ICAP
Trial question
What is the effect of colchicine in patients with acute pericarditis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 240
240 patients (95 female, 145 male).
Inclusion criteria: adult patients with acute pericarditis who were receiving conventional treatment.
Key exclusion criteria: tuberculous, neoplastic, or purulent pericarditis; severe liver disease, skeletal myopathy; blood dyscrasia; IBD; hypersensitivity to colchicine or other contraindication to its use; current treatment with colchicine; and life expectancy < 18 months; pregnant or lactating women.
Interventions
N=120 colchicine (at a dose of 0.5 mg BID for 3 months for patients weighing > 70 kg or 0.5 mg once daily for patients weighting ≤ 70 kg).
N=120 placebo (identical placebo for 3 months).
Primary outcome
Incessant or recurrent pericarditis
16.7%
37.5%
37.5 %
28.1 %
18.8 %
9.4 %
0.0 %
Colchicine
Placebo
Significant
decrease ▼
NNT = 4
Significant decrease in incessant or recurrent pericarditis (16.7% vs. 37.5%; RR 0.44, 95% CI 0.28 to 0.7).
Secondary outcomes
Significant decrease in symptom persistence at 72 hours (19.2% vs. 40%; RR 0.48, 95% CI 0.2 to 0.76).
Significant decrease in hospitalization (5% vs. 14.2%; RR 0.35, 95% CI 0.05 to 0.65).
Significant increase in remission at 1 week (85% vs. 58.3%; RR 1.46, 95% CI 0.59 to 2.33).
Safety outcomes
No significant difference in overall adverse effects and rates of study-drug discontinuation.
Conclusion
In adult patients with acute pericarditis who were receiving conventional treatment, colchicine was superior to placebo with respect to incessant or recurrent pericarditis.
Reference
Imazio M, Brucato A, Cemin R et al. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013 Oct 17;369(16):1522-8.
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