CORP
Trial question
What is the role of colchicine in patients with a first recurrence of pericarditis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
47.5% female
52.5% male
N = 120
120 patients (57 female, 63 male).
Inclusion criteria: patients with a first recurrence of pericarditis.
Key exclusion criteria: pericarditis with tuberculous, purulent, or neoplastic causes; known severe liver disease; known myopathy; known blood dyscrasias; gastrointestinal disease; or known hypersensitivity to colchicine.
Interventions
N=60 colchicine (1.0-2.0 mg on the first day followed by a maintenance dose of 0.5-1.0 mg/d for 6 months in addition to conventional treatment).
N=60 placebo (matching placebo daily for 6 months in addition to conventional treatment).
Primary outcome
Recurrence at 18 months
24%
55%
55.0 %
41.3 %
27.5 %
13.8 %
0.0 %
Colchicine
Placebo
Significant
decrease ▼
NNT = 3
Significant decrease in recurrence at 18 months (24% vs. 55%; RR 0.44, 95% CI 0.27 to 0.73).
Secondary outcomes
Significant decrease in persistence of symptoms at 72 hours (23% vs. 53%; RR 0.43, 95% CI 0.26 to 0.63).
Significant increase in remission at 1 week (82% vs. 48%; RR 1.71, 95% CI 0.7 to 2.72).
Significantly longer time to recurrence (2.5 vs. 1; MD 1.5, 90% CI 0 to 19.1).
Safety outcomes
No significant differences in side effects (7% vs. 7%, p > 0.99) and drug withdrawal (8% vs. 5%, p=0.89).
Conclusion
In patients with a first recurrence of pericarditis, colchicine was superior to placebo with respect to recurrence at 18 months.
Reference
Imazio M, Brucato A, Cemin R et al. Colchicine for recurrent pericarditis (CORP): a randomized trial. Ann Intern Med. 2011 Oct 4;155(7):409-14.
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