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Efficacy and Safety of Colchicine for Treatment of Multiple Recurrences of Pericarditis (CORP-2): A Multicentre, Double-Blind, Placebo-Controlled, Randomised Trial
Study Questions:
Is colchicine effective for the treatment of patients with multiple recurrences of pericarditis?
Methods:
CORP-2 (Colchicine for Recurrent Pericarditis 2) was a multicenter, double-blind trial conducted at four general hospitals in northern Italy. Adult patients with multiple (≥2) recurrences of pericarditis were randomly assigned (1:1) to placebo or colchicine (0.5 mg twice daily for 6 months for patients weighing >70 kg, or 0.5 mg once daily for patients weighing ≤70 kg) in addition to conventional anti-inflammatory treatment with aspirin, ibuprofen, or indomethacin. Permuted block randomization (size four) was done with a central computer-based automated sequence. Patients and all investigators were masked to treatment allocation. The primary outcome was recurrent pericarditis in the intention-to-treat population.
Results:
A total of 240 patients were enrolled and 120 were assigned to each group. The proportion of patients who had recurrent pericarditis was 26 (21.6%) of 120 in the colchicine group and 51 (42.5%) of 120 in the placebo group (relative risk, 0.49; 95% confidence interval, 0.24-0.65; p = 0.0009; number needed to treat = five). Adverse effects and discontinuation of study drug occurred in much the same proportions in each group. The most common adverse events were gastrointestinal intolerance (nine patients in the colchicine group vs. nine in the placebo group) and hepatotoxicity (three vs. one). No serious adverse events were reported.
Conclusions:
Colchicine added to conventional anti-inflammatory treatment significantly reduced the rate of subsequent recurrences of pericarditis in patients with multiple recurrences. Taken together with results from other randomized controlled trials, these findings suggest that, in the absence of contraindications, colchicine probably should be regarded as a first-line treatment for either acute or recurrent pericarditis.
Perspective:
Colchicine is effective for the treatment of acute pericarditis and first recurrences of pericarditis. These data suggest that colchicine also is effective in treating pericarditis among patients with at least two prior recurrences; data are not provided as to how many (other than ≥2) previous episodes of pericarditis patients had prior to enrollment.
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