Efficacy of Step-Down Therapy Using Vonoprazan for Symptomatic Mild Reflux Esophagitis.

Abstract

Objective: Patient-reported outcomes (PROs) are becoming pivotal in managing gastroesophageal reflux disease (GERD). Current Japanese guidelines for GERD recommend vonoprazan (VPZ) as a treatment option for mild reflux esophagitis (RE). However, it has been hypothesized that 4 weeks of VPZ 20 mg is not always necessary for mild RE if the treatment outcome is based on patient symptoms. This study is aimed at elucidating the efficacy of a new tapering therapeutic strategy (step-down therapy) using VPZ for symptomatic mild RE based on PRO. Methods: This multicenter retrospective study examined VPZ's efficacy for step-down therapy between October 2021 and November 2022. Included were 63 consecutive patients from the outpatient clinics of Toranomon Hospital and Toranomon Hospital Kajigaya with symptoms associated with RE (frequency scale for the symptoms of GERD (FSSG) scores ≥ 8 points) and mild RE classified as the Los Angeles Classification Grade A or B. Step-down therapy was defined as a treatment period of 28 days. VPZ 20 mg was administered as the initial treatment. Afterward, patients were allowed to step down to VPZ 10 mg if their symptoms improved, and VPZ could be discontinued if symptoms disappeared. If symptoms worsened, the dosage could be increased from 10 to 20 mg VPZ, or VPZ could be restarted at 20 mg after discontinuation. Results: The proportion of patients whose FSSG scores decreased by ≥ 3 points with step-down therapy was 76.2% (48/63 patients). The median FSSG scores before and after step-down therapy were 13 (range, 8-35) and 7 (range, 0-29), respectively (p < 0.01). Overall, 71.4% (45/63) of the patients stepped down from 20 to 10 mg VPZ, and 46% (29/63) of the patients discontinued VPZ. Conclusion: Step-down therapy using VPZ may be a viable treatment option for symptomatic patients with mild RE.