| High versus low dosing of oral colchicine for early acute gout flare: Twenty-four-hour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study. | |
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MedLine Citation:
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PMID: 20131255 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Despite widespread use of colchicine, the evidence basis for oral colchicine therapy and dosing in acute gout remains limited. The aim of this trial was to compare low-dose colchicine (abbreviated at 1 hour) and high-dose colchicine (prolonged over 6 hours) with placebo in gout flare, using regimens producing comparable maximum plasma concentrations in healthy volunteers. METHODS: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study compared self-administered low-dose colchicine (1.8 mg total over 1 hour) and high-dose colchicine (4.8 mg total over 6 hours) with placebo. The primary end point was > or = 50% pain reduction at 24 hours without rescue medication. RESULTS: There were 184 patients in the intent-to-treat analysis. Responders included 28 of 74 patients (37.8%) in the low-dose group, 17 of 52 patients (32.7%) in the high-dose group, and 9 of 58 patients (15.5%) in the placebo group (P = 0.005 and P = 0.034, respectively, versus placebo). Rescue medication was taken within the first 24 hours by 23 patients (31.1%) in the low-dose group (P = 0.027 versus placebo), 18 patients (34.6%) in the high-dose group (P = 0.103 versus placebo), and 29 patients (50.0%) in the placebo group. The low-dose group had an adverse event (AE) profile similar to that of the placebo group, with an odds ratio (OR) of 1.5 (95% confidence interval [95% CI] 0.7-3.2). High-dose colchicine was associated with significantly more diarrhea, vomiting, and other AEs compared with low-dose colchicine or placebo. With high-dose colchicine, 40 patients (76.9%) had diarrhea (OR 21.3 [95% CI 7.9-56.9]), 10 (19.2%) had severe diarrhea, and 9 (17.3%) had vomiting. With low-dose colchicine, 23.0% of the patients had diarrhea (OR 1.9 [95% CI 0.8-4.8]), none had severe diarrhea, and none had vomiting. CONCLUSION: Low-dose colchicine yielded both maximum plasma concentration and early gout flare efficacy comparable with that of high-dose colchicine, with a safety profile indistinguishable from that of placebo. |
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Authors:
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Robert A Terkeltaub; Daniel E Furst; Katherine Bennett; Karin A Kook; R S Crockett; Matthew W Davis |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Arthritis and rheumatism Volume: 62 ISSN: 1529-0131 ISO Abbreviation: Arthritis Rheum. Publication Date: 2010 Apr |
Date Detail:
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Created Date: 2010-04-14 Completed Date: 2010-05-04 Revised Date: 2011-12-06 |
Medline Journal Info:
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Nlm Unique ID: 0370605 Medline TA: Arthritis Rheum Country: United States |
Other Details:
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Languages: eng Pagination: 1060-8 Citation Subset: AIM; IM |
Affiliation:
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VAMC San Diego, and University of California, San Diego, CA 92161, USA. rterkeltaub@ucsd.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00506883 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Arthralgia / chemically induced Colchicine / administration & dosage, adverse effects, pharmacokinetics, toxicity* Continental Population Groups Diarrhea / chemically induced Dose-Response Relationship, Drug Female Gout / chemically induced* Humans Male Melena / chemically induced Middle Aged Nausea / chemically induced Pain / chemically induced Placebos Reference Values Vomiting / chemically induced |
| Chemical | |
Reg. No./Substance:
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0/Placebos; 64-86-8/Colchicine |
| Comments/Corrections | |
Comment In:
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Arthritis Rheum. 2011 Nov;63(11):3647-8; author's reply 3648
[PMID:
21792828
]
Arthritis Rheum. 2010 Oct;62(10):3126-7; author reply 3127-8 [PMID: 20617519 ] Evid Based Med. 2010 Dec;15(6):170-1 [PMID: 20713543 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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