A Randomized Trial of Colchicine for Acute Pericarditis

From the Cardiology Department, Maria Vittoria Hospital, Turin (M.I., F.B., D.D., D.F., S.F., R.B., R.T.), the Internal Medicine Department, Ospedale Papa Giovanni XXIII, Bergamo (A.B., S. Maestroni), the Cardiology Department, San Maurizio Regional Hospital, Bolzano (R.C.), the Cardiology Department, Ospedale degli Infermi, Rivoli (S.F.), and the Cardiovascular Department, S. Leopoldo Mandic Hospital, Merate (S. Maggiolini) - all in Italy; the Internal Medicine Department, St. Vincent Hospital, Worcester, MA (D.H.S.); and Chaim Sheba Medical Center, Tel Hashomer and Sacker Faculty of Medicine, Tel Aviv, Israel (Y.A.).
New England Journal of Medicine (Impact Factor: 54.42). 08/2013; DOI: 10.1056/NEJMoa1208536

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 number, NCT00128453 .).

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May 20, 2014