Colchicine is safe and effective for secondary prevention of recurrent pericarditis

Abstract

The CORP (COlchicine for Recurrent Pericarditis) trial [7]is a prospective, randomized, double-blind, placebo controlled, multicenter trial to evaluate the efficacy and safety of colchicine (1.0–2.0 mg on the first day, followed by a maintenance dose of 0.5–1.0 mg/day for 6 months) in association with conventional anti-inflammatory therapy for the secondary prevention of recurrence in patients with a first relapse of pericarditis. Patients were excluded if they were having their first episode of acute pericarditis, or their second or subsequent recurrence, or had pericarditis with tuberculous, purulent, or neoplastic causes. The primary study end point was the recurrence rate at 18 months. Secondary end points were symptom persistence after 72 h, remission rate at 1 week, number of recurrences, time to first recurrence, disease-related hospitalizations,cardiac tamponade, and constrictive pericarditis rates.120 patients (60 in the colchicine and 60 in the placebo group) were included in the analysis. The recurrence rate is 24 % in the colchicine group and 55 % in the placebo group (absolute risk reduction 0.31 [95 % CI 0.13–0.46];relative risk reduction 0.56 [0.27–0.73]; number needed to treat 3 [2–7]). Colchicine improves the persistence of symptoms at 72 h (absolute risk reduction 0.30 [95 % IC,0.13–0.45]; relative risk reduction 0.56 [0.27–0.74]). It also reduces the mean number of recurrences, increases the remission rate at 1 week and prolongs the time to subsequent recurrence. Colchicine and placebo groups have similar rates of side effects (7 %) and drug withdrawal (8 vs. 5 %, P = 0.89);no severe side effects occurred in any of the groups. Gastrointestinal intolerance was the main side effect during the study.