SUMMARY: Background: Tegoprazan is a novel potassium‐competitive acid blocker used to treat acid‐related disorders.Aim: To compare tegoprazan 25 mg with lansoprazole 15 mg as maintenance therapy in healed erosive oesophagitis (EE)Methods: In this phase 3, double‐blind, multi‐centre study, patients with endoscopically confirmed healed EE were randomised 1:1 to receive tegoprazan 25 mg or lansoprazole 15 mg once daily for up to 24 weeks. The primary efficacy endpoint was the endoscopic remission rate after 24 weeks. The secondary efficacy endpoint was the endoscopic remission rate after 12 weeks. Safety endpoints included adverse events, clinical laboratory results and serum gastrin and pepsinogen I/II levels.Results: We randomised patients to tegoprazan 25 mg (n = 174) or lansoprazole 15 mg (n = 177). Most had mild EE (Los Angeles (LA) grade A: 57.3%, LA grade B: 37.3%). The endoscopic remission rate after 24 weeks was 90.6% with tegoprazan and 89.5% with lansoprazole. Tegoprazan was not inferior to lansoprazole for maintaining endoscopic remission at 24 weeks and 12 weeks. In subgroup analysis, tegoprazan 25 mg showed no significant difference in maintenance rate according to LA grade (p = 0.47). The maintenance effect of tegoprazan was consistent in CYP2C19 extensive metabolisers (p = 0.76). Increases in serum gastrin were not higher in tegoprazan‐treated than lansoprazole‐treated patients.Conclusions: Tegoprazan 25 mg was non‐inferior to lansoprazole 15 mg in maintenance of healing of mild EE. In this study, tegoprazan had a similar safety profile to lansoprazole.
8 December 2011 in British Journal of Clinical Pharmacology
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Triple therapy using a proton pump inhibitor with two antibiotics is the standard treatment for H. pylori infection. However, the increasing prevalence of antibiotic resistance has eroded the high success rates initially reported for the standard triple therapy.WHAT THIS STUDY ADDS• Compared with standard triple therapy, amoxicillin/lansoprazole dual therapy, given three times daily for H. pylori had a similar eradication rate with fewer side effects.AIM: We compared three times daily dual therapy with standard triple therapy for effectiveness and safety in H. pylori infection.METHODS: Two hundred and four H. pylori positive patients with peptic ulcer were randomly assigned to one of two regimens: (i) triple therapy with amoxicillin, clarithromycin and lansoprazole twice daily for 2 weeks or (ii) dual therapy with amoxicillin and lansoprazole three times daily for 2 weeks. The success of eradication was evaluated 4 to 5 weeks after completing treatment.RESULTS: The eradication rate was 82.8% in the triple therapy group and 78.4% in the dual therapy group by per protocol analysis. This difference was not significant (P= 0.573). Adverse events were more frequent in the triple therapy group than in the dual therapy group (P= 0.002).CONCLUSIONS: Because dual therapy had fewer side effects than triple therapy and a similar eradication rate, dual therapy may provide an acceptable alternative first line therapy for H. pylori eradication in Korea.
Gwang Ha Kim, Hang Lak Lee, Moon Kyung Joo, Hong Jun Park, Sung Woo Jung, Ok-Jae Lee, Hyungkil Kim, Hoon Jai Chun, Soo Teik Lee, Ji Won Kim, Han Ho Jeon, Il-Kwun Chung, Hyun-Soo Kim, Dong Ho Lee, Kyoung-Oh Kim, Yun Jeong Lim, Seun-Ja Park, Soo-Jeong Cho, Byung-Wook Kim, Kwang Hyun Ko, Seong Woo Jeon, Jae Gyu Kim, In-Kyung Sung, Tae Nyeun Kim, Jae Kyu Sung, and Jong-Jae Park. Gut and Liver 2021;15:841-50. https://doi.org/10.5009/gnl20338