Tegoprazan demonstrated sustained symptom improvement, disease remission rates, and safety profile similar to lansoprazole over 24 weeks in patients with mild erosive esophagitis that was in remission at baseline, according to study findings published in Alimentary Pharmacology & Therapeutics.
Researchers conducted a multicenter, randomized, double-blind, actively controlled, phase 3 comparator study (ClinicalTrials.gov Identifier: NCT04022096) analyzing the effectiveness of tegoprazan and lansoprazole as maintenance therapies in 351 patients with endoscopically confirmed healing of erosive esophagitis.
Researchers randomly assigned patients with healed erosive esophagitis to receive tegoprazan 25 mg daily (n=174) or lansoprazole 15 mg daily (n=177). After randomization, 57 patients discontinued the study prior to completion.
After 24 weeks of maintenance therapy, patients underwent repeat endoscopies to re-evaluate for disease activity. According to endoscopy, 90.6% of patients in the tegoprazan group and 89.5% of patients in the lansoprazole group remained in disease remission, which was less than a 10% difference between groups (95% CI, -6.2 to 8.3; P =.0014). This confirmed noninferiority of tegoprazan compared with lansoprazole.
Researchers also analyzed maintained disease remission rates between the 2 groups after 12 weeks (tegoprazan: 92.8% vs lansoprazole: 96.0%), which still remained less than a 10% difference between groups (95% CI, -8.8 to 2.3; P =.0082).
Tegoprazan also proved noninferior to lansoprazole in several patient subgroups, including those with the CYP2C19 genotype who are extensive metabolizers and Helicobacter pylori infection. Additionally, neither tegoprazan nor lansoprazole differed significantly in terms of maintenance rate for disease remission based on Los Angeles (LA) grades, which indicated disease severity level.
“Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg in maintenance of healing of mild EE [erosive esophagitis],” the study authors wrote. “Tegoprazan 25 mg could be administered for a long period without risking gastrin elevation or nutritional deficiency.”
Study limitations include an inability to generalize results globally due to inclusion of only Korean patients and the relatively small number of patients with severe erosive esophagitis in the study, which limited the strength of comparisons based on disease severity levels.
Cho YK, Kim JH, Kim HS, et al. Randomised clinical trial: comparison of tegoprazan and lansoprazole as maintenance therapy for healed mild erosive oesophagitis. Aliment Pharmacol Ther. Published online October 31, 2022. doi:10.1111/apt.17255