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. 2022 Jul 28;28(28):3608–3619. doi: 10.3748/wjg.v28.i28.3608

Table 2.

Clinical studies regarding the efficacy of potassium-competitive acid blocker in gastroesophageal reflux disease treatment

Ref.
Country/region
Study design
Patients, n
Diagnosis
Treatment groups
Duration of treatment, wk
Clinical outcomes
Ashida et al[42] Japan Multicenter, randomized, double-blind 732 EE LPZ 30 mg; VPZ 5 mg; VPZ 10 mg; VPZ 20 mg; VPZ 40 mg 8 All VPZ regimens were non-inferior to LPZ 30 mg treatment. The proportions of healed EE subjects were 87.3%, 86.4%, 100%, 96.0%, and 87.0% with VPZ 5, 10, 20, 40 mg, and LPZ 30 mg, respectively
Ashida et al[43] Japan Multicenter, randomized, double-blind 607 EE LPZ 15 mg; VPZ 10 mg; VPZ 20 mg 24 The EE recurrence rates were 16.8%, 5.1%, and 2.0% with LPZ 15 mg, VPZ 10 mg, and VPZ 20 mg, respectively, over the 24-wk maintenance period
Shinozaki et al[47] Japan Retrospective cohort 55 NERD = 30; EE = 25 VPZ 10 mg 4 The VPZ 10 mg for 1-mo alleviated GERD symptoms in 89% and were sustained in 82% after 1 yr without further therapy
Oshima et al[48] Japan Randomized placebo control 32 EE LPZ 30 mg; VPZ 20 mg 2 The heartburn was relieved earlier with VPZ than with LPZ, and it was completely relieved in 31.3% and 12.5% of patients on day 1 with VPZ and LPZ, respectively
Akiyama et al[49] Japan Retrospective cohort with prospective study 13 PPI-refractory GERD PPIs switch to VPZ 20 mg 8 The median gastric acid exposure times of the VPZ 20 mg were lower than the median gastric acid exposure times of the PPI treatment in both daytime and nocturnal observations. The VPZ 20 mg outperforms PPIs in stomach acid suppression, EAE control, symptom alleviation, and esophagitis healing in patients with PPI-refractory GERD
Mizuno et al[50] Japan Open-label, single-center, prospective study 50 PPI-refractory RE PPIs switch to VPZ 20 mg for 4 wk and VPZ 10 mg 48 VPZ 10 mg prevented the recurrence of esophageal mucosal breaks in 43 of 50 (86.0%) patients. VPZ 10 mg is clinically efficacious for the long-term maintenance of healed RE
Xiao et al[51] China, South Korea, Taiwan, Malaysia Phase III, double-blind, multicenter study 481 EE LPZ 30 mg; VPZ 20 mg 8 The 8-wk EE healing rates in the VPZ and LPZ groups were 92.4% and 91.3%, respectively. VPZ 20 mg was not inferior to LPZ 30 mg in EE healing at 8 wk
Okanobu et al[52] Japan Randomized control study 73 EE VPZ 10 mg; VPZ 20 mg Each dose for 4 wk and VPZ 10 mg for 8 wk VPZ 10 mg had the same result as VPZ 20 mg in mucosal healing and symptom reduction at 4 wk and throughout the trial
Matsuda et al[53] Japan Multicenter, randomized, cross-over study 122 Erosive GERD VPZ 10 mg; LPZ 15 mg Every 2nd day for 4 wk and cross-over for more 4 wk GERD symptoms were significantly reduced with VPZ 10 mg every other day, as measured by the FSSG and the gastrointestinal symptom rating scale
Lee et al[54] South Korea Randomized, double-blind, parallel-group comparison study 302 EE TPZ 50 mg; TPZ 100 mg; EPZ 40 mg 4 and 8 At week 8, the cumulative healing rates for TPZ 50 mg, TPZ 100 mg, and EPZ 40 mg were 98.9%, 98.9%, and 98.9%, respectively
Kim et al[55] South Korea Phase III, double-blind, placebo-controlled, multicenter study 324 NERD TPZ 50 mg; TPZ 100 mg; placebo 4 The proportions of heartburn-free days and full-resolution rates of heartburn were significantly higher in both TPZ groups than in the placebo group
Lee et al[56] South Korea Phase III, multicenter, randomized, double-blind trial 260 EE FPZ 40 mg; EPZ 40 mg 8 FPZ 40 mg was non-inferior to EPZ 40 mg. FPZ 40 mg provided better symptom relief in patients with moderate to severe heartburn, with the effect lasting throughout the night

EAE: Esophageal acid exposure; EE: Erosive esophagitis; EPZ: Esomeprazole; FPZ: Fexuprazan; FSSG: Frequency scale for the symptoms of gastroesophageal reflux disease; GERD: Gastroesophageal reflux disease; LPZ: Lansoprazole; NERD: Non-erosive reflux disease; PPI: Proton pump inhibitor; RE: Reflux esophagitis; TPZ: Tegoprazan; VPZ: Vonoprazan.