Randomised phase 3 trial: tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis
- 주제(기타) Gastroenterology & Hepatology; Pharmacology & Pharmacy
- 설명문(일반) [Lee, Kwang Jae] Ajou Univ Hosp, Dept Gastroenterol, Suwon, South Korea; [Son, Byoung Kwan] Eulji Univ, Dept Internal Med, Eulji Hosp, Seoul, South Korea; [Kim, Gwang Ha] Pusan Natl Univ, Dept Internal Med, Sch Med, Busan, South Korea; [Kim, Gwang Ha] Pusan Natl Univ Hosp, Biomd Res Inst, Busan, South Korea; [Jung, Hye-Kyung] Ewha Womans Univ, Coll Med, Dept Internal Med, Seoul, South Korea; [Jung, Hwoon-Yong] Univ Ulsan, Asan Med Ctr, Dept Internal Med, Coll Med, Seoul, South Korea; [Chung, Il-Kwun] Soonchunhyang Univ, Cheonan Hosp, Dept Internal Med, Cheonan, South Korea; [Sung, In-Kyung] Konkuk Univ, Dept Internal Med, Med Ctr, Seoul, South Korea; [Kim, Jin Il] Catholic Univ Korea, Yeouido St Marys Hosp, Coll Med, Dept Internal Med, Seoul, South Korea; [Kim, Jong Hyeok] Hallym Univ, Dept Internal Med, Sacred Heart Hosp, Anyang, South Korea; [Lee, Joon Seong] Soonchunhyang Univ, Dept Internal Med, Seoul Hosp, Seoul, South Korea; [Kwon, Joong Goo] Daegu Catholic Univ, Dept Internal Med, Med Ctr, Daegu, South Korea; [Park, Jung Ho] Kangbuk Samsung Hosp, Dept Internal Med, Seoul, South Korea; [Huh, Kyu Chan] Konyang Univ Hosp, Dept Internal Med, Daejeon, South Korea; [Park, Kyung Sik] Keimyung Univ, Dept Internal Med, Sch Med, Daegu, South Korea; [Park, Moo-In] Kosin Univ, Dept Internal Med, Gospel Hosp, Busan, South Korea; [Kim, Nayoung] Seoul Natl Univ, Dept Internal Med, Bundang Hosp, Seongnam, South Korea; [Lee, Oh Young] Hanyang Univ Hosp, Dept Internal Med, Seoul, South Korea; [Jee, Sam Ryong] Inje Univ, Dept Internal Med, Busan Paik Hosp, Busan, South Korea; [Lee, Sang Kil] Yonsei Univ, Dept Internal Med, Coll Med, Seoul, South Korea; [Youn, Sei Jin] Chungbuk Natl Univ Hosp, Dept Internal Med, Cheongju, South Korea; [Kim, Sung Kook] Kyungpook Natl Univ Hosp, Dept Internal Med, Daegu, South Korea; [Lee, Soo Teik] Chonbuk Natl Univ Hosp, Dept Internal Med, Jeonju, South Korea; [Hong, Su Jin] Soonchunhyang Univ, Digest Dis Ctr & Res Inst, Dept Internal Med, Coll Med, Bucheon, South Korea; [Choi, Suck Chei] Wonkwang Univ Hosp, Dept Internal Med, Iksan, South Korea; [Kim, Tae Nyeun] Yeungnam Univ, Dept Internal Med, Coll Med, Daegu, South Korea; [Youn, Young Hoon] Gangnam Severance Hosp, Dept Internal Med, Seoul, South Korea; [Park, Hyo Ju; Kang, Min Ja; Park, Chi Hye; Kim, Bong Tae; Youn, Sangjun; Song, Geun Seog] CJ Hlthcare Corp, Clin Dev Div, Seoul, South Korea; [Rhee, Poong-Lyul] Sungkyunkwan Univ, Samsung Med Ctr, Dept Med, Seoul, South Korea
- 등재 SCIE, SCOPUS
- OA유형 hybrid, Green Published
- 발행기관 WILEY
- 발행년도 2019
- URI http://www.dcollection.net/handler/ewha/000000159882
- 본문언어 영어
- Published As http://dx.doi.org/10.1111/apt.15185
- PubMed https://pubmed.ncbi.nlm.nih.gov/30843245
초록/요약
Background Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical benefit in acid-related disorders. Aim To confirm the non-inferiority of tegoprazan to esomeprazole in patients with erosive oesophagitis (EE). Methods In this multicentre, randomised, double-blind, parallel-group comparison study, 302 Korean patients with endoscopically confirmed EE (Los Angeles Classification Grades A-D) were randomly allocated to either tegoprazan (50 or 100 mg) or esomeprazole (40 mg) treatment groups for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed EE confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms, safety and tolerability were also assessed. Results The cumulative healing rates at week 8 were 98.9% (91/92), 98.9% (90/91) and 98.9% (87/88) for tegoprazan 50 mg, tegoprazan 100 mg and esomeprazole 40 mg, respectively. Both doses of tegoprazan were non-inferior to esomeprazole 40 mg. The incidence of adverse events was comparable among the groups, and tegoprazan was well-tolerated. Conclusion Once daily administration of tegoprazan 50 or 100 mg showed non-inferior efficacy in healing EE and tolerability to that of esomeprazole 40 mg.
more