期刊
ARTHRITIS AND RHEUMATISM
卷 62, 期 4, 页码 1060-1068出版社
WILEY
DOI: 10.1002/art.27327
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类别
资金
- URL Pharma
- Altus
- Ardea
- BioCryst
- Novartis
- Pfizer
- Procter Gamble
- Regeneron
- Savient
- EnzymeRx
- Takeda
- UCB
- VA
- Abbott
- Actelion
- Amgen
- Bristol-Myers Squibb
- Biogen Idec
- Centocor
- Gilead
- Genentech
- GlaxoSmithKline
- Merck
- Nitec
- Wyeth
- Xoma
- NIH
- Roche
- United Bio-source
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 >= 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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