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Efficacy of S-pantoprazole 10 mg in the Symptom Control of Non-erosive Reflux Disease: A Phase III Placebo-controlled Trial

Authors
 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 
Citation
 JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY, Vol.27(2) : 223-230, 2021-04 
Journal Title
JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY
ISSN
 2093-0879 
Issue Date
2021-04
Keywords
Double-blind method ; Gastroesophageal reflux ; Heartburn ; Pantoprazole
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.
Files in This Item:
T202104800.pdf Download
DOI
10.5056/jnm19053
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Hyo Jin(박효진) ORCID logo https://orcid.org/0000-0003-4814-8330
Lee, Yong Chan(이용찬) ORCID logo https://orcid.org/0000-0001-8800-6906
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/186898
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