Introduction
Symptom relief is the key treatment goal of gastroesophageal reflux disease (GERD). Vonoprazan, a potassium-competitive acid blocker approved in China, was superior in potency and duration of action versus conventional proton pump inhibitors in preclinical studies.1 However, there are limited real-world data on the effectiveness and safety of vonoprazan in adult Chinese patients.
Aims & Methods
VIEW (NCT04501627) was a multicentre, single-arm, prospective, observational, real-world study conducted in China. Patients received 20 mg vonoprazan, orally, once daily for 4 weeks (8 weeks for insufficient healing), followed by a safety assessment of 2 weeks. In this post hoc subgroup analysis of patients with GERD, effectiveness was assessed, including changes in GERD-typical symptoms, GERD questionnaire (GerdQ) scores and complete relief in patients’ symptom diary.
Results
Among the 2214 patients included in the effectiveness analysis population of the GERD group, 86.7% were aged <65 years and 60.8% were male. Among evaluable patients with all-day heartburn (n=672) and all-day regurgitation (n=728) at baseline, 49.7% (95% confidence interval [CI], 45.9-53.6) and 40.8% (95% CI, 37.2-44.5), respectively, achieved complete symptom relief during the first 2 weeks of treatment. The reduction from baseline in all-day heartburn and regurgitation was significant (P<0.001) on days 1 through 14 of treatment. Among evaluable patients with night-time heartburn (n=746) and night-time regurgitation (n=816) at baseline, complete symptom relief was achieved in 59.9% (95% CI, 56.3-63.5) and 52.8% (95% CI, 49.3-56.3) of patients, respectively, during the first 2 weeks of treatment. The reduction from baseline in night-time heartburn and regurgitation was significant (P<0.001) on days 1 through 14 of treatment. The mean (standard deviation) overall GerdQ score improvement from baseline to week 4 was -1.6 (2.8). The percentage of patients without GERD-typical symptoms increased by 33.5% (95% CI, 30.7-36.3) from baseline to week 4. Symptoms of heartburn, regurgitation and sleep difficulties due to heartburn/regurgitation, and the need for additional medication generally reduced at week 4 compared with that at baseline (Table). Adverse events (AEs; any grade) were reported in 17.4% of patients in the safety population (N=2307), with the most common (>5%) being gastrointestinal disorders (8.3%). Overall, 0.9% of patients had ≥1 AE leading to study discontinuation. No AEs led to death.
Table: Improvement in symptom frequency score and additional medication usage from baseline to week 4 following vonoprazan treatment
Symptom frequency score
| Evaluable patients, n
| Valuea
|
|---|
BL, baseline; CI, confidence interval; SD, standard deviation; W, week.
aNegative values indicate improvement.
bExamples: TUMS, Rolaids, Maalox. |
Mean (SD) change in heartburn from BL to W4
| 1811
| -0.8 (1.25)
|
95% CI for Mean
| - | (-0.88, -0.76)
|
Mean (SD) change in regurgitation from BL to W4
| 1809 | -0.8 (1.22)
|
95% CI for Mean
| - | (-0.83, -0.72)
|
Mean (SD) change in sleep difficulty due to heartburn/regurgitation from BL to W4
| 1809 | -0.6 (1.08)
|
95% CI for Mean
| - | (-0.63, -0.53)
|
Mean (SD) change in the need for additional medicationb for heartburn/regurgitation from BL to W4
| 1808 | -0.4 (1.02) |
95% CI for Mean
| - | (-0.40, -0.30)
|
Conclusion
This real-world subgroup analysis of Chinese patients with GERD demonstrated that vonoprazan effectively relieved symptoms, improved GerdQ scores and reduced the need for additional medications while maintaining an acceptable safety profile.
References
1. Matsukawa J, Inatomi N, Nishida H, et al. Nihon Yakurigaku Zasshi 2018; 152: 104-110.
Disclosure
Disclosures: This study was funded by Takeda (China) International Trading Co. Ltd. Yinglian Xiao, Xiuling Li and Yiyang Dai have no conflicts of interest. Kailun Liang and Li Xie are Takeda employees and hold Takeda stock options. Minhu Chen received speaker honoraria from Takeda China, AstraZeneca China, Xian Janssen and Eisai China.
Acknowledgements: Medical writing support for the development of this abstract, under the direction of the authors, was provided by Adityadeb Ghosh, M. Pharm, of Cactus Life Sciences (part of Cactus Communications), funded by Takeda (China) International Trading Co., Ltd., an affiliation of Takeda Pharmaceutical Company, and complied with the Good Publication Practice Guidelines 2022.