Randomised clinical trial: tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole in the treatment of gastric ulcer
- 주제(기타) Gastroenterology & Hepatology
- 주제(기타) Pharmacology & Pharmacy
- 설명문(일반) [Cho, Yu Kyung; Choi, Myung-Gyu] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Catholic Photomed Res Inst, Seoul, South Korea; [Choi, Suck Chei] Wonkwang Univ Hosp, Iksan, South Korea; [Lee, Kee Myung] Ajou Univ, Ajou Univ Hosp, Sch Med, Suwon, South Korea; [Kim, Tae Oh] Inje Univ, Haeundae Paik Hosp, Sch Med, Busan, South Korea; [Park, Soo-Heon] Catholic Univ Korea, Yeouido St Marys Hosp, Coll Med, Seoul, South Korea; [Moon, Jeong Seop] Inje Univ, Seoul Paik Hosp, Coll Med, Seoul, South Korea; [Lim, Yun Jeong] Dongguk Univ, Coll Med, Ilsan Hosp, Goyang, South Korea; [Kang, Dae Hwan] Pusan Natl Univ, Sch Med, Yangsan Hosp, Yangsan, South Korea; [Cheon, Gab Jin] Ulsan Univ, Gangneung Asan Hosp, Coll Med, Kangnung, South Korea; [Baik, Gwang Ho] Hallym Univ, Coll Med, Chuncheon Sacred Heart Hosp, Chunchon, South Korea; [Kim, Kyoung Oh] Gachon Univ, Sch Med, Gil Med Ctr, Incheon, South Korea; [Cho, Kwang Bum] Keimyung Univ, Sch Med, Daegu, South Korea; [Jang, Jin Seok] Dong A Univ, Coll Med, Busan, South Korea; [Park, Jong-Jae] Korea Univ, Coll Med, Seoul, South Korea; [Son, Byoung Kwan] Eulji Univ Hosp, Seoul, South Korea; [Jung, Hye-Kyung] Ewha Womans Univ, Mokdong Hosp, Seoul, South Korea; [Kim, Byung-Wook] Catholic Univ Korea, Incheon St Marys Hosp, Coll Med, Incheon, South Korea; [Kim, Sung Kuk] Kyungpook Univ, Sch Med, Daegu, South Korea; [Lee, Soo Teik] Chonbuk Natl Univ, Med Sch, Jeonju, South Korea; [Cha, Jae Myung] Kyung Hee Univ, KyungHee Univ Hosp Gangdong, Sch Med, Seoul, South Korea; [Kim, Ah Rong; Kim, Eun Ji; Park, Hyun Wook; Song, Geun Seog] HK Inno N Corp, Clin Dev Div, Seoul, South Korea
- 등재 SCIE, SCOPUS
- OA유형 Green Published, hybrid
- 발행기관 WILEY
- 발행년도 2020
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000172388
- 본문언어 영어
- Published As https://dx.doi.org/10.1111/apt.15865
- PubMed https://pubmed.ncbi.nlm.nih.gov/32701188
초록/요약
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 percentages 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.
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