Colchicine for recurrent pericarditis (CORP): a randomized trial

Ann Intern Med. 2011 Oct 4;155(7):409-14. doi: 10.7326/0003-4819-155-7-201110040-00359. Epub 2011 Aug 28.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Colchicine / adverse effects
  • Colchicine / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pericarditis / drug therapy*
  • Pericarditis / prevention & control
  • Prospective Studies
  • Secondary Prevention

Substances

  • Anti-Inflammatory Agents
  • Colchicine

Associated data

  • ClinicalTrials.gov/NCT00128414