KEY TAKEAWAYS
- The VIEW observational trial aimed to assess vonoprazan’s impact on QoL and sleep in Chinese patients with reflux esophagitis, including the elderly.
- The study found improved sleep quality and life for Chinese reflux esophagitis patients using vonoprazan.
Xiao Y and the team aimed to assess how vonoprazan affects the quality of life (QoL) and sleep in Chinese patients with reflux esophagitis (RE), including the elderly.
The VIEW study, a multicenter, single-arm, prospective, non-interventional investigation (NCT04501627), involved Chinese patients aged 18 years and above. They were treated with 20 mg vonoprazan once daily for 4 weeks (extended to eight weeks if insufficient healing), followed by a two-week safety follow-up period.
This final analysis examined changes in patient-reported outcomes (PRO) from baseline to week four, both overall and among elderly reflux esophagitis patients. Improvement was indicated by a negative difference in PSQI score and positive differences in EQ-5D-5L and EQ-VAS scores.
About 1796 patients participated in the study, including 250 elderly individuals aged 65 years and older. 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). In the overall population, the percentage (95% CI) of patients reporting poor sleep quality decreased from 41.9% (39.57, 44.29) at baseline to 32.7% (30.27, 35.24) at week 4.
Among elderly patients, this percentage decreased from 53.2% (46.59, 59.71) to 45.3% (38.26, 52.43) during the same period. 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. The mean±SD (95% CI) changed 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) changed 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 the overall population and -0.1 ±0.62 (-0.23, -0.07) and -0.4 ±0.83 (-0.47, -0.24) respectively in elderly patients.
The study concluded that Chinese reflux esophagitis patients treated with vonoprazan in real-world clinical practice experienced improvements in both quality of sleep and life.
The trial was sponsored by the Takeda.
Source: https://www.ispor.org/heor-resources/presentations-database/presentation/intl2024-3898/134741
Clinical Trial: https://clinicaltrials.gov/study/NCT04501627
Xiao Y, Xue Z, Zhang Z, et al. (2024). “Patient Reported Outcomes of Vonoprazan in Chinese Reflux Esophagitis Patients: A Prospective Real-World Study.” Presented at ISPOR 2024, Atlanta, GA, USA, Value in Health, Volume 27, Issue 6, S1 (June 2024) (CO166).