Richard G. Bach, MD
In patients with a first recurrence of pericarditis, what are the efficacy and safety of adding colchicine to conventional treatment to prevent further recurrence?
Randomized placebo-controlled trial (COlchine for Recurrent Pericarditis [CORP]). ClinicalTrials.gov NCT00128414.
Blinded (patients, clinicians, outcome assessors, and monitoring committee).*
Mean 23 months.
4 general hospitals in Italy.
120 adults ≥ 18 years of age (mean age 48 y, 53% men) with a first recurrence of pericarditis and a favorable short-term prognosis. Exclusion criteria included pericarditis of tuberculous, purulent, or neoplastic cause; severe liver disease; aminotransferase levels > 1.5 × the upper limit of normal; serum creatinine level > 221 µmol/L (2.5 mg/dL); blood dyscrasias; gastrointestinal disease; current or previous use of colchicine; and pregnancy or lactation or childbearing potential without sufficient contraception.
Colchicine (n = 60) or placebo (n = 60) added to conventional treatment with aspirin or ibuprofen. Colchicine was administered at a dose of 1 to 2 mg on day 1 followed by 0.5 to 1 mg/d, in 2 doses 12 hours apart, for 6 months. Patients < 70 kg or intolerant of the highest doses received 0.5 mg/12 h followed by 0.5 mg once daily.
Recurrence at 18 months. Secondary outcomes included symptom persistence at 72 hours, remission at 1 week, disease-related hospitalization, constrictive pericarditis, cardiac tamponade, and adverse effects.
100% (intention-to-treat analysis).
Colchicine reduced recurrence at 18 months and symptom persistence at 72 hours and increased remission at 1 week but did not affect disease-related hospitalization (Table). There were no cases of constrictive pericarditis and 1 case of cardiac tamponade in the placebo group. Groups did not differ for adverse events (7% in both groups, P value > 0.99).
In patients with a first recurrence of pericarditis, adding colchicine to conventional treatment reduced recurrence and did not increase adverse effects.
†Abbreviations defined in Glossary.
‡NNT and CI calculated from control event rates and RRR in article.
§RRR, RBI, NNT, and CI calculated from event rates in article.
Bach RG. Colchicine reduced further recurrence after a first recurrence of pericarditis. Ann Intern Med. ;156:JC2–4. doi: 10.7326/0003-4819-156-4-201202210-02004
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Published: Ann Intern Med. 2012;156(4):JC2-4.
Cardiology, Pericardial Disease.
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