Journal of digestive diseases · 2026
Real-World Safety of Vonoprazan in Patients and Symptom Outcomes in Patients With Reflux Esophagitis in China: A Prospective, Non-Interventional Study (VIEW).
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Xiao Ying Lian, Yang Hui, Lu Yi Xia, Yang Li, Zhang Guo Xin, Ye Guo Liang, Song Qi, Xie Li, Chen Min Hu
Аннотация
OBJECTIVES: Vonoprazan was approved in China for reflux esophagitis (RE) in 2019; however, its real-world safety and effectiveness remain undetermined. We aimed to evaluate the safety of vonoprazan in patients and its effectiveness in patients with RE in a real-world setting.
METHODS: In this prospective, non-interventional, real-world study, vonoprazan 20 mg was administered orally daily for 4 or 8 weeks. Primary endpoints were incidence rates of adverse events (AEs), serious AEs (SAEs), and adverse drug reactions (ADRs). Secondary endpoints included proportions of patients with RE without typical gastroesophageal reflux disease (GERD) symptoms (complete symptom relief) at baseline and Week 4, relief of heartburn/regurgitation symptoms (all day/nighttime) during Week 1, and mean change in GERD Questionnaire (GERDQ) score at Week 4.
RESULTS: Of the 2829 patients with safety data, 488 (17.2%) reported ≥ 1 AE; 29 (1.0%) reported ≥ 1 SAE; and 129 (4.6%) reported ≥ 1 ADR. Of 1796 patients with RE and effectiveness data, the proportion without typical symptoms of GERD increased from 20.1% (95% confidence interval [CI] 18.29-22.05) at baseline to 55.2% (95% CI 52.63-57.79) at Week 4 (change: 35.1%, 95% CI 31.95-38.25). Complete relief from heartburn, nighttime heartburn, regurgitation, and nighttime regurgitation was observed in 32.3% (314/971), 43.8% (427/975), 27.0% (262/971), and 40.5% (395/976) patients, respectively, during Week 1. Mean change in GERDQ score (n = 1464) improved by Week 4 (-1.70).
CONCLUSION: Vonoprazan is well tolerated through 8 weeks in patients and improves symptoms in patients with RE in the real-world setting in China (VIEW; NCT04501627).
METHODS: In this prospective, non-interventional, real-world study, vonoprazan 20 mg was administered orally daily for 4 or 8 weeks. Primary endpoints were incidence rates of adverse events (AEs), serious AEs (SAEs), and adverse drug reactions (ADRs). Secondary endpoints included proportions of patients with RE without typical gastroesophageal reflux disease (GERD) symptoms (complete symptom relief) at baseline and Week 4, relief of heartburn/regurgitation symptoms (all day/nighttime) during Week 1, and mean change in GERD Questionnaire (GERDQ) score at Week 4.
RESULTS: Of the 2829 patients with safety data, 488 (17.2%) reported ≥ 1 AE; 29 (1.0%) reported ≥ 1 SAE; and 129 (4.6%) reported ≥ 1 ADR. Of 1796 patients with RE and effectiveness data, the proportion without typical symptoms of GERD increased from 20.1% (95% confidence interval [CI] 18.29-22.05) at baseline to 55.2% (95% CI 52.63-57.79) at Week 4 (change: 35.1%, 95% CI 31.95-38.25). Complete relief from heartburn, nighttime heartburn, regurgitation, and nighttime regurgitation was observed in 32.3% (314/971), 43.8% (427/975), 27.0% (262/971), and 40.5% (395/976) patients, respectively, during Week 1. Mean change in GERDQ score (n = 1464) improved by Week 4 (-1.70).
CONCLUSION: Vonoprazan is well tolerated through 8 weeks in patients and improves symptoms in patients with RE in the real-world setting in China (VIEW; NCT04501627).