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Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study

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dc.contributor.authorHa, CW-
dc.contributor.authorPark, YB-
dc.contributor.authorKyung, HS-
dc.contributor.authorHan, CS-
dc.contributor.authorBae, KC-
dc.contributor.authorLim, HC-
dc.contributor.authorPark, SE-
dc.contributor.authorLee, MC-
dc.contributor.authorWon, YY-
dc.contributor.authorLee, DC-
dc.contributor.authorCho, SD-
dc.contributor.authorKim, CW-
dc.contributor.authorKim, JG-
dc.contributor.authorKang, JS-
dc.contributor.authorLee, JH-
dc.contributor.authorChoi, ES-
dc.contributor.authorSeon, JK-
dc.contributor.authorLee, WS-
dc.contributor.authorBin, SI-
dc.date.accessioned2018-05-04T00:24:58Z-
dc.date.available2018-05-04T00:24:58Z-
dc.date.issued2016-
dc.identifier.issn0378-8741-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/14936-
dc.description.abstractETHNOPHARMACOLOGY 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).-
dc.language.isoen-
dc.subject.MESHAged-
dc.subject.MESHAntirheumatic Agents-
dc.subject.MESHCelecoxib-
dc.subject.MESHFemale-
dc.subject.MESHGastrointestinal Diseases-
dc.subject.MESHHumans-
dc.subject.MESHIncidence-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHOsteoarthritis, Knee-
dc.subject.MESHPlant Extracts-
dc.subject.MESHRepublic of Korea-
dc.subject.MESHRisk Assessment-
dc.subject.MESHRisk Factors-
dc.subject.MESHTime Factors-
dc.subject.MESHTreatment Outcome-
dc.titleGastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study-
dc.typeArticle-
dc.identifier.pmid27196293-
dc.contributor.affiliatedAuthor원, 예연-
dc.type.localJournal Papers-
dc.identifier.doi10.1016/j.jep.2016.05.031-
dc.citation.titleJournal of ethnopharmacology-
dc.citation.volume189-
dc.citation.date2016-
dc.citation.startPage310-
dc.citation.endPage318-
dc.identifier.bibliographicCitationJournal of ethnopharmacology, 189. : 310-318, 2016-
dc.embargo.liftdate9999-12-31-
dc.embargo.terms9999-12-31-
dc.identifier.eissn1872-7573-
dc.relation.journalidJ003788741-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Orthopedic Surgery
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