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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

Journal of Neurogastroenterology and Motility 2021년 27권 2호 p.223 ~ 230
조유경, 최명규, 박효진, 김지원, 이동호, 고광현, 김상균, 정훈용, 홍수진, 이용찬, 이시형,
소속 상세정보
조유경 ( Cho Yu-Kyung ) - Catholic University College of Medicine Department of Internal Medicine
최명규 ( Choi Myung-Gyu ) - Catholic University College of Medicine Department of Internal Medicine
박효진 ( Park Hyo-Jin ) - Yonsei University College of Medicine Gangnam Severance Hospital Department of Internal Medicine
김지원 ( Kim Ji-Won ) - Seoul National University College of Medicine Seoul National University Boramae Medical Center Department of Internal Medicine
이동호 ( Lee Dong-Ho ) - CHA University CHA Bundang Medical Center Department of Internal Medicine
고광현 ( Ko Kwang-Hyun ) - Seoul National University College of Medicine Seoul National University Bundang Hospital Department of Internal Medicine
김상균 ( Kim Sang-Gyun ) - Seoul National University College of Medicine Department of Internal Medicine
정훈용 ( Jung Hwoon-Yong ) - University of Ulsan College of Medicine Asan Medical Center Department of Gastroenterology
홍수진 ( Hong Su-Jin ) - Soonchunhyang University College of Medicine Department of Internal Medicine
이용찬 ( Lee Yong-Chan ) - Yonsei University College of Medicine Severance Hospital Department of Internal Medicine
이시형 ( Lee Si-Hyung ) - Yeungnam University College of Medicine Department of Internal Medicine

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.

키워드

Double-blind method; Gastroesophageal reflux; Heartburn; Pantoprazole

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