Clinical Study on the Eradication of Helicobacter pylori by Vonoprazan Combined with Amoxicillin for 10-Day Dual Therapy

Clin Pharmacol Drug Dev. 2024 Mar;13(3):240-247. doi: 10.1002/cpdd.1357. Epub 2024 Jan 10.

Abstract

Vonoprazan holds significant research promise for Helicobacter pylori eradication, with the goal of determining the most effective drug regimen. In this study, H. pylori patients (426) were enrolled and randomized into 3 groups: an EA14 group (20 mg of esomeprazole qid and 1000 mg of amoxicillin tid for 14 days), a VA14 group (20 mg of vonoprazan bid and 750 mg of amoxicillin qid for 14 days), and a VA10 group (20 mg of vonoprazan bid and 1000 mg of amoxicillin tid for 10 days). Key outcomes encompassed the H. pylori eradication rate, patient adverse effects, and compliance. In the EA14, VA14, and VA10 groups, H. pylori eradication rates were 89.4%, 90.1%, and 88.7% in intention-to-treat analysis, and 94.2%, 94.4%, and 94.6% in per-protocol analysis, respectively. Adverse events incidences were 14.8%, 12.7%, and 5.6%, while compliance rates were 88.7%, 90.9%, and 95.8%, respectively. Notably, the VA10 regimen demonstrated comparable H. pylori eradication rates, adverse effect incidences, and compliance levels to the EA14 and VA14 regimens.

Keywords: H. pylori eradication rate; Helicobacter pylori; adverse effects; amoxicillin; dual therapy; intention-to-treat analysis; per-protocol analysis; vonoprazan.

MeSH terms

  • Amoxicillin / adverse effects
  • Helicobacter Infections* / chemically induced
  • Helicobacter Infections* / drug therapy
  • Helicobacter pylori*
  • Humans
  • Metronidazole / adverse effects
  • Proton Pump Inhibitors / adverse effects
  • Pyrroles*
  • Sulfonamides*

Substances

  • Amoxicillin
  • 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
  • Proton Pump Inhibitors
  • Metronidazole
  • Pyrroles
  • Sulfonamides