Evaluation of the Safety and Efficacy of K-CAB (Tegoprazan) as Symptomatic Maintenance Therapy in Patients With NERD: A Multicenter, Randomized Double-Blinded Controlled Trial
Abstract
Objectives: This preliminary, randomized, double-blind, multi-center study evaluated the efficacy of alternate-day tegoprazan (50 mg) versus daily lansoprazole (15 mg) as for maintenance therapy in patients with non-erosive reflux disease (NERD).
Methods: Forty five participants were enrolled and treated for 8 weeks. The primary endpoint was the proportion of symptom-free days. The secondary endpoints were changes in Gastrointestinal Symptom Rating Scale (GSRS) and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores.
Results: It showed no significant difference between groups in the proportion of symptom-free days between both groups (tegoprazan: 60.4%±6.3%; lansoprazole: 74.0%±6.5%). The GSRS and GERD-HRQL score improvements were also comparable between both groups. Both treatments were well tolerated, with no serious adverse events reported.
Conclusions: These findings suggest that alternate-day tegoprazan offers comparable efficacy and safety to daily lansoprazole therapy and may serve as a more flexible and patient-friendly maintenance option for NERD.
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.
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