Efficacy and safety of on-demand tegoprazan therapy in gastroesophageal reflux disease: A multicentre, double-blind, randomised, active-controlled pilot study
Abstract
Abstract Background In patients with gastroesophageal reflux disease (GERD) whose symptoms improve with acid-suppression therapy, on-demand treatment could constitute maintenance therapy. Aims This study investigated the comparative efficacy and safety of on-demand tegoprazan and proton-pump inhibitor (PPI) therapy in GERD. Methods 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. Results 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 minutes, 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 69 participants or records.
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