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Published on: July 7, 2016
Colchicine for recurrent pericarditis (CORP): a randomized trial
Massimo Imazio1, Antonio Brucato, Roberto Cemin
1Maria Vittoria Hospital and Ospedale degli Infermi, Torino, Ospedali Riuniti, Bergamo, San Maurizio Regional Hospital, Bolzano, Italy. massimo_imazio@yahoo.it
Background:
Recurrence is the most common complication of pericarditis, affecting 10% to 50% of patients.
Objective:
To evaluate the efficacy and safety of colchicine for the secondary prevention of recurrent pericarditis.
Design:
Prospective, randomized, double-blind, placebo-controlled multicenter trial. (ClinicalTrials.gov registration number: NCT00128414) SETTING: 4 general hospitals in urban areas of Italy.
Patients:
120 patients with a first recurrence of pericarditis.
Intervention:
In addition to conventional treatment, patients were randomly assigned to receive either placebo or colchicine, 1.0 to 2.0 mg on the first day followed by a maintenance dose of 0.5 to 1.0 mg/d, for 6 months.
Measurements:
The primary study end point was the recurrence rate at 18 months. Secondary end points were symptom persistence at 72 hours, remission rate at 1 week, number of recurrences, time to first recurrence, disease-related hospitalization, cardiac tamponade, and rate of constrictive pericarditis.
Results:
At 18 months, the recurrence rate was 24% in the colchicine group and 55% in the placebo group (absolute risk reduction, 0.31 [95% CI, 0.13 to 0.46]; relative risk reduction, 0.56 [CI, 0.27 to 0.73]; number needed to treat, 3 [CI, 2 to 7]). Colchicine reduced the persistence of symptoms at 72 hours (absolute risk reduction, 0.30 [CI, 0.13 to 0.45]; relative risk reduction, 0.56 [CI, 0.27 to 0.74]) and mean number of recurrences, increased the remission rate at 1 week, and prolonged the time to subsequent recurrence. The study groups had similar rates of side effects and drug withdrawal.
Limitation:
Multiple recurrences and neoplastic or bacterial causes were excluded.
Conclusion:
Colchicine is safe and effective for secondary prevention of recurrent pericarditis.
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