Maintenance for healed erosive esophagitis:PhaseⅢcomparison of vonoprazan with lansoprazole

AIM To compare vonoprazan 10 and 20 mg vs lansoprazole 15 mg as maintenance therapy in healed erosive esophagitis(EE).METHODS A 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.RESULTS Rates 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.CONCLUSION Our findings confirm the non-inferiority of vonoprazan 10 and 20 mg to lansoprazole 15 mg as maintenance therapy for patients with healed EE.

Comparison of PPIs and H_2-receptor antagonists plus prokinetics for dysmotility-like dyspepsia

AIM:To compare efficacy of proton pump inhibitors(PPIs)with H2-receptor antagonists(H2RAs)plus prokinetics(Proks)for dysmotility-like symptoms in functional dyspepsia(FD).METHODS:Subjects were randomized to receive openlabel treatment with either rabeprazole 10 mg od(n= 57)or famotidine 10 mg bid plus mosapride 5 mg tid(n=57)for 4 wk.The primary efficacy endpoint was change(%)from baseline in total dysmotility-like dyspepsia symptom score.The secondary efficacy endpoint was patient satisfaction with treatment.RESULTS:The improvement in dysmotility-like dyspep-sia symptom score on day 28 was significantly greater in the rabeprazole group(22.5%±29.2%of baseline) than the famotidine+mosapride group(53.2%± 58.6%of baseline,P<0.0001).The superior benefit of rabeprazole treatment after 28 d was consistent regardless of Helicobacter pylori status.Significantly more subjects in the rabeprazole group were satisfied or very satisfied with treatment on day 28 than in the famotidine+mosapride group(87.7%vs 59.6%,P= 0.0012).Rabeprazole therapy was the only significant predictor of treatment response(P<0.0001),defined as a total symptom score improvement≥50%.CONCLUSION:PPI monotherapy improves dysmotility-like symptoms significantly better than H2RAs plus Proks,and should be the treatment of first choice for Japanese FD.