observed.

Conclusion

Adjuvant therapy with atorvastatin combined with STT significantly improved H. pylori eradication rates without clinically significant adverse events. Further randomized controlled trials in diverse populations and with varying antibiotic resistance patterns are needed to better clarify the effects of statins on H. pylori treatment. TRIAL REGISTRATION Thai Clinical Trial Registry, No. TCTR20220201001.