Summary: Background: Tegoprazan is a novel potassium‐competitive acid blocker for the treatment of acid‐related disorders.Aims: To assess whether tegoprazan is non‐inferior to lansoprazole in terms of efficacy and safety in patients with gastric ulcers.Methods: In this phase 3, double‐blind, active control, multicentre study, 306 gastric ulcer patients were randomised to one of three treatment groups: tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg once daily for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed ulcers confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms and safety were assessed.Results: In the full analysis set, the cumulative healing rates at week 8 were 94.8% (91/96) for the tegoprazan 50 mg, 95.0% (94/99) for the tegoprazan 100 mg and 95.7% (89/93) for the lansoprazole 30 mg groups. At week 4, the respective healing rates were 90.6% (87/96), 91.9% (91/99), and 89.2% (83/93). In per protocol analysis, 4‐week healing rates were 95.4% (84/88), 94.6% (88/93) and 92.9% (79/85) for tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg, respectively. Both doses of tegoprazan were non‐inferior to lansoprazole in ulcer healing at 4 and 8 weeks. The incidence of drug‐related treatment‐emergent adverse events did not differ among groups. The increase in serum gastrin concentration was not higher in tegoprazan‐treated patients than in lansoprazole‐treated patients.Conclusions: Tegoprazan 50 or 100 mg were not inferior to lansoprazole 30 mg once daily in the treatment of gastric ulcers.
14 September 2011 in Journal of Gastroenterology and Hepatology
KRKorean College of Helicobacter Upper Gastrointestinal Research
Korean College of Helicobacter Upper Gastrointestinal Research
+9
Moon Kyung Joo, Chan Hyuk Park, Joon Sung Kim, Jae Myung Park, Ji Yong Ahn, Bong Eun Lee, Jeong Hoon Lee, Hyo-Joon Yang, Yu Kyung Cho, Chang Seok Bang, Beom Jin Kim, Hye-Kyung Jung, Byung-Wook Kim, and Yong Chan Lee, Korean College of Helicobacter and Upper Gastrointestinal Research. Gut and Liver 2020;14:707-26. https://doi.org/10.5009/gnl20246
31 October 2022 in Alimentary Pharmacology & Therapeutics
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.
31 July 2010 in Journal of Neurogastroenterology and Motility
Background: The accuracy of endoscopic ultrasonography (EUS) for preoperative staging of gastric cancer varies. The aim of this study was to investigate the accuracy of EUS tumor (T) and node (N) staging, and to identify the histopathological factors influencing accuracy based on the detailed tumor depth of gastric cancer. Methods: In total, 309 patients with gastric cancer with confirmed pathological staging underwent EUS examination for preoperative staging at Seoul St. Mary’s Hospital, Korea, between January and December 2009. The T and N staging of EUS and the pathologic report were compared. Results: The overall accuracies of EUS for T stage and the detailed T stages were 70.2% and 43.0%, respectively. In detailed stage, tumors greater than 50 mm in diameter were significantly associated with T overstaging (odds ratio (OR) = 2.094). The overall accuracy of EUS for N staging was 71.2%. Tumor size (20 mm ≤ size < 50 mm, OR = 4.389; and 50 mm ≤ size, OR = 8.170), cross-sectional tumor location (circumferential, OR = 4.381) and tumor depth (submucosa, OR = 3.324; muscular propria, OR = 6.923; sub-serosa, OR = 4.517; and serosa-exposed, OR = 6.495) were significant factors affecting incorrect nodal detection. Conclusions: Careful attention is required during EUS examination of large-sized gastric cancers to increase accuracy, especially for T staging.