PMID- 29662293 OWN - NLM STAT- MEDLINE DCOM- 20180918 LR - 20181114 IS - 2219-2840 (Electronic) IS - 1007-9327 (Print) IS - 1007-9327 (Linking) VI - 24 IP - 14 DP - 2018 Apr 14 TI - Maintenance for healed erosive esophagitis: Phase III comparison of vonoprazan with lansoprazole. PG - 1550-1561 LID - 10.3748/wjg.v24.i14.1550 [doi] AB - 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. FAU - Ashida, Kiyoshi AU - Ashida K AD - Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto 607-8062, Japan. rakuwadr1185@rakuwadr.com. FAU - Iwakiri, Katsuhiko AU - Iwakiri K AD - Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo 113-8603, Japan. FAU - Hiramatsu, Naoki AU - Hiramatsu N AD - Department of Gastroenterology and Hepatology, Osaka Rosai Hospital, Sakai, Osaka 591-8025, Japan. FAU - Sakurai, Yuuichi AU - Sakurai Y AD - Takeda Pharmaceutical Company Limited, Osaka 540-8645, Japan. FAU - Hori, Tetsuharu AU - Hori T AD - Takeda Pharmaceutical Company Limited, Osaka 540-8645, Japan. FAU - Kudou, Kentarou AU - Kudou K AD - Takeda Pharmaceutical Company Limited, Osaka 540-8645, Japan. FAU - Nishimura, Akira AU - Nishimura A AD - Takeda Pharmaceutical Company Limited, Osaka 540-8645, Japan. FAU - Umegaki, Eiji AU - Umegaki E AD - Department of Gastroenterology, Kobe University Graduate School of Medicine, Kobe, Hyogo 650-0017, Japan. LA - eng PT - Clinical Trial, Phase III PT - Equivalence Trial PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - World J Gastroenterol JT - World journal of gastroenterology JID - 100883448 RN - 0 (1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine) RN - 0 (Proton Pump Inhibitors) RN - 0 (Pyrroles) RN - 0 (Sulfonamides) RN - 0K5C5T2QPG (Lansoprazole) SB - IM MH - Adult MH - Aged MH - Biopsy MH - Double-Blind Method MH - Esophagitis, Peptic/complications/diagnostic imaging/*drug therapy/pathology MH - Esophagoscopy MH - Esophagus/diagnostic imaging/pathology MH - Female MH - Gastric Mucosa/pathology MH - Gastroesophageal Reflux/drug therapy/epidemiology/etiology MH - Heartburn/drug therapy/epidemiology/etiology MH - Humans MH - Incidence MH - Lansoprazole/*therapeutic use MH - Male MH - Middle Aged MH - Proton Pump Inhibitors/*therapeutic use MH - Pyrroles/*therapeutic use MH - Recurrence MH - Sulfonamides/*therapeutic use MH - Treatment Outcome PMC - PMC5897859 OTO - NOTNLM OT - Erosive esophagitis OT - Gastroesophageal reflux disease OT - Lansoprazole OT - Maintenance therapy OT - Potassium-competitive acid blockers OT - Vonoprazan COIS- Conflict-of-interest statement: Kiyoshi Ashida has received fees and honoraria from Takeda Pharmaceutical Company Limited and Otsuka Pharmaceutical Company Limited; Katsuhiko Iwakiri has received grants, fees, and honoraria from Takeda Pharmaceutical Company Limited, and fees from Otsuka Pharmaceutical Company Limited; Yuuichi Sakurai, Tetsuharu Hori, Kentarou Kudou, and Akira Nishimura are full-time employees of Takeda Pharmaceutical Company Limited; Naoki Hiramatsu and Eiji Umegaki have no conflicts of interest to declare. EDAT- 2018/04/18 06:00 MHDA- 2018/09/19 06:00 PMCR- 2018/04/14 CRDT- 2018/04/18 06:00 PHST- 2017/11/30 00:00 [received] PHST- 2018/02/06 00:00 [revised] PHST- 2018/03/07 00:00 [accepted] PHST- 2018/04/18 06:00 [entrez] PHST- 2018/04/18 06:00 [pubmed] PHST- 2018/09/19 06:00 [medline] PHST- 2018/04/14 00:00 [pmc-release] AID - 10.3748/wjg.v24.i14.1550 [doi] PST - ppublish SO - World J Gastroenterol. 2018 Apr 14;24(14):1550-1561. doi: 10.3748/wjg.v24.i14.1550.