J Neurogastroenterol Motil.  2021 Apr;27(2):223-230. 10.5056/jnm19053.

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

Affiliations
  • 1Department of Internal Medicine, The Catholic University of Korea, College of Medicine, Seoul, Korea
  • 2Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 3Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul National University of College of Medicine, Seoul, Korea
  • 4Department of Internal Medicine, Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Gyeonggi-do, Korea
  • 5Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Gyeonggi-do, Korea
  • 6Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
  • 7Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  • 8Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Gyeonggi-do, Korea
  • 9Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 10Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea

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.

Keyword

Double-blind method; Gastroesophageal reflux; Heartburn; Pantoprazole
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