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A Randomized Trial of Colchicine for Acute Pericarditis
Study Questions:
Is colchicine therapy during the initial episode useful for prevention of recurrence of acute pericarditis?
Methods:
In ICAP (Investigation on Colchicine for Acute Pericarditis), a multicenter, double-blind trial, adult patients with an initial episode of acute pericarditis (idiopathic, viral, after cardiac injury, or associated with connective tissue disease) at one of five hospitals in Italy were randomly assigned to receive either colchicine (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 anti-inflammatory therapy with aspirin or ibuprofen. Follow-up was ≥18 months per patient. 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, 0.30-0.72; 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:
The authors concluded that in patients with acute pericarditis, colchicine, when added to conventional anti-inflammatory therapy, significantly reduced the rate of incessant or recurrent pericarditis.
Perspective:
Colchicine is known to be effective for the treatment of recurrent pericarditis. This prospective, multicenter study suggests that it also is effective in reducing the rate of recurrence when administered at the time of an initial episode. If there is a positive aspect to an increase in price from ~$0.09 to ~$4.85 per tablet that accompanied the Food and Drug Administration approval of colchicine (http://en.wikipedia.org/wiki/Colchicine; accessed 9/1/2013), it might be prospective trials documenting efficacy and new indications. It is not yet known whether the use of colchicine in all patients with acute pericarditis is either cost-effective or medically necessary, or whether it still should be reserved for use only in the event of disease recurrence.
Keywords: Colchicine, Pericarditis, Italy
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