WASHINGTON – Adding colchicine to standard anti-inflammatory treatment for patients with recurrent pericarditis led to significantly fewer subsequent recurrences than did standard treatment alone in a randomized trial with 240 patients.
The findings cement colchicine as a first-line treatment for pericarditis patients who need drug treatment, Dr. Massimo Imazio said at the annual meeting of the American College of Cardiology. "Taken together with results from other randomized controlled trials, these findings suggest that colchicine should probably be regarded as a first-line treatment for either acute or recurrent pericarditis in the absence of contraindications."
Concurrent with Dr. Imazio’s report at the meeting, the results of the study were published online. (Lancet 2014 [doi:10.1016/S0140-6736(13)62709-9]).
Mitchel L. Zoler/Frontline Medical News
Dr. Massimo Imazio
The CORP 2 (Colchicine for Recurrent Pericarditis 2) trial was conducted at four centers in Italy during 2005-2012 and enrolled 240 adults with an episode of pericarditis and a documented prior pericarditis episode that had been followed by a symptom-free interval of at least 6 weeks.
For the study, Dr. Imazio and his associates randomized patients to received colchicine, either at 0.5 mg b.i.d. or once daily in patients weighing 70 kg or less, with no loading dose to avoid potential gastrointestinal adverse effects. Patients also received standard anti-inflammatory treatment with aspirin, ibuprofen, or indomethacin, and select patients could receive corticosteroid treatment. Treatment was continued for 6 months. Patients averaged 49 years of age; more than 80% had idiopathic pericarditis with the rest divided nearly equally between cardiac injury syndrome and connective tissue disease. Enrollment excluded patients with bacterial or neoplastic etiologies for their pericarditis.
Pericarditis occurred in 22% of patients treated with colchicine and 43% of those on placebo during an average follow-up of 20 months, a statistically significant difference for the study’s primary endpoint, reported Dr. Imazio, a cardiologist at Maria Vittoria Hospital in Torino, Italy. This benefit translated into a number needed to treat of five patients to prevent one pericarditis recurrence during 18 months of follow-up, he said. Colchicine was as effective in patients previously treated with the drug as in colchicine-naive patients, and was equally effective in all of the etiologies studied.
The dosage of colchicine used was well tolerated with no excess adverse effects or treatment discontinuations compared with placebo and no serious adverse effects. Overall, colchicine cut recurrence rates by about half based on a meta-analysis of these results along with those from six prior reports from randomized controlled trials of colchicine in a total of 1,275 patients with either a first episode or recurrent pericarditis, Dr. Imazio said. The meta-analysis also showed a consistent safety profile, with no excess adverse events or need for treatment withdrawal. The 6-month duration of treatment was selected arbitrarily; a future study could evaluate the drug for a longer treatment period, he added.
A concern with colchicine is that it morphed a few years ago from a cheap generic drug to a rebranded trade drug, Colcrys, with a large rise in price. Takeda, the company that now solely markets colchicine in the United States, had no role in the CORP 2 study.
Dr. Imazio said that he had no relevant financial disclosures.
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