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

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 YounSung 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

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 languageEnglish
Pages (from-to)864-872
Number of pages9
JournalAlimentary Pharmacology and Therapeutics
Volume49
Issue number7
DOIs
Publication statusPublished - 2019 Apr

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Esomeprazole
Esophagitis
Potassium
Acids
Los Angeles
Endoscopy
Stomach
Safety
Incidence
Therapeutics

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

Cite this

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. / Randomised phase 3 trial : tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis. In: Alimentary Pharmacology and Therapeutics. 2019 ; Vol. 49, No. 7. pp. 864-872.
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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.",
author = "Lee, {Kwang Jae} and Son, {Byoung Kwan} and Kim, {Gwang Ha} and Jung, {Hye Kyung} and Jung, {Hwoon Yong} and Chung, {Il Kwun} and Sung, {In Kyung} and Kim, {Jin Il} and Kim, {Jong Hyeok} and Lee, {Joon Seong} and Kwon, {Joong Goo} and Park, {Jung Ho} and Huh, {Kyu Chan} and Park, {Kyung Sik} and Park, {Moo In} and Nayoung Kim and Lee, {Oh Young} and Jee, {Sam Ryong} and Lee, {Sang Kil} and Youn, {Sei Jin} and Kim, {Sung Kook} and Lee, {Soo Teik} and Hong, {Su Jin} and Choi, {Suck Chei} and Kim, {Tae Nyeun} and Youn, {Young Hoon} and Park, {Hyo Ju} and Kang, {Min Ja} and Park, {Chi Hye} and Kim, {Bong Tae} and Sangjun Youn and Song, {Geun Seog} and Rhee, {Poong Lyul}",
year = "2019",
month = "4",
doi = "10.1111/apt.15185",
language = "English",
volume = "49",
pages = "864--872",
journal = "Alimentary Pharmacology and Therapeutics",
issn = "0269-2813",
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Lee, KJ, Son, BK, Kim, GH, Jung, HK, Jung, HY, Chung, IK, Sung, IK, Kim, JI, Kim, JH, Lee, JS, Kwon, JG, Park, JH, Huh, KC, Park, KS, Park, MI, Kim, N, Lee, OY, Jee, SR, Lee, SK, Youn, SJ, Kim, SK, Lee, ST, Hong, SJ, Choi, SC, Kim, TN, Youn, YH, Park, HJ, Kang, MJ, Park, CH, Kim, BT, Youn, S, Song, GS & Rhee, PL 2019, 'Randomised phase 3 trial: tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis', Alimentary Pharmacology and Therapeutics, vol. 49, no. 7, pp. 864-872. https://doi.org/10.1111/apt.15185

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 journalArticle

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.

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DO - 10.1111/apt.15185

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