Assessment of the efficacy of on-demand tegoprazan therapy in gastroesophageal reflux disease through a randomized controlled trial

Abstract In patients with gastroesophageal reflux disease (GERD) whose symptoms improve with acid-suppression therapy, on-demand treatment could constitute maintenance therapy. This study investigated the comparative efficacy and safety of on-demand tegoprazan and proton-pump inhibitor (PPI) therapy...

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Main Authors: Sun Hyung Kang, Hee Seok Moon, Jae Kyu Sung, Sun Moon Kim, Ki Bae Kim, Seung Woo Lee, Young Sin Cho, Ki Bae Bang, Kyung Ho Song
Format: Article
Language:English
Published: Nature Portfolio 2025-01-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-024-84065-0
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author Sun Hyung Kang
Hee Seok Moon
Jae Kyu Sung
Sun Moon Kim
Ki Bae Kim
Seung Woo Lee
Young Sin Cho
Ki Bae Bang
Kyung Ho Song
author_facet Sun Hyung Kang
Hee Seok Moon
Jae Kyu Sung
Sun Moon Kim
Ki Bae Kim
Seung Woo Lee
Young Sin Cho
Ki Bae Bang
Kyung Ho Song
author_sort Sun Hyung Kang
collection DOAJ
description Abstract In patients with gastroesophageal reflux disease (GERD) whose symptoms improve with acid-suppression therapy, on-demand treatment could constitute maintenance therapy. This study investigated the comparative efficacy and safety of on-demand tegoprazan and proton-pump inhibitor (PPI) therapy in GERD. From six university hospitals in the Daejeon-Chungcheong region, we enrolled patients with GERD who had experienced symptomatic improvement with acid-suppressive therapy and, using a randomization table, randomly allocated these participants to two groups: to receive either tegoprazan 50 mg + esomeprazole placebo or tegoprazan placebo + esomeprazole 20 mg, respectively. The primary endpoint of this study was the intergroup difference in patient satisfaction with on-demand therapy. Among the 69 participants who completed 8 weeks of on-demand therapy and rated patient satisfaction on a 5-point Likert scale, the tegoprazan and esomeprazole groups scored an average of 4.31 and 4.15 points, respectively, without any significant intergroup difference. In the tegoprazan group, 26.2% (182/694) of those with episodes experienced symptom improvement within 30 min, which is a significantly higher proportion compared to 16.1% (104/646) in the esomeprazole group. Compared to the esomeprazole group, the tegoprazan group had a significantly shorter time to symptom improvement overall and a significantly higher proportion of patients who improved within 30 min. No serious treatment-emergent adverse events were reported. Tegoprazan is effective as on-demand therapy for GERD and offers the expectation of faster symptom improvement than with PPIs. Clinical trial KCT0009296, registered at cris.nih.go.kr.
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spelling doaj-art-3d1a12e11605472b9f8dbb00e29d99112025-01-05T12:17:41ZengNature PortfolioScientific Reports2045-23222025-01-011511910.1038/s41598-024-84065-0Assessment of the efficacy of on-demand tegoprazan therapy in gastroesophageal reflux disease through a randomized controlled trialSun Hyung Kang0Hee Seok Moon1Jae Kyu Sung2Sun Moon Kim3Ki Bae Kim4Seung Woo Lee5Young Sin Cho6Ki Bae Bang7Kyung Ho Song8Department of Gastroenterology, Chungnam National University College of MedicineDepartment of Gastroenterology, Chungnam National University College of MedicineDepartment of Gastroenterology, Chungnam National University College of MedicineDepartment of Gastroenterology, College of Medicine, Konyang UniversityDepartment of Gastroenterology, Chungbuk National University College of MedicineDepartment of Gastroenterology, Catholic University of Korea School of MedicineDepartment of Gastroenterology, College of Medicine, Soonchunhyang UniversityDepartment of Gastroenterology, College of Medicine, Dankook UniversityDepartment of Gastroenterology, CHA Ilsan Medical CenterAbstract In patients with gastroesophageal reflux disease (GERD) whose symptoms improve with acid-suppression therapy, on-demand treatment could constitute maintenance therapy. This study investigated the comparative efficacy and safety of on-demand tegoprazan and proton-pump inhibitor (PPI) therapy in GERD. From six university hospitals in the Daejeon-Chungcheong region, we enrolled patients with GERD who had experienced symptomatic improvement with acid-suppressive therapy and, using a randomization table, randomly allocated these participants to two groups: to receive either tegoprazan 50 mg + esomeprazole placebo or tegoprazan placebo + esomeprazole 20 mg, respectively. The primary endpoint of this study was the intergroup difference in patient satisfaction with on-demand therapy. Among the 69 participants who completed 8 weeks of on-demand therapy and rated patient satisfaction on a 5-point Likert scale, the tegoprazan and esomeprazole groups scored an average of 4.31 and 4.15 points, respectively, without any significant intergroup difference. In the tegoprazan group, 26.2% (182/694) of those with episodes experienced symptom improvement within 30 min, which is a significantly higher proportion compared to 16.1% (104/646) in the esomeprazole group. Compared to the esomeprazole group, the tegoprazan group had a significantly shorter time to symptom improvement overall and a significantly higher proportion of patients who improved within 30 min. No serious treatment-emergent adverse events were reported. Tegoprazan is effective as on-demand therapy for GERD and offers the expectation of faster symptom improvement than with PPIs. Clinical trial KCT0009296, registered at cris.nih.go.kr.https://doi.org/10.1038/s41598-024-84065-0TegoprazanPotassium-competitive acid blockersGERDOn-demand
spellingShingle Sun Hyung Kang
Hee Seok Moon
Jae Kyu Sung
Sun Moon Kim
Ki Bae Kim
Seung Woo Lee
Young Sin Cho
Ki Bae Bang
Kyung Ho Song
Assessment of the efficacy of on-demand tegoprazan therapy in gastroesophageal reflux disease through a randomized controlled trial
Scientific Reports
Tegoprazan
Potassium-competitive acid blockers
GERD
On-demand
title Assessment of the efficacy of on-demand tegoprazan therapy in gastroesophageal reflux disease through a randomized controlled trial
title_full Assessment of the efficacy of on-demand tegoprazan therapy in gastroesophageal reflux disease through a randomized controlled trial
title_fullStr Assessment of the efficacy of on-demand tegoprazan therapy in gastroesophageal reflux disease through a randomized controlled trial
title_full_unstemmed Assessment of the efficacy of on-demand tegoprazan therapy in gastroesophageal reflux disease through a randomized controlled trial
title_short Assessment of the efficacy of on-demand tegoprazan therapy in gastroesophageal reflux disease through a randomized controlled trial
title_sort assessment of the efficacy of on demand tegoprazan therapy in gastroesophageal reflux disease through a randomized controlled trial
topic Tegoprazan
Potassium-competitive acid blockers
GERD
On-demand
url https://doi.org/10.1038/s41598-024-84065-0
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