A Randomized Trial of Colchicine for Acute Pericarditis – Insight from ICAP trial. - Dr. U.Barbero

In the previous years nonrandomized trials supported the use of colchicine for the treatment and prevention of acute pericarditis, however conclusive data were still lacking regarding its use during a first attack of acute pericarditis and for the prevention of recurrent symptoms. In this study, called the Investigation on Colchicine for Acute Pericarditis (ICAP), that is a multicenter, randomized, double-blind trial, eligible adults with acute idiopatic pericarditis and without contraindications 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 (defined as a persistent pericarditis or recurrence after a symptom-free interval of less than 6 weeks ) or recurrent pericarditis (recurrence after a symptom-free interval of at least 6 weeks). A clinical-end-point committee whose members were unaware of study-group assignments adjudicated all events.
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; NNT=4; P<0.001). Regarding to secondary end-points, 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), the hospitalization rate (5.0% vs. 14.2%, P = 0.02) and improved the remission rate at 1 week (85.0% vs. 58.3%, P<0.001). Significantly, adverse effects and rates of study-drug discontinuation were similar in the two study groups and no serious adverse events were observed. Therefore authors concluded that in patients with acute pericarditis, weight adjusted colchicine added to conventional antiinflammatory therapy significantly reduced the rate of recurrences. Imazio et Al, N Engl J Med. 2013 Oct 17;369(16):1522-8

writed  at 19-10-2013 17:25:03