title: A randomized trial of colchicine for acute pericarditis.
abstract: BACKGROUND
  Colchicine is effective for the treatment of recurrent pericarditis. However, conclusive data are lacking regarding the use of colchicine during a first attack of acute pericarditis and in the prevention of recurrent symptoms.
  
  
  METHODS
  In a multicenter, double-blind trial, eligible adults with acute pericarditis were randomly assigned to receive either colchicine (at a dose of 0.5 mg twice daily for 3 months for patients weighing >70 kg or 0.5 mg once daily for patients weighing ≤70 kg) or placebo in addition to conventional antiinflammatory therapy with aspirin or ibuprofen. The primary study outcome was incessant or recurrent pericarditis.
  
  
  RESULTS
  A total of 240 patients were enrolled, and 120 were randomly assigned to each of the two study groups. The primary outcome occurred in 20 patients (16.7%) in the colchicine group and 45 patients (37.5%) in the placebo group (relative risk reduction in the colchicine group, 0.56; 95% confidence interval, 0.30 to 0.72; number needed to treat, 4; P<0.001). Colchicine reduced the rate of symptom persistence at 72 hours (19.2% vs. 40.0%, P=0.001), the number of recurrences per patient (0.21 vs. 0.52, P=0.001), and the hospitalization rate (5.0% vs. 14.2%, P=0.02). Colchicine also improved the remission rate at 1 week (85.0% vs. 58.3%, P<0.001). Overall adverse effects and rates of study-drug discontinuation were similar in the two study groups. No serious adverse events were observed.
  
  
  CONCLUSIONS
  In patients with acute pericarditis, colchicine, when added to conventional antiinflammatory therapy, significantly reduced the rate of incessant or recurrent pericarditis. (Funded by former Azienda Sanitaria Locale 3 of Turin [now Azienda Sanitaria Locale 2] and Acarpia; ICAP ClinicalTrials.gov number, NCT00128453.).
authors.affiliation: Cardiology Department, Maria Vittoria Hospital, Turin, Italy. massimo_imazio@yahoo.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Imazio
authors.forename: Antonio
authors.initials: A
authors.lastname: Brucato
authors.forename: Roberto
authors.initials: R
authors.lastname: Cemin
authors.forename: Stefania
authors.initials: S
authors.lastname: Ferrua
authors.forename: Stefano
authors.initials: S
authors.lastname: Maggiolini
authors.forename: Federico
authors.initials: F
authors.lastname: Beqaraj
authors.forename: Daniela
authors.initials: D
authors.lastname: Demarie
authors.forename: Davide
authors.initials: D
authors.lastname: Forno
authors.forename: Silvia
authors.initials: S
authors.lastname: Ferro
authors.forename: Silvia
authors.initials: S
authors.lastname: Maestroni
authors.forename: Riccardo
authors.initials: R
authors.lastname: Belli
authors.forename: Rita
authors.initials: R
authors.lastname: Trinchero
authors.forename: David H
authors.initials: DH
authors.lastname: Spodick
authors.forename: Yehuda
authors.initials: Y
authors.lastname: Adler
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use; D003078:Colchicine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010493:Pericarditis / Q000188:drug therapy*; D011241:Prednisone / Q000627:therapeutic use; D055502:Secondary Prevention; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D001241:Aspirin; D003078:Colchicine; D011241:Prednisone; D007052:Ibuprofen