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.

Colchicine for recurrent pericarditis (CORP): A randomized trial / M. Imazio, A. Brucato, R. Cemin, S. Ferrua, R. Belli, S. Maestroni, R. Trinchero, D.H. Spodick, Y. Adler. - In: ANNALS OF INTERNAL MEDICINE. - ISSN 0003-4819. - 155:7(2011), pp. 409-414. [10.7326/0003-4819-155-7-201110040-00359]

Colchicine for recurrent pericarditis (CORP): A randomized trial

A. Brucato;
2011

Abstract

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.
Conventional therapy; clinical benefits; management; diseases; prevention; rationale; diagnosis; outcomes; adjunct; design
Settore MED/09 - Medicina Interna
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/635125
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