Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study
DC Field | Value | Language |
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dc.contributor.author | Ha, Chul-Won | - |
dc.contributor.author | Park, Yong-Beom | - |
dc.contributor.author | Kyung, Hee-Soo | - |
dc.contributor.author | Han, Chung-Soo | - |
dc.contributor.author | BaeE, Ki-Cheor | - |
dc.contributor.author | Lim, Hong-Chul | - |
dc.contributor.author | Park, Sang-Eun | - |
dc.contributor.author | Lee, Myung Chul | - |
dc.contributor.author | Won, Ye-Yeon | - |
dc.contributor.author | Lee, Dong-Chul | - |
dc.contributor.author | Cho, Sung-Do | - |
dc.contributor.author | Kim, Chang-Wan | - |
dc.contributor.author | Kim, Jin-Goo | - |
dc.contributor.author | Kang, Joon-Soon | - |
dc.contributor.author | Lee, Ju-Hong | - |
dc.contributor.author | Choi, Eui-Sung | - |
dc.contributor.author | Seon, Jong-Keun | - |
dc.contributor.author | Lee, Woo-Suk | - |
dc.contributor.author | Bin, Seong-Il | - |
dc.date.available | 2019-03-08T12:38:36Z | - |
dc.date.issued | 2016-08 | - |
dc.identifier.issn | 0378-8741 | - |
dc.identifier.issn | 1872-7573 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/6648 | - |
dc.description.abstract | Ethnopharmacology relevance: A previous study indicated non-inferiority of GCSB-5 to celecoxib regarding efficacy and safety in treating OA; however, the gastrointestinal (GI) safety data was limited to 12 weeks. Accordingly, a longer term study with a larger number of patients was necessary to establish the GI safety of GCSB-5. Aim of study: The primary goal was to determine the safety and efficacy of 24-week use of GCSB-5. The secondary goal was to compare the GI safety data of GCSB-5 with that of the previously reported Celecoxib Long-term Arthritis Safety Study (CLASS). Method: This was a 24-week, multicenter, single-arm phase IV Study for the safety and efficacy of GCSB-5. A total of 761 patients were enrolled and 756 patients received at least one dose of GCSB-5. Among them, 629 patients (82.7%) completed the 24 week follow up. The primary goal was to determine the safety and efficacy of GCSB-5 for 24 weeks. The secondary goal was to compare the GI safety data of GCSB-5 with that of the previously reported Celecoxib Long-term Arthritis Safety Study (CLASS). Results: The incidence of GI disorders of GCSB-5 was 23.7%. The annual rate of perforation, ulcer obstruction, or bleeding (PUB) incidence was 0.0%. The drop-out rate due to GI disorders following GCSB-5 use was 4.8%. Compared to celecoxib data from CLASS, the incidence of GI disorders (23.7% vs. 31.4%, p < 0.001), annual rate of PUB and gastroduodenal ulcers (0.0% vs 2.2%, p = 0.004), and drop-out rate due to GI disorders following GCSB-5 use were significantly low (4.8% vs 8.7%, p < 0.001). Efficacy was proven by significant improvements in Western Ontario McMaster Questionnaire (WOMAC) scale, Korean Knee Score (KKS), 100-mm pain visual analogue scale (VAS), and physician's global assessments of patient's response to therapy (PGART). Conclusions: The safety and efficacy profile of GCSB-5 are comparable to celecoxib. These results indicate GCSB-5 is safe for a long-term treatment of knee OA patients. Trial registration: ClinicalTrials.gov (NCT01604239). (C) 2016 The Authors. Published by Elsevier Ireland Ltd. All rights reserved. | - |
dc.format.extent | 9 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | ELSEVIER IRELAND LTD | - |
dc.title | Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.jep.2016.05.031 | - |
dc.identifier.bibliographicCitation | JOURNAL OF ETHNOPHARMACOLOGY, v.189, pp 310 - 318 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.wosid | 000382273800031 | - |
dc.identifier.scopusid | 2-s2.0-84976480682 | - |
dc.citation.endPage | 318 | - |
dc.citation.startPage | 310 | - |
dc.citation.title | JOURNAL OF ETHNOPHARMACOLOGY | - |
dc.citation.volume | 189 | - |
dc.type.docType | Article | - |
dc.publisher.location | 아일랜드 | - |
dc.subject.keywordAuthor | GCSB-5 | - |
dc.subject.keywordAuthor | Shinbaro | - |
dc.subject.keywordAuthor | Osteoarthritis | - |
dc.subject.keywordAuthor | GI safety | - |
dc.subject.keywordAuthor | Herbal medicine | - |
dc.subject.keywordPlus | NONSTEROIDAL ANTIINFLAMMATORY DRUGS | - |
dc.subject.keywordPlus | SYMPTOMATIC KNEE OSTEOARTHRITIS | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | RHEUMATOID-ARTHRITIS | - |
dc.subject.keywordPlus | CONTROLLED-TRIAL | - |
dc.subject.keywordPlus | WESTERN ONTARIO | - |
dc.subject.keywordPlus | PHASE-III | - |
dc.subject.keywordPlus | CELECOXIB | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | RISK | - |
dc.relation.journalResearchArea | Plant Sciences | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalResearchArea | Integrative & Complementary Medicine | - |
dc.relation.journalWebOfScienceCategory | Plant Sciences | - |
dc.relation.journalWebOfScienceCategory | Chemistry, Medicinal | - |
dc.relation.journalWebOfScienceCategory | Integrative & Complementary Medicine | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.description.journalRegisteredClass | sci | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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