Efficacy of s-pantoprazole 10 mg in the symptom control of non-erosive reflux disease: A phase III placebo-controlled trial

Yu Kyung Cho, Myung Gyu Choi, Hyojin Park, Ji Won Kim, Dong Ho Lee, Kwang Hyun Ko, Sang Gyun Kim, Hwoon Yong Jung, Su Jin Hong, Yong Chan Lee, Si Hyung Lee

Research output: Contribution to journalArticlepeer-review

Abstract

Background/Aims S-isomer (S) pantoprazole is more bioavailable and less dependent on cytochrome 2C19 than is racemic pantoprazole. We aim to evaluate the efficacy and safety of 10 mg S-pantoprazole for treatment of non-erosive reflux disease (NERD). Methods In this phase 3, double-blind, randomized placebo controlled, multicenter study, 174 NERD patients were randomized to one of both treatment groups: 10 mg S-pantoprazole, or placebo once daily for 4 weeks. Symptoms and safety were assessed. The efficacy endpoints were complete relief of symptoms, > 50% improvement of all reflux symptoms and recurrence. Results Eighty-eight patients were assigned to the S-pantoprazole group (25 males, mean 43.7 years old) and 86 to the placebo group (32 males, mean 43.0 years old), and 163 patients were subjected to full Analysis Set. A higher proportion of patients in the S-pantoprazole group had complete symptom relief (42.0 % [34/81] vs 17.1% [14/82], P < 0.001) and > 50% symptom responses (66.0% vs 50.0%, P = 0.010 for heartburn; 64.2% vs 28.0%, P = 0.010 for acid regurgitation; and 51.9% vs 30.5%, P = 0.03 for epigastric discomfort) compared to the placebo group. The factors associated with poor responsiveness to PPI were older age, female, greater body mass index, and severe baseline symptoms. Conclusions Low dose of S-pantoprazole (10 mg) for 4 weeks was more efficacious than placebo in providing reflux symptom relief in patients with NERD, especially acid regurgitation. More doses or longer periods of treatment with S-pantoprazole would be needed to completely eliminate symptoms.

Original languageEnglish
Pages (from-to)223-230
Number of pages8
JournalJournal of Neurogastroenterology and Motility
Volume27
Issue number2
DOIs
Publication statusPublished - 2021 Apr 30

Bibliographical note

Publisher Copyright:
© 2021 The Korean Society of Neurogastroenterology and Motility.

All Science Journal Classification (ASJC) codes

  • Clinical Neurology
  • Gastroenterology

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