PMID- 35505467
OWN - NLM
STAT- MEDLINE
DCOM- 20220526
LR  - 20220830
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 55
IP  - 12
DP  - 2022 Jun
TI  - The efficacy and safety of keverprazan, a novel potassium-competitive acid 
      blocker, in treating erosive oesophagitis: a phase III, randomised, double-blind 
      multicentre study.
PG  - 1524-1533
LID - 10.1111/apt.16959 [doi]
AB  - BACKGROUND: Keverprazan is a novel potassium-competitive acid blocker (P-CAB) 
      with a strong acid-suppressive capacity that may provide clinical benefit in 
      acid-related diseases. AIMS: This study aimed to explore the non-inferior 
      efficacy and safety of keverprazan to lansoprazole in treating erosive 
      oesophagitis (EO). METHODS: This was a phase III, randomised, double-blind 
      multicentre study. Patients were randomised to receive keverprazan 20 mg once 
      daily or lansoprazole 30 mg once daily for 4-8 weeks. EO healing rates and 
      adverse events (AEs) were compared between the keverprazan group and the 
      lansoprazole group. RESULTS: A total of 238 patients comprised the full analysis 
      set (FAS) while 221 patients comprised the per-protocol set (PPS). For FAS 
      analysis, the EO healing rates at week 8 were 95.8% (114/119) and 89.9% (107/119) 
      for keverprazan and lansoprazole respectively. For PPS analysis, the EO healing 
      rates at week 8 were 99.1% (110/111) and 92.7% (102/110) for keverprazan and 
      lansoprazole respectively. Non-inferiority of keverprazan compared with 
      lansoprazole according to EO healing rates at 8 weeks was demonstrated in both 
      FAS (difference: 5.8% [95% CI: -0.6% to 12.3%]; p = 0.081) and PPS (difference: 
      6.1% [95% CI: 1.1%-11.2%]; p = 0.018) analysis. Drug-related AEs were reported in 
      34.5% (41/119) patients of the keverprazan group and 25.2% (30/119) patients of 
      the lansoprazole group with no significant difference (p = 0.156). No severe AE 
      happened in the keverprazan group. CONCLUSIONS: This study demonstrated the 
      non-inferior efficacy of keverprazan to lansoprazole in treating EO. The 
      incidences of drug-related AEs were comparable between keverprazan and 
      lansoprazole.
CI  - (c) 2022 John Wiley & Sons Ltd.
FAU - Chen, Songfeng
AU  - Chen S
AD  - Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-Sen 
      University, Guangzhou, China.
FAU - Liu, Deliang
AU  - Liu D
AD  - Department of Gastroenterology, The Second Xiangya Hospital of Central South 
      University, Changsha, Hunan Province, China.
FAU - Chen, Honghui
AU  - Chen H
AD  - Department of Gastroenterology, The Second Affiliated Hospital of University of 
      South China, Hengyang, Hunan Province, China.
FAU - Liao, Aijun
AU  - Liao A
AD  - Department of Gastroenterology, The First Affiliated Hospital of University of 
      South China, Hengyang, Hunan Province, China.
FAU - Li, Fangfang
AU  - Li F
AD  - Department of Gastroenterology, Chenzhou First People's Hospital, Chenzhou, Hunan 
      Province, China.
FAU - Liu, Chengxia
AU  - Liu C
AD  - Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou, 
      Shandong Province, China.
FAU - Li, Xing
AU  - Li X
AD  - Department of Gastroenterology, JiangXi PingXiang People's Hospital, Pingxiang, 
      Jiangxi Province, China.
FAU - Li, Shengbao
AU  - Li S
AD  - Department of Gastroenterology, Taihe Hospital, Shiyan, Hubei Province, China.
FAU - Zhang, Yan
AU  - Zhang Y
AD  - Department of Gastroenterology, Zigong Fourth People's Hospital, Zigong, Sichuan 
      Province, China.
FAU - Wang, Yang
AU  - Wang Y
AD  - Department of Gastroenterology, Changzhou First People's Hospital Changzhou, 
      Changzhou, Jiangsu Province, China.
FAU - Xia, Min
AU  - Xia M
AD  - Department of Gastroenterology, Wuxi People's Hospital, Wuxi, Jiangsu Province, 
      China.
FAU - Guo, Qinghong
AU  - Guo Q
AD  - Department of Gastroenterology, The First Hospital of Lanzhou University, 
      Lanzhou, Gansu Province, China.
FAU - Miao, Xinpu
AU  - Miao X
AD  - Department of Gastroenterology, Hainan General Hospital, Haikou, Hainan Province, 
      China.
FAU - Wen, Zhili
AU  - Wen Z
AD  - Department of Gastroenterology, The Second Affiliated Hospital of Nanchang 
      University, Nanchang, Jiangxi Province, China.
FAU - Xu, Min
AU  - Xu M
AD  - Department of Gastroenterology, Affiliated Hospital of Jiangsu University, 
      Jiangsu Province, China.
FAU - Yin, Hekun
AU  - Yin H
AD  - Department of Gastroenterology, Jiangmen Central Hospital, Jiangmen, China.
FAU - Chen, Huixin
AU  - Chen H
AD  - Department of Gastroenterology, Huizhou Central People's Hospital, Huizhou, 
      China.
FAU - Chen, Minhu
AU  - Chen M
AUID- ORCID: 0000-0003-2421-9966
AD  - Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-Sen 
      University, Guangzhou, China.
FAU - Xiao, Yinglian
AU  - Xiao Y
AUID- ORCID: 0000-0002-4223-4943
AD  - Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-Sen 
      University, Guangzhou, China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220503
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (2-Pyridinylmethylsulfinylbenzimidazoles)
RN  - 0 (Anti-Ulcer Agents)
RN  - 0 (Proton Pump Inhibitors)
RN  - 0K5C5T2QPG (Lansoprazole)
RN  - RWP5GA015D (Potassium)
SB  - IM
CIN - Aliment Pharmacol Ther. 2022 Sep;56(6):1071. PMID: 35995736
CIN - Aliment Pharmacol Ther. 2022 Sep;56(6):1072-1073. PMID: 35995746
MH  - 2-Pyridinylmethylsulfinylbenzimidazoles/adverse effects
MH  - *Anti-Ulcer Agents
MH  - Double-Blind Method
MH  - *Esophagitis/drug therapy
MH  - Humans
MH  - Lansoprazole/adverse effects
MH  - *Peptic Ulcer/drug therapy
MH  - Potassium
MH  - Proton Pump Inhibitors/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - erosive oesophagitis
OT  - keverprazan
OT  - lansoprazole
OT  - potassium-competitive acid blocker
EDAT- 2022/05/05 06:00
MHDA- 2022/05/27 06:00
CRDT- 2022/05/04 00:12
PHST- 2022/03/06 00:00 [revised]
PHST- 2022/02/21 00:00 [received]
PHST- 2022/04/21 00:00 [accepted]
PHST- 2022/05/05 06:00 [pubmed]
PHST- 2022/05/27 06:00 [medline]
PHST- 2022/05/04 00:12 [entrez]
AID - 10.1111/apt.16959 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2022 Jun;55(12):1524-1533. doi: 10.1111/apt.16959. Epub 
      2022 May 3.