Randomised clinical trial: tegoprazan, a novel potassium‐competitive acid blocker, or lansoprazole in the treatment of gastric ulcer. Issue 5 (23rd July 2020)

• Record Type: Journal Article
• Authors: Cho, Yu Kyung; Choi, Myung‐Gyu; Choi, Suck Chei; Lee, Kee Myung; Kim, Tae Oh; Park, Soo‐Heon; Moon, Jeong Seop; Lim, Yun Jeong; Kang, Dae Hwan; Cheon, Gab Jin; Baik, Gwang Ho; Kim, Kyoung Oh; Cho, Kwang Bum; Jang, Jin Seok; Park, Jong‐Jae; Son, Byoung Kwan; Jung, Hye‐Kyung; Kim, Byung‐Wook; Kim, Sung Kuk; Lee, Soo Teik; Cha, Jae Myung; Kim, Ah Rong; Kim, Eun Ji; Park, Hyun Wook; Song, Geun Seog
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 52:Issue 5(2020)
• Page Start: 789
• Page End: 797
• Publication Date: 2020-07-23
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.15865
• Languages: English
• ISSNs: 0269-2813

Abstract

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.