According to a recent study, vonoprazan-amoxicillin dual therapy achieved an 87.14% eradication rate for Helicobacter pylori in patients with type 2 diabetes, and successful eradication significantly reduced glycated hemoglobin levels.
Researchers conducted a prospective, single-center clinical trial to evaluate the safety and efficacy of a 14-day vonoprazan-amoxicillin (VA) dual therapy regimen for H. pylori eradication in patients with type 2 diabetes mellitus (T2DM). In the study, published in Scientific Reports, the researchers also investigated the impact of H. pylori eradication on glycated hemoglobin (A1C) levels.
Seventy-five patients with T2DM and confirmed H. pylori infections were enrolled and treated with vonoprazan (20 mg, twice daily) and amoxicillin (750 mg, thrice daily) for a period of 14 days. H. pylori eradication was assessed using the 13C-urea breath test at least 4 weeks posttreatment. A1C levels were measured at baseline and 3 months following therapy. The intention-to-treat analysis showed an eradication rate of 84.0% (n = 63/75), whereas the per-protocol analysis demonstrated an eradication rate of 87.14% (n = 61/70).
Using multivariate logistic regression, lead study author Jie Zhang of the Department of Endocrinology at the Affiliated Changzhou No. 2 People’s Hospital of Nanjing Medical University at the Changzhou Medical Center of Nanjing Medical University in Changzhou, China, and colleagues identified smoking (odds ratio [OR] = 4.59, 95% confidence interval [CI] = 1.20–17.58, P = .026) and elevated baseline A1C levels (OR = 1.65, 95% CI = 1.01–2.68, P = .044) as independent risk factors for eradication failure. The patients who achieved successful eradication experienced a significant reduction in A1C levels 3 months posttreatment (7.70 ± 1.05% to 7.23 ± 1.00%, P = .006). However, this decrease was not observed in patients with failed eradication.
Adverse events—including nausea (n = 2), abdominal pain (n = 2), diarrhea (n = 2), and rashes (n = 1)—were reported in 13.3% of the patients. Most events were mild and resolved without intervention. Compliance was high: 93.3% of the patients consumed at least 80% of the prescribed medication. No significant changes in liver or kidney function were observed.
This study was limited by its single-center, single-arm design and the absence of antibiotic susceptibility testing, which prevented the evaluation of resistance impact on the 14-day VA dual therapy. Additional limitations included the lack of amoxicillin absorption tests in patients with diabetes, the need for closer monitoring of bilirubin levels, and the unaccounted influence of factors such as diet, exercise, and medication on A1C levels.
While VA dual therapy achieved high eradication rates in patients with T2DM, and smoking and poor glycemic control were identified as key risk factors for eradication failure, the researchers suggested further multicenter trials to confirm the findings.
Full disclosures can be found in the published study.