Vonoprazan-Based Regimen Is More Useful than PPI-Based One as a First-Line<i>Helicobacter pylori</i>Eradication: A Randomized Controlled Trial

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  • Masafumi Maruyama
    Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan
  • Naoki Tanaka
    Department of Metabolic Regulation, Shinshu University Graduate School of Medicine, Matsumoto, Japan
  • Daisuke Kubota
    Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan
  • Masayuki Miyajima
    Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan
  • Takefumi Kimura
    Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan
  • Koujiro Tokutake
    Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan
  • Ryujiro Imai
    Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan
  • Toru Fujisawa
    Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan
  • Hiromitsu Mori
    Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan
  • Yoshiaki Matsuda
    Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan
  • Shuichi Wada
    Department of Gastroenterology, Nagano Red Cross Hospital, Nagano, Japan
  • Akira Horiuchi
    Digestive Disease Center, Showa Inan General Hospital, Komagane, Japan
  • Kendo Kiyosawa
    Department of Gastroenterology, Aizawa Hospital, Matsumoto, Japan

説明

<jats:p><jats:italic>Background</jats:italic>. A new agent, potassium-competitive acid blocker vonoprazan (VPZ) has potent acid-inhibitory effects and may offer advantages over conventional<jats:italic>H. pylori</jats:italic>eradication therapies. We aimed to compare the eradication rate between VPZ-based treatment and PPI-based one.<jats:italic>Methods</jats:italic>. This randomized controlled trial was designed to assign 141 patients with<jats:italic>H. pylori-</jats:italic>positive gastritis to VPZ group (VPZ 20 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days) or PPI group (rabeprazole 20 mg or lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days). Primary endpoints were eradication rates and adverse events.<jats:italic>Results</jats:italic>. Seventy of 72 patients in VPZ group and 63 of 69 patients in PPI group completed the treatment after 7 days. The eradication rate was significantly higher in VPZ group than PPI group by intention-to-treat analysis (95.8% versus 69.6%,<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M1"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn fontstyle="italic">0.0000</mml:mn><mml:mn fontstyle="italic">3</mml:mn></mml:math>, 95% confidence interval [CI] 88.3-99.1% versus 57.3-80.1%) and per-protocol analysis (95.7% versus 71.4%,<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M2"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn fontstyle="italic">0.0002</mml:mn></mml:math>, 95% CI 88.0-99.1% versus 58.7-82.1%). The incidence of adverse events was not different between the groups (26.3% in VPZ group versus 37.7% in PPI group,<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M3"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn fontstyle="italic">0.15</mml:mn></mml:math>).<jats:italic>Conclusion</jats:italic>. VPZ-based regimen is more useful than that PPI-based regimen as a first-line<jats:italic>H. pylori</jats:italic>eradication therapy.</jats:p>

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