Symptom Relief With Vonoprazan Treatment in Gastroesophageal Reflux Disease Patients With Diabetes in China: Post Hoc Analysis of the VIEW Study
Author(s)
Yinglian Xiao, PhD1, Kailun Liang, MSc2, Fang Zhou, MSc2, Minhu Chen, PhD1.
1The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China, 2Takeda Pharmaceutical Company, Shanghai, China.
1The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China, 2Takeda Pharmaceutical Company, Shanghai, China.
OBJECTIVES: Patients with diabetes are at greater risk of gastroesophageal reflux disease (GERD) than those without diabetes. Proton pump inhibitors (PPIs) are prescribed to treat GERD; however, the risk of PPI therapy failure is high in GERD patients with diabetes. Thus, the effectiveness of vonoprazan, a novel potassium-competitive acid blocker, for symptom relief among GERD patients with diabetes was assessed.
METHODS: VIEW (NCT04501627) was a multicenter, single-arm, prospective, observational, real-world study conducted in China. Enrolled patients received 20 mg of vonoprazan once daily for 4 weeks (8 weeks if insufficient benefit). This post hoc analysis evaluated changes in symptom scores (recorded via patients’ symptom diaries) from baseline during the first 14 days of treatment in GERD patients with diabetes. A mixed-effects model was utilized for repeated measures analysis, and changes in least-squares mean (LSM) symptom scores were reported (negative values indicate improvement).
RESULTS: Of the 2214 patients in the effectiveness analysis population for GERD, 106 (4.8%) had diabetes. The LSM change in symptom scores from baseline to Day 14 demonstrated a significant improvement in all-day heartburn and regurgitation (−1.44 [95% confidence interval {CI}: −1.68, −1.20]; P<0.001), nighttime heartburn (−1.40 [95% CI: −1.61, −1.14]; P<0.001), and nighttime regurgitation (−1.20 [95% CI: −1.45, −1.02]; P<0.001) in GERD patients with diabetes. The cumulative percentage of GERD patients with diabetes who experienced complete symptom relief (symptom score=0) from heartburn and regurgitation, nighttime heartburn, and nighttime regurgitation increased from 22.2% to 63.9%, 39.6% to 72.9%, and 41.2% to 70.6%, from Day 1 to Day 14, respectively. Among patients who had both heartburn and regurgitation at baseline, the rates of symptom relief from first heartburn and regurgitation were 37%, 59.3%, and 77.8% by Days 3, 7, and 14, respectively.
CONCLUSIONS: This study demonstrated effective symptom relief with vonoprazan treatment in GERD patients with diabetes.
METHODS: VIEW (NCT04501627) was a multicenter, single-arm, prospective, observational, real-world study conducted in China. Enrolled patients received 20 mg of vonoprazan once daily for 4 weeks (8 weeks if insufficient benefit). This post hoc analysis evaluated changes in symptom scores (recorded via patients’ symptom diaries) from baseline during the first 14 days of treatment in GERD patients with diabetes. A mixed-effects model was utilized for repeated measures analysis, and changes in least-squares mean (LSM) symptom scores were reported (negative values indicate improvement).
RESULTS: Of the 2214 patients in the effectiveness analysis population for GERD, 106 (4.8%) had diabetes. The LSM change in symptom scores from baseline to Day 14 demonstrated a significant improvement in all-day heartburn and regurgitation (−1.44 [95% confidence interval {CI}: −1.68, −1.20]; P<0.001), nighttime heartburn (−1.40 [95% CI: −1.61, −1.14]; P<0.001), and nighttime regurgitation (−1.20 [95% CI: −1.45, −1.02]; P<0.001) in GERD patients with diabetes. The cumulative percentage of GERD patients with diabetes who experienced complete symptom relief (symptom score=0) from heartburn and regurgitation, nighttime heartburn, and nighttime regurgitation increased from 22.2% to 63.9%, 39.6% to 72.9%, and 41.2% to 70.6%, from Day 1 to Day 14, respectively. Among patients who had both heartburn and regurgitation at baseline, the rates of symptom relief from first heartburn and regurgitation were 37%, 59.3%, and 77.8% by Days 3, 7, and 14, respectively.
CONCLUSIONS: This study demonstrated effective symptom relief with vonoprazan treatment in GERD patients with diabetes.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO223
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
Gastrointestinal Disorders