Efficacy of Vonoprazan for 48-Week Maintenance Therapy of Patients with Healed Reflux Esophagitis

Abstract

Aims: We aimed to evaluate the efficacy of vonoprazan (VPZ) as maintenance therapy for healed reflux esophagitis (RE). Methods: We enrolled 74 patients diagnosed with RE with frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) total score ≥8 after at least 8 weeks of treatment with standard proton pump inhibitors (PPIs). These patients were switched to VPZ 20 mg for 4 weeks. We also enrolled 71 patients with no endoscopic evidence of erosive esophagitis who received maintenance therapy with VPZ 10 mg for 48 weeks. The primary end point was the proportion of patients who maintained healed RE refractory to PPIs after 48 weeks of maintenance therapy with on demand 10 mg VPZ. Secondary assessment included the proportion of patients with symptomatic nonrelapse at 48 weeks. Results: Fifty patients successfully completed 48-week maintenance therapy. Maintenance therapy with VPZ 10 mg prevented the relapse of esophageal mucosal breaks in 43 (86.0%) of 50 patients at 48 weeks. During the 48-week maintenance therapy, symptomatic nonrelapse rate for acid reflux-related symptom score of FSSG and acid reflux score of Gastrointestinal Symptom Rating Scale at 48 weeks were 70.0 and 72.0%, respectively. No serious adverse events were reported during the study. Conclusion: VPZ 10 mg is clinically effective for maintenance of healed RE for 48 weeks.

The efficacy and safety of keverprazan, a novel potassium‐competitive acid blocker, in treating erosive oesophagitis: a phase III, randomised, double‐blind multicentre study

“…Maintenance therapy with vonoprazan 10 mg once daily prevented the relapse of oesophageal mucosal breaks in 86.0% of EO patients. 33 The efficacy and safety of keverprazan, in the long run, need to be clarified. Lastly, serum gastrin levels were not monitored in this study.…”

Vonoprazan in the management of erosive oesophagitis and peptic ulcer-induced medication: a systematic review

“…At the end of the 24-week 10-mg-vonoprazan maintenance period, the symptomatic non-relapse rates for acid reflux-associated and dysmotility symptom FSSG scores were 86.5 and 80.8%, respectively [6]. During the 48-week 10-mg-vonoprazan maintenance therapy, the symptomatic non-relapse rates for acid reflux-related symptom score of FSSG and acid reflux score of the Gastrointestinal Symptom Rating Scale at 48 weeks were 70.0 and 72.0%, respec- tively [15]. In another study, no significant difference was noted in the FSSG score between 8 and 52 weeks of 10-mg VPZ administration [16].…”

“…In 5 open-label prospective studies, vonoprazan 10 mg once daily showed effective 8-week [11], 24-week [6], 48- week [15], and 52-week [13,16] maintenance therapy of healed reflux oesophagitis or erosive oesophagitis refractory to PPIs [6,11,13,15,16]. On-demand therapy using 20-mg vonoprazan tablets is also an effective alternative maintenance therapy for mild reflux esophagitis [17].…”

Vonoprazan in the management of gastric/peptic ulcers: a systematic review of safety data

“…Considering vonoprazan as maintenance therapy, a total of 4 studies were included in the analysis [22][23][24][25]. Table V shows information about treatment-emergent adverse events, while several adverse events with frequency > 5% reported in the studies are described in Table VI.…”

“…The great variability observed across the studies' estimates is related to whether the treatment was an initial or a maintenance therapy. Regarding serious adverse events, the occurrence ranged from 0.0% to 16.3% and from 0.0% to 2.0% for total and those related to treatment, respectively [16][17][18][19][20][21][22][23][24][25].…”