Comparison of the efficacy of once- and twice-daily colchicine dosage in pediatric patients with familial Mediterranean fever - a randomized controlled noninferiority trial

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dc.contributor.authorPolat, Adem
dc.contributor.authorAçıkel, Cengizhan
dc.contributor.authorSözeri, Betül
dc.contributor.authorDursun, İsmail
dc.contributor.authorKasapçopur, Özgür
dc.contributor.authorGülez, Nesrin
dc.contributor.authorŞimşek, Doğan
dc.date.accessioned2020-03-26T19:23:25Z
dc.date.available2020-03-26T19:23:25Z
dc.date.issued2016
dc.departmentSelçuk Üniversitesien_US
dc.description.abstractBackground: In this study, we examined the efficacy and safety of a once-daily dosage schema of colchicine compared with a twice-daily dosage schema in pediatric patients with familial Mediterranean fever (FMF). Methods: In this 24-week, multicenter, randomized controlled noninferiority trial, pediatric patients newly diagnosed with FMF carrying a homozygous or compound heterozygous mutation and not receiving any treatment were included. Patients were randomly assigned using a block randomization method to receive treatment with a once-or twice-daily dosage. Clinical and laboratory characteristics and medication side effects were recorded and compared between groups. The study was carried out in compliance with Good Clinical Practice and the Consolidated Standards for Reporting of Trials (CONSORT) statement. Results: A total of 92 patients were selected, and 79 patients completed the study. There were 42 patients in the once-daily dosage group and 37 in the twice-daily dosage group. The results indicated that the once-daily dosage was not inferior to the twice-daily dosage regarding decrease in attack frequency and duration as well as improvement in clinical findings and Mor severity scores. Alterations in laboratory findings indicating inflammation, such as erythrocyte sedimentation rate, C-reactive protein, and serum amyloid A, were similar in both groups. The rates of drug side effects were similar between the once-and twice-daily dosage groups, implying comparable safety of colchicine, with the exception of diarrhea, which was slightly higher in the once-daily dosage group. Conclusions: Using colchicine with either a once-or twice-daily dosage provides similar clinical and laboratory improvements. Considering both efficacy and safety, colchicine can be prescribed with a once-daily dosage.en_US
dc.description.sponsorshipScientific Council of the Gulhane Military Medical Academy School of Medicineen_US
dc.description.sponsorshipThis study was funded by the Scientific Council of the Gulhane Military Medical Academy School of Medicine and is registered with ClinicalTrials.gov with the number NCT 1491-1437-11/1539 and the identifier NCT02602028.en_US
dc.identifier.doi10.1186/s13075-016-0980-7en_US
dc.identifier.issn1478-6354en_US
dc.identifier.issn1478-6362en_US
dc.identifier.pmid27055417en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.urihttps://dx.doi.org/10.1186/s13075-016-0980-7
dc.identifier.urihttps://hdl.handle.net/20.500.12395/33384
dc.identifier.volume18en_US
dc.identifier.wosWOS:000374731400001en_US
dc.identifier.wosqualityQ2en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherBMCen_US
dc.relation.ispartofARTHRITIS RESEARCH & THERAPYen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.selcuk20240510_oaigen_US
dc.subjectFamilial Mediterranean feveren_US
dc.subjectPediatricen_US
dc.subjectColchicineen_US
dc.subjectDosage schemaen_US
dc.titleComparison of the efficacy of once- and twice-daily colchicine dosage in pediatric patients with familial Mediterranean fever - a randomized controlled noninferiority trialen_US
dc.typeArticleen_US

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