Soichiro Matsuda1, Mototsugu Kato2, Yuko Sakakibara3, Hiroshige Hamada4, Yoshihiro Sasaki5, Hideki Mori6, Yuichiro Hirai6, Shuji Inoue7, Tatsuya Toyokawa8, Takashi Kagaya9, Toshio Kuwai10, Naoki Esaka11, Haruhiro Yamashita12, Noriko Watanabe13, Mio Matsumoto14, Hiroyuki Fujii15, Mamiko Demura16, Kimitoshi Kubo1, Katsuhiro Mabe1, Naohiko Harada17. 1. Department of Gastroenterology, National Hospital Organization Hakodate National Hospital, 18-16, Kawahara-chou, Hakodate, Hokkaido, 041-8512, Japan. 2. Department of Gastroenterology, National Hospital Organization Hakodate National Hospital, 18-16, Kawahara-chou, Hakodate, Hokkaido, 041-8512, Japan. mkato1957@gmail.com. 3. Department of Gastroenterology, National Hospital Organization Osaka National Hospital, Osaka, Japan. 4. Department of Gastroenterology, National Hospital Organization Higashihiroshima Medical Center, Hiroshima, Japan. 5. Department of Gastroenterology, National Hospital Organization Disaster Medical Center, Tokyo, Japan. 6. Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan. 7. Department of Gastroenterology, National Hospital Organization Kochi National Hospital, Kochi, Japan. 8. Department of Gastroenterology, National Hospital Organization Fukuyama Medical Center, Hiroshima, Japan. 9. Department of Gastroenterology, National Hospital Organization Kanazawa Medical Center, Ishikawa, Japan. 10. Department of Gastroenterology, National Hospital Organization Kure Medical Center, Hiroshima, Japan. 11. Department of Gastroenterology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. 12. Department of Gastroenterology, National Hospital Organization Okayama Medical Center, Okayama, Japan. 13. Department of Gastroenterology, National Hospital Organization Mie Chou Medical Center, Mie, Japan. 14. Department of Gastroenterology, National Hospital Organization Hokkaido Medical Center, Hokkaido, Japan. 15. Department of Gastroenterology, National Hospital Organization Fukuokahigashi Medical Center, Fukuoka, Japan. 16. Department of Clinical Research, National Hospital Organization Hakodate National Hospital, Hokkaido, Japan. 17. Department of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Abstract
BACKGROUND: Vonoprazan is a potassium competitive acid blocker used to treat erosive gastroesophageal reflux disease (GERD) with stronger, more stable acid-suppressing effects than proton pump inhibitors (PPIs). This study clarified the usefulness and superiority of vonoprazan administered every second day over PPIs in the maintenance therapy of erosive GERD. METHODS: This is a prospective, multicenter, open-label, two-period randomized cross-over study. Patients were randomized to either the vonoprazan-lansoprazole (VP-LZ) group, who were given vonoprazan 10 mg for the first 4 weeks and then lansoprazole 15 mg for the next 4 weeks both administered once every second day, or the lansoprazole-vonoprazan (LZ-VP) group, who were treated in reverse. GERD symptoms were compared using symptom diaries, the frequency scale for symptoms of GERD (FSSG), and the gastrointestinal symptom rating scale (GSRS). RESULTS: We enrolled 122 patients between December 2017 and May 2019. Symptoms were well controlled in vonoprazan administration and lansoprazole administration were 93.6% and 82.1%, respectively, with a significant difference on McNemar's test (P = 0.003). During the second 4 weeks, 94.4% and 76.7% of patients in the VP-LZ and LZ-VP groups, respectively, were well controlled following for ≥ 6 consecutive days a week (P = 0.009). During the first 4 weeks, 96.7% and 80.0% of patients were well controlled with < 1 weekly in the VP-LZ and LZ-VP groups, respectively, during the first 4 weeks (P = 0.007). GERD symptoms, assessed via FSSG and GSRS, significantly decreased with vonoprazan administration once every second day. CONCLUSIONS: Vonoprazan administered once every second day could be an effective alternative to PPIs in the maintenance treatment of erosive GERD (UMIN000030393).
BACKGROUND: Vonoprazan is a potassium competitive acid blocker used to treat erosive gastroesophageal reflux disease (GERD) with stronger, more stable acid-suppressing effects than proton pump inhibitors (PPIs). This study clarified the usefulness and superiority of vonoprazan administered every second day over PPIs in the maintenance therapy of erosive GERD. METHODS: This is a prospective, multicenter, open-label, two-period randomized cross-over study. Patients were randomized to either the vonoprazan-lansoprazole (VP-LZ) group, who were given vonoprazan 10 mg for the first 4 weeks and then lansoprazole 15 mg for the next 4 weeks both administered once every second day, or the lansoprazole-vonoprazan (LZ-VP) group, who were treated in reverse. GERD symptoms were compared using symptom diaries, the frequency scale for symptoms of GERD (FSSG), and the gastrointestinal symptom rating scale (GSRS). RESULTS: We enrolled 122 patients between December 2017 and May 2019. Symptoms were well controlled in vonoprazan administration and lansoprazole administration were 93.6% and 82.1%, respectively, with a significant difference on McNemar's test (P = 0.003). During the second 4 weeks, 94.4% and 76.7% of patients in the VP-LZ and LZ-VP groups, respectively, were well controlled following for ≥ 6 consecutive days a week (P = 0.009). During the first 4 weeks, 96.7% and 80.0% of patients were well controlled with < 1 weekly in the VP-LZ and LZ-VP groups, respectively, during the first 4 weeks (P = 0.007). GERD symptoms, assessed via FSSG and GSRS, significantly decreased with vonoprazan administration once every second day. CONCLUSIONS: Vonoprazan administered once every second day could be an effective alternative to PPIs in the maintenance treatment of erosive GERD (UMIN000030393).