Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 864-872 |
| Number of pages | 9 |
| Journal | Alimentary Pharmacology and Therapeutics |
| Volume | 49 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - 2019 Apr |
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All Science Journal Classification (ASJC) codes
- Hepatology
- Gastroenterology
- Pharmacology (medical)
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Randomised phase 3 trial : tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis. / Lee, Kwang Jae; Son, Byoung Kwan; Kim, Gwang Ha; Jung, Hye Kyung; Jung, Hwoon Yong; Chung, Il Kwun; Sung, In Kyung; Kim, Jin Il; Kim, Jong Hyeok; Lee, Joon Seong; Kwon, Joong Goo; Park, Jung Ho; Huh, Kyu Chan; Park, Kyung Sik; Park, Moo In; Kim, Nayoung; Lee, Oh Young; Jee, Sam Ryong; Lee, Sang Kil; Youn, Sei Jin; Kim, Sung Kook; Lee, Soo Teik; Hong, Su Jin; Choi, Suck Chei; Kim, Tae Nyeun; Youn, Young Hoon; Park, Hyo Ju; Kang, Min Ja; Park, Chi Hye; Kim, Bong Tae; Youn, Sangjun; Song, Geun Seog; Rhee, Poong Lyul.
In: Alimentary Pharmacology and Therapeutics, Vol. 49, No. 7, 04.2019, p. 864-872.Research output: Contribution to journal › Article
TY - JOUR
T1 - Randomised phase 3 trial
T2 - tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis
AU - Lee, Kwang Jae
AU - Son, Byoung Kwan
AU - Kim, Gwang Ha
AU - Jung, Hye Kyung
AU - Jung, Hwoon Yong
AU - Chung, Il Kwun
AU - Sung, In Kyung
AU - Kim, Jin Il
AU - Kim, Jong Hyeok
AU - Lee, Joon Seong
AU - Kwon, Joong Goo
AU - Park, Jung Ho
AU - Huh, Kyu Chan
AU - Park, Kyung Sik
AU - Park, Moo In
AU - Kim, Nayoung
AU - Lee, Oh Young
AU - Jee, Sam Ryong
AU - Lee, Sang Kil
AU - Youn, Sei Jin
AU - Kim, Sung Kook
AU - Lee, Soo Teik
AU - Hong, Su Jin
AU - Choi, Suck Chei
AU - Kim, Tae Nyeun
AU - Youn, Young Hoon
AU - Park, Hyo Ju
AU - Kang, Min Ja
AU - Park, Chi Hye
AU - Kim, Bong Tae
AU - Youn, Sangjun
AU - Song, Geun Seog
AU - Rhee, Poong Lyul
PY - 2019/4
Y1 - 2019/4
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85062770750&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85062770750&partnerID=8YFLogxK
U2 - 10.1111/apt.15185
DO - 10.1111/apt.15185
M3 - Article
C2 - 30843245
AN - SCOPUS:85062770750
VL - 49
SP - 864
EP - 872
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
SN - 0269-2813
IS - 7
ER -