Randomised clinical trial: tegoprazan, a novel potassium‐competitive acid blocker, or lansoprazole in the treatment of gastric ulcer

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 co...

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Veröffentlicht in:Alimentary pharmacology & therapeutics Jg. 52; H. 5; S. 789 - 797
Hauptverfasser: 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
Format: Journal Article
Sprache:Englisch
Veröffentlicht: England Wiley Subscription Services, Inc 01.09.2020
John Wiley and Sons Inc
Schlagworte:
Adult
Aged
Anti-Ulcer Agents - administration & dosage
Anti-Ulcer Agents - adverse effects
Benzene Derivatives - administration & dosage
Benzene Derivatives - adverse effects
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Endoscopy
Female
Gastrin
Humans
Imidazoles - administration & dosage
Imidazoles - adverse effects
Lansoprazole - administration & dosage
Lansoprazole - adverse effects
Male
Middle Aged
Patients
Potassium
Potassium - metabolism
Proton Pump Inhibitors - administration & dosage
Proton Pump Inhibitors - adverse effects
Randomised Clinical Trial
Republic of Korea
Stomach Ulcer - drug therapy
Treatment Outcome
Ulcers
Wound Healing - drug effects
Republic of Korea
ISSN:0269-2813, 1365-2036, 1365-2036
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Zusammenfassung: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.
Bibliographie:Funding information
The complete list of authors' affiliation are listed in Appendix 1.
The Handling Editor for this article was Dr Colin Howden, and it was accepted for publication after full peer‐review.
This study was funded in full by HK inno.N Corp., Seoul, Korea.
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ISSN:0269-2813
1365-2036
1365-2036
DOI:10.1111/apt.15865