Colchicine Administered in the First Episode of Acute Idiopathic Pericarditis: A Randomized Multicenter Open-label Study

Abstract Introduction and objectives There is a paucity of information about the real benefit of colchicine administration in the first episode of acute idiopathic pericarditis (AIP). The main objective of the present study was to assess the real efficacy of colchicine in patients with AIP who did not receive corticosteroids. Methods Randomized multicenter open-label study. Patients with a first episode of AIP (not secondary to cardiac injury or connective tissue disease) were randomized into 2 groups: group A received conventional anti-inflammatory treatment plus colchicine for 3 months, and group B received conventional anti-inflammatory treatment only. None of the patients received corticosteroids. The primary endpoint was the appearance of recurrent episodes of pericarditis. The secondary endpoint was the time to first recurrence. Follow-up was extended to 24 months. Results A total of 110 patients (83.6% men, age 44 ± 18.3 years) were randomized to group A (n = 59) and group B (n = 51). No differences were found in baseline demographics or in the clinical features of the index episode or in the type of anti-inflammatory treatment administered in both groups. The follow-up was completed by 102 patients (92.7%). No differences were found in the rate of recurrent pericarditis between groups (12 patients [10.9%]; group A vs group B, 13.5% vs 7.8%; P  = .34). The time to first recurrence (group A vs group B, 9.6 ± 9.0 vs 8.3 ± 10.5 months, P  = .80) did not differ between groups. Conclusions Among patients with a first episode of AIP who had not received corticosteroids, the addition of colchicine to conventional anti-inflammatory treatment does not seem to reduce the recurrence rate. Clinical trial registration: URL: https://www.clinicaltrialsregister.eu . Identifier: EudraCT 2009-011258-16