Efficacy of S-pantoprazole 10 mg in the Symptom Control of Non-erosive Reflux Disease:A Phase III Placebo-controlled Trial
- Author:
Yu Kyung CHO
1
;
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
Author Information
- Publication Type:Original Article
- From:Journal of Neurogastroenterology and Motility 2021;27(2):223-230
- CountryRepublic of Korea
- Language:English
-
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.
