Introduction
The primary treatment goals of gastroesophageal reflux disease (GERD) include resolving symptoms, preventing complications and symptom relapses, and healing erosive oesophagitis.1, 2 Heartburn and regurgitation are frequent and typical symptoms of GERD. Vonoprazan, a potassium-competitive acid blocker, is approved in China for the treatment of reflux oesophagitis.3, 4 However, there is a paucity of real-world data assessing the relief of typical daily symptoms achieved with 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). This post hoc subgroup analysis conducted in enrolled patients with GERD assessed changes in symptom scores for all-day or night-time heartburn and/or regurgitation during the first 14 days of treatment. A mixed-effects model for repeated measures assessed statistical differences in symptom scores from baseline for each day; least-squares mean (LSM) and its 95% confidence interval are reported (negative values indicate improvement).
Results
Among the 2214 patients included in the effectiveness analysis population of the GERD group, 86.7% were aged <65 years[A.G.1] and 60.8% were male. The LSM change in symptom scores from baseline demonstrated a significant improvement from day 1 of treatment in all-day heartburn and/or regurgitation, daytime heartburn or regurgitation, and night‑time heartburn or regurgitation (Table). Significant improvement continued to be observed on day 14 and throughout all previous days of treatment.
Conclusion
Vonoprazan provided rapid (from day 1), significant and durable symptom relief in patients with GERD.
Table: Improvement in symptom scoresa from baseline to day 14 of vonoprazan treatment (effectiveness analysis population; MMRM analysis)
| Symptom score | Parameter | Day 1 | Day 3 | Day 7 | Day 10 | Day 14 |
| All-day heartburn and regurgitation | LSM change from baseline (SE)/nb | -0.756 (0.0335)c/518 | -0.986 (0.0311)c/516 | -1.207 (0.0279)c/512 | -1.327 (0.0247)c/504 | -1.407 (0.0233)c/493 |
| All-day heartburn | LSM change from baseline (SE)/nb | -0.78 (0.032)c/
679 | -1.02 (0.030)c/
675 | -1.24 (0.026)c/
671 | -1.35 (0.023)c/
661 | -1.41 (0.023)c/
646 |
| All-day regurgitation | LSM change from baseline (SE)/nb | -0.71 (0.031)c/
735 | -0.91 (0.029)c/
732 | -1.11 (0.026)c/
728 | -1.24 (0.023)c/
713 | -1.32 (0.022)c/
693 |
| Night-time heartburn | LSM change from baseline (SE)/nb | -0.8 (0.03)c/
755 | -1.0 (0.03)c/
748 | -1.2 (0.03)c/
744 | -1.3 (0.02)c/
733 | -1.4 (0.02)c/
717 |
| Night-time regurgitation | LSM change from baseline (SE)/nb | -0.7 (0.03)c/
828 | -0.9 (0.03)c/
823 | -1.1 (0.03)c/
816 | -1.2 (0.02)c/
799 | -1.3 (0.02)c/
778 |
LSM, least-squares mean; MMRM, mixed-effects model for repeated measures; SE, standard error.
aNegative values indicate improvement.
bNumber of patients without missing values.
cStatistically significant difference from baseline (all
P<0.001).
References
1. Antunes C, Aleem A and Curtis SA. StatPearls. Treasure Island (FL), 2023.
2. Heidelbaugh JJ, Nostrant TT, Kim C, et al. Am Fam Physician 2003; 68: 1311-1318.
3. Xiao Y, Lu Y, Yang H, et al. Am J Gastroenterol 2023; 118: S345-S345.
4. Oshima T and Miwa H. J Neurogastroenterol Motil 2018; 24: 334-344.
Disclosure
This study was funded by Takeda (China) International Trading Co. Ltd. Yinglian Xiao, Dekui Zhang and Jianyong Chen 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.
