Maintenance for healed erosive esophagitis: Phase III comparison of vonoprazan with lansoprazole

Abstract

AIMTo compare vonoprazan 10 and 20 mg vs lansoprazole 15 mg as maintenance therapy in healed erosive esophagitis (EE).METHODSA total of 607 patients aged ≥ 20 years, with endoscopically-confirmed healed EE following 8 wk of treatment with vonoprazan 20 mg once daily, were randomized 1:1:1 to receive lansoprazole 15 mg (n = 201), vonoprazan 10 mg (n = 202), or vonoprazan 20 mg (n = 204), once daily. The primary endpoint of the study was the rate of endoscopically-confirmed EE recurrence during a 24-wk maintenance period. The secondary endpoint was the EE recurrence rate at Week 12 during maintenance treatment. Additional efficacy endpoints included the incidence of heartburn and acid reflux, and the EE healing rate 4 wk after the initiation of maintenance treatment. Safety endpoints comprised adverse events (AEs), vital signs, electrocardiogram findings, clinical laboratory results, serum gastrin and pepsinogen I/II levels, and gastric mucosa histopathology results.RESULTSRates of EE recurrence during the 24-wk maintenance period were 16.8%, 5.1%, and 2.0% with lansoprazole 15 mg, vonoprazan 10 mg, and vonoprazan 20 mg, respectively. Vonoprazan was shown to be non-inferior to lansoprazole 15 mg (P < 0.0001 for both doses). In a post-hoc analysis, EE recurrence at Week 24 was significantly reduced with vonoprazan at both the 10 mg and the 20 mg dose vs lansoprazole 15 mg (5.1% vs 16.8%, P = 0.0002, and 2.0% vs 16.8%, P < 0.0001, respectively); by contrast, the EE recurrence rate did not differ significantly between the two doses of vonoprazan (P = 0.1090). The safety profiles of vonoprazan 10 and 20 mg were similar to that of lansoprazole 15 mg in patients with healed EE. Treatment-related AEs were reported in 11.4%, 10.4%, and 10.3% of patients in the lansoprazole 15 mg, vonoprazan 10 mg, and vonoprazan 20 mg arms, respectively.CONCLUSIONOur findings confirm the non-inferiority of vonoprazan 10 and 20 mg to lansoprazole 15 mg as maintenance therapy for patients with healed EE.

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

“…Erosive esophagitis recurrence rate at 24 weeks was 5.1%. The safety profiles of VPZ 10 and 20 mg were similar to that of LPZ 15 mg in patients with healed erosive esophagitis [45]. The results of this study showed that over a period of 12 months on demand 10 mg VPZ maintained endoscopic remission (86.0%) in patients who had been successfully treated by VPZ 20 mg for RE refractory to PPIs.…”

“…Since the mean percent time of gastric pH 4 or higher by standarddose PPI was approximately 50-65% [29,[42][43][44], the efficacy of VPZ 10 mg could be similar to or higher than that of standard-dose PPI. Ashida et al [45] confirmed the noninferiority of VPZ 10 and 20 mg to LPZ 15 mg as the 24-week maintenance therapy for patients with healed erosive esophagitis. Erosive esophagitis recurrence rate at 24 weeks was 5.1%.…”

Vonoprazan versus proton pump inhibitors for the management of gastroesophageal reflux disease

“…Various clinical studies have reported that vonoprazan is comparable or superior to PPIs for the treatment of GERD including EE and NERD. [ 19 , 20 ] However, it remains unclear whether vonoprazan is superior to PPIs for the treatment of GERD. Therefore, a meta-analysis and systematic review in this field may lead a more accurate conclusion.…”

Role of Acid Suppression in Acid-related Diseases: Proton Pump Inhibitor and Potassium-competitive Acid Blocker

“…Continuous administration of vonoprazan (10 mg/day or 20 mg/day) is more efficacious than that of lansoprazole (15 mg/day) in maintaining healed erosive esophagitis. 44 Therefore, at present, the optimal maintenance strategy for erosive esophagitis is continuous administration of vonoprazan at 10 mg/day (Fig. 1B).…”