Randomised phase 3 trial: tegoprazan, a novel potassium‐competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis

• DOI: 10.1111/apt.15185
• Publication Date: 2019-03-07T07:38:17Z
• Authors: Kwang Jae Lee; Byoung Kwan Son; Gwang Ha Kim; Hye‐Kyung Jung; Hwoon‐Yong Jung; Il‐Kwun Chung; In‐Kyung Sung; Jin Il Kim; Jong Hyeok Kim; Joon Seong Lee; Joong Goo Kwon; Jung Ho Park; Kyu Chan Huh; Kyung Sik Park; Moo‐In Park; Nayoung Kim; Oh Young Lee; Sam Ryong Jee; Sang Kil Lee; Sei Jin Youn; Sung Kook Kim; Soo Teik Lee; Su Jin Hong; Suck Chei Choi; Tae Nyeun Kim; Young Hoon Youn; Hyo Ju Park; Min Ja Kang; Chi Hye Park; Bong Tae Kim; Sangjun Youn; Geun Seog Song; Poong‐Lyul Rhee
• Keywords: Esomeprazole; Tolerability; Cumulative incidence

Summary Background Tegoprazan is a novel potassium‐competitive acid blocker that has fast onset of action and can control gastric pH for prolonged period, which could offer clinical benefit in acid‐related disorders. Aim To confirm the non‐inferiority tegoprazan to esomeprazole patients with erosive oesophagitis (EE). Methods In this multicentre, randomised, double‐blind, parallel‐group comparison study, 302 Korean endoscopically confirmed EE (Los Angeles Classification Grades A‐D) were randomly allocated either (50 or 100 mg) (40 treatment groups 4 8 weeks. The primary endpoint was cumulative proportion healed by endoscopy up weeks from initiation. Symptoms, safety tolerability also assessed. Results healing rates at week 98.9% (91/92), (90/91) (87/88) 50 mg, mg 40 respectively. Both doses non‐inferior mg. incidence adverse events comparable among groups, well‐tolerated. Conclusion Once daily administration showed efficacy