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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
DC Field | Value | Language |
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dc.contributor.author | 박효진 | - |
dc.contributor.author | 이용찬 | - |
dc.date.accessioned | 2021-12-28T17:01:35Z | - |
dc.date.available | 2021-12-28T17:01:35Z | - |
dc.date.issued | 2021-04 | - |
dc.identifier.issn | 2093-0879 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/186898 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | Korean | - |
dc.publisher | Korean Society of Neurogastroenterology and Motility | - |
dc.relation.isPartOf | JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Efficacy of S-pantoprazole 10 mg in the Symptom Control of Non-erosive Reflux Disease: A Phase III Placebo-controlled Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Yu Kyung Cho | - |
dc.contributor.googleauthor | Myung-Gyu Choi | - |
dc.contributor.googleauthor | Hyojin Park | - |
dc.contributor.googleauthor | Ji Won Kim | - |
dc.contributor.googleauthor | Dong Ho Lee | - |
dc.contributor.googleauthor | Kwang Hyun Ko | - |
dc.contributor.googleauthor | Sang Gyun Kim | - |
dc.contributor.googleauthor | Hwoon-Yong Jung | - |
dc.contributor.googleauthor | Su Jin Hong | - |
dc.contributor.googleauthor | Yong Chan Lee | - |
dc.contributor.googleauthor | Si Hyung Lee | - |
dc.identifier.doi | 10.5056/jnm19053 | - |
dc.contributor.localId | A01774 | - |
dc.contributor.localId | A02988 | - |
dc.relation.journalcode | J01623 | - |
dc.identifier.eissn | 2093-0887 | - |
dc.identifier.pmid | 33795542 | - |
dc.subject.keyword | Double-blind method | - |
dc.subject.keyword | Gastroesophageal reflux | - |
dc.subject.keyword | Heartburn | - |
dc.subject.keyword | Pantoprazole | - |
dc.contributor.alternativeName | Park, Hyo Jin | - |
dc.contributor.affiliatedAuthor | 박효진 | - |
dc.contributor.affiliatedAuthor | 이용찬 | - |
dc.citation.volume | 27 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 223 | - |
dc.citation.endPage | 230 | - |
dc.identifier.bibliographicCitation | JOURNAL OF NEUROGASTROENTEROLOGY AND MOTILITY, Vol.27(2) : 223-230, 2021-04 | - |
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