The presence of hiatal hernia is a significant predictor for symptomatic recurrence after cessation of vonoprazan therapy for gastroesophageal reflux disease: a long-term observational study

Abstract

Background

Gastroesophageal reflux disease (GERD) symptoms frequently recur after cessation of acid blockers. The presence of a hiatal hernia may worsen GERD symptoms and increase the risk of esophageal malignancy. The aim of this study is to clarify the timing and predictors for recurrence of GERD symptoms after cessation of vonoprazan (VPZ) therapy.

Methods

A retrospective observational study involved 86 patients who underwent cessation of VPZ therapy for symptomatic GERD. Collated data from medical record review included the endoscopic findings and Izumo scale score.

Results

The mean duration of continuous VPZ therapy before cessation was 7.9 months. GERD symptoms requiring the resumption of VPZ therapy recurred in 66 of 86 patients (77%). Kaplan-Meier analysis showed that overall recurrence-free rates at 6 months, one and two years after VPZ cessation were 44%, 32% and 23%, respectively. Alcohol use, the presence of a hiatal hernia and long-term therapy for more than six months were identified as significant positive predictors for symptomatic recurrence. Notably, hiatal hernia had the highest hazard ratio in both univariate and multivariate analyses. The recurrence-free rate in patients with a hiatal hernia was much lower at 6 months than in patients without a hiatal hernia (15% and 51%, respectively p = 0.002). After the symptomatic recurrence, GERD symptoms improved significantly after one-month VPZ therapy.

Conclusion

The rate of symptomatic recurrence after VPZ cessation in patients with GERD is considerable. Cessation of acid suppression therapy should be cautious in patients with both a hiatal hernia and GERD.

Keywords:

• Gastroesophageal reflux
• vonoprazan
• patient outcome assessment
• prediction
• recurrence

Ethical approval

The study protocol was approved by the Institutional Review Board of the Shinozaki Medical Clinic as described in the Methods section (ID#R5-002), and the need for informed consent was waived by the Institutional Review Board.

Authors’ contributions

S.S., H.O.: conception and design, data collection, data analysis and interpretation, drafting the manuscript, writing the manuscript, final approval of the manuscript. H.Y., Y.M., H.S.: conception and design, revised it critically for important intellectual content, final approval of the manuscript. T.Y., E.J.D: conception and design, writing the manuscript, data analysis and interpretation, revised it critically for important intellectual content, final approval of the manuscript. H.Y.: data analysis and interpretation, revised it critically for important intellectual content, final approval of the manuscript.

Disclosure statement

S.S. has received honoraria from Takeda and Otsuka Pharmaceuticals. H.S, T.Y. and H.Y. have received honoraria from Takeda Pharmaceutical. No potential conflict of interest was reported by the author(s).

Data availability statement

All data generated or analyzed during this study are included in this article. Further enquiries can be directed to the corresponding author.

Additional information

Funding

The authors reported there is no funding associated with the work featured in this article.