First Interim Analysis of Patient-Reported Outcomes in View Study: A Multicenter, Single-Arm, Prospective, Non-Interventional Study of Vonoprazan in Real-World Clinical Practice in China
Author(s)
Xiao Y1, Wang Q2, Li G3, Nail A4, Song Q5, Xie L6, Chen M7
1The First Affiliated Hospital, Sun Yat-Sen University,, Guangzhou, Guangdong, China, 2Qilu Hospital of Shandong University, Qingdao, Shandong, China, 3The Affiliated Hospital of Hangzhou Normal University,, Hangzhou, Zhejiang, China, 4Takeda Pharmaceutical Company, Cambridge, MA, USA, 5Takeda Pharmaceutical Company, Shanghai, China, 6Takeda Pharmaceutical Company, Beijing, China, 7The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
Presentation Documents
OBJECTIVES: To evaluate changes in the quality of sleep and life of Chinese patients diagnosed with reflux esophagitis (RE) when treated with vonoprazan in real-world clinical practice.
METHODS: VIEW is a multicenter, single-arm, prospective, observational study (NCT04501627). Enrolled patients were ≥18 years and were treated with 20 mg vonoprazan QD for 4 weeks (8 weeks if insufficient healing). The effectiveness of vonoprazan (overall and for patients ≥65 years) was assessed using changes from baseline to week-4 in PRO scores: Pittsburgh Sleep Quality Index (PSQI, for sleep quality and patterns); the EuroQol 5-Dimension 5-Level (EQ-5D-5L, for quality of life); and the EQ-Visual Analogue Scale (EQ-VAS; for health status). Negative differences in PSQI and positive differences in EQ-5D-5L and EQ-VAS scores represent an improvement.
RESULTS: Of 1012 patients enrolled, 419 patients had a PSQI score at both baseline and week-4, and the mean±SD (95% CI) of the differences in the two scores was -0.6±2.27 (-0.83, -0.40). For 63 patients ≥65 years, the mean±SD difference was -0.5±2.47(-1.15, 0.10). The percentage (95% CI) of patients with poor sleep quality (global score >5) in the overall population decreased from 43.2% (39.01, 47.45) at baseline to 32.3% (27.88, 36.88) at week-4. In the ≥65 years age-group, this percentage decreased from 51.9% (40.36, 63.29) to 45.5% (33.14, 58.19). For 451 patients with EQ-5D-5L index scores at both baseline and week-4, the mean±SD of the differences was 0.028±0.0732 (0.0217, 0.0353). For 70 patients ≥65 years, the mean±SD of the differences was 0.041±0.072 (0.0242, 0.0587). For 452 patients with EQ-VAS scores at both baseline and week-4, the mean±SD of the differences was 5.1±11.52 (4.06, 6.19), while in 70 patients ≥65 years, the mean±SD of the differences was 8.5±14.69 (4.97, 11.97).
CONCLUSIONS: Vonoprazan treatment in real-world clinical practice improved both sleep quality and quality of life of Chinese patients diagnosed with RE.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
PCR5
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Drugs, Gastrointestinal Disorders