Patient Reported Outcomes of Vonoprazan in Chinese Reflux Esophagitis Patients: A Prospective Real-World Study
Author(s)
Xiao Y1, Xue Z2, Zhang Z3, Nail A4, Song Q5, Xie L6, Chen M7
1The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China, 2The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China, 3Nanjing First Hospital, Nanjing, Jiangsu, China, 4Takeda Pharmaceutical Company, Cambridge, MA, USA, 5Takeda (China) International Trade Co., Ltd, Shanghai, China, 6Takeda (China) International Trade Co., Ltd, Shanghai, Shanghai, China, 7The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Presentation Documents
OBJECTIVES:
To evaluate the effectiveness of vonoprazan in quality of life (QoL) and sleep for Chinese reflux esophagitis (RE) patients treated with vonoprazan in real-world clinical practice: in overall patient population and in elderly (≥65 years) patients’ subgroup.METHODS:
VIEW is a multicenter, single-arm, prospective, non-interventional study (NCT04501627) that enrolled Chinese patients ≥18 years treated with 20-mg vonoprazan QD for 4 weeks (8 weeks if insufficient healing) with 2-week safety follow-up. This final analysis assessed changes from baseline to week-4 in patient-reported outcomes for overall and for elderly RE patients. Negative difference in PSQI score and positive differences in EQ-5D-5L and EQ-VAS scores represented improvement.RESULTS:
Overall, 1796 patients were enrolled of whom 250 were elderly patients (aged ≥65 years). The mean±SD (95% CI) change in PSQI global score from baseline to week-4 was calculated for 1360 patients; -0.7±2.31 (-0.79, -0.55) and for 189 elderly patients; -0.5±2.46 (-0.90, -0.19). The percentage (95% CI) of patients with poor sleep quality decreased from 41.9% (39.57, 44.29) at baseline to 32.7% (30.27, 35.24) at week-4 in overall population and from 53.2% (46.59, 59.71) to 45.3% (38.26, 52.43) in elderly patients. The mean±SD (95% CI) change from baseline to week-4 in EQ-5D-5L (n=1443) and EQ-VAS scores (n=1454) was 0.029±0.0809 (0.0251, 0.0335) and 4.5±11.28 (3.87, 5.03) respectively. Among elderly patients, mean±SD (95% CI) change from baseline to week-4 in EQ-5D-5L score (n=205) was 0.033±0.0845 (0.0218, 0.0451) and in EQ-VAS score (n=208) was 4.7±12.77 (2.98, 6.47). The mean±SD (95% CI) change from baseline to week-4 in anxiety/depression and pain/discomfort scores was -0.2±0.63 (-0.20, -0.13) and 0.3±0.77 (-0.34, -0.26), respectively in overall population and -0.1 ±0.62 (-0.23, -0.07) and -0.4 ±0.83 (-0.47, -0.24) respectively in elderly patients.CONCLUSIONS:
Chinese RE patients treated with vonoprazan in real-world clinical practice experienced improvements in both quality of sleep and life.Conference/Value in Health Info
Value in Health, Volume 27, Issue 6, S1 (June 2024)
Code
CO166
Topic
Patient-Centered Research
Topic Subcategory
Adherence, Persistence, & Compliance, Patient Behavior and Incentives, Patient-reported Outcomes & Quality of Life Outcomes, Stated Preference & Patient Satisfaction
Disease
Drugs, Gastrointestinal Disorders