title: Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial.
abstract: BACKGROUND
  Colchicine is effective and safe for the treatment and prevention of recurrent pericarditis and might ultimately serve as the initial mode of treatment, especially in idiopathic cases. The aim of this work was to verify the safety and efficacy of colchicine as an adjunct to conventional therapy for the treatment of the first episode of acute pericarditis.
  
  
  RESULTS
  A prospective, randomized, open-label design was used. A total of 120 patients (mean age 56.9+/-18.8 years, 54 males) with a first episode of acute pericarditis (idiopathic, viral, postpericardiotomy syndromes, and connective tissue diseases) were randomly assigned to conventional treatment with aspirin (group I) or conventional treatment plus colchicine 1.0 to 2.0 mg for the first day and then 0.5 to 1.0 mg/d for 3 months (group II). Corticosteroid therapy was restricted to patients with aspirin contraindications or intolerance. The primary end point was recurrence rate. During the 2873 patient-month follow-up, colchicine significantly reduced the recurrence rate (recurrence rates at 18 months were, respectively, 10.7% versus 32.3%; P=0.004; number needed to treat=5) and symptom persistence at 72 hours (respectively, 11.7% versus 36.7%; P=0.003). After multivariate analysis, corticosteroid use (OR 4.30, 95% CI 1.21 to 15.25; P=0.024) was an independent risk factor for recurrences. Colchicine was discontinued in 5 cases (8.3%) because of diarrhea. No serious adverse effects were observed.
  
  
  CONCLUSIONS
  Colchicine plus conventional therapy led to a clinically important and statistically significant benefit over conventional treatment, decreasing the recurrence rate in patients with a first episode of acute pericarditis. Corticosteroid therapy given in the index attack can favor the occurrence of recurrences.
authors.affiliation: Cardiology Department, Maria Vittoria Hospital, University of Turin, Turin, Italy. massimo_imazio@yahoo.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Imazio
authors.forename: Marco
authors.initials: M
authors.lastname: Bobbio
authors.forename: Enrico
authors.initials: E
authors.lastname: Cecchi
authors.forename: Daniela
authors.initials: D
authors.lastname: Demarie
authors.forename: Brunella
authors.initials: B
authors.lastname: Demichelis
authors.forename: Franco
authors.initials: F
authors.lastname: Pomari
authors.forename: Mauro
authors.initials: M
authors.lastname: Moratti
authors.forename: Gianni
authors.initials: G
authors.lastname: Gaschino
authors.forename: Massimo
authors.initials: M
authors.lastname: Giammaria
authors.forename: Aldo
authors.initials: A
authors.lastname: Ghisio
authors.forename: Riccardo
authors.initials: R
authors.lastname: Belli
authors.forename: Rita
authors.initials: R
authors.lastname: Trinchero
mesh_terms: D000208:Acute Disease; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003078:Colchicine / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010493:Pericarditis / Q000188:drug therapy* / Q000503:physiopathology; D012307:Risk Factors; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D001241:Aspirin; D003078:Colchicine