Background: A common complication of acute pericarditis is recurrent pericarditis. Approximately 10 to 30 percent of patients with a first episode have a recurrent episode, and the recurrence rate increases to 50 percent after a first recurrence. Colchicine has shown promise for preventing recurrent pericarditis, but recommendations for its use have been based on observational studies. Imazio and colleagues evaluated colchicine as an adjunct to conventional therapy for the secondary prevention of recurrent pericarditis.
The Study: The Colchicine for Recurrent Pericarditis trial is a randomized, double-blind, placebo-controlled study that included 120 patients with a first recurrence of pericarditis. Participants were randomized to receive placebo or 2 mg of colchicine on the first day, followed by 1 mg per day for six months, divided into twice-daily doses. Patients who weighed less than 156 lb (70 kg) or who could not tolerate this dosage received a lower dosage (0.5 mg every 12 hours on the first day, followed by 0.5 mg daily). All participants also received conventional treatment with 800 to 1,000 mg of aspirin or 600 mg of ibuprofen every eight hours for seven to 10 days, with tapering over three to four weeks. Exclusion criteria included renal or hepatic disease, blood dyscrasias, myopathies, or pericarditis from a tuberculous, purulent, or neoplastic source. The primary end point was the recurrence rate of pericarditis at 18 months (12 months after treatment cessation).
Results: Remission rates were significantly higher in the colchicine group at 72 hours and at one week after starting treatment (see accompanying table). The median time to first recurrence also was significantly prolonged in the colchicine group compared with placebo (2.5 versus 1 month, respectively; P < .001). At 18 months, the recurrence rate remained significantly lower in the colchicine group compared with placebo (absolute risk reduction = 0.31; relative risk reduction = 0.56; number needed to treat = 3).
|End point||Placebo group (%)||Colchicine group (%)||P value|
|Persistent symptoms at 72 hours||53||23||.001|
|Persistent symptoms at one week||52||18||< .001|
|Recurrence rate at 18 months||55||24||< .001|
Similar rates of adverse effects and drug withdrawal occurred in both groups, with gastrointestinal intolerance being the main adverse effect (7 percent in the colchicine group versus 5 percent in the placebo group). One case of hepatotoxicity related to concomitant hepatobiliary tract disease was noted in the placebo group.
Conclusion: Colchicine is safe and effective as an adjunct to conventional therapy for recurrent pericarditis, with significant reductions in the recurrence rate, prolonged time to subsequent recurrence, and no severe adverse effects.