Colchicine reduced further recurrence after a first recurrence of pericarditis

Bach RG. — Tue, 21 Feb 2012 00:00:00 GMT

Question

In patients with a first recurrence of pericarditis, what are the efficacy and safety of adding colchicine to conventional treatment to prevent further recurrence?

Methods

Design

Randomized placebo-controlled trial (COlchine for Recurrent Pericarditis [CORP]). ClinicalTrials.gov NCT00128414.

Allocation

Concealed.*

Blinding

Blinded (patients, clinicians, outcome assessors, and monitoring committee).*

Follow-up period

Mean 23 months.

Setting

4 general hospitals in Italy.

Patients

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.

Intervention

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.

Outcomes

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.

Patient follow-up

100% (intention-to-treat analysis).

Main results

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).

Conclusion

In patients with a first recurrence of pericarditis, adding colchicine to conventional treatment reduced recurrence and did not increase adverse effects.

Colchicine vs placebo in patients with recurrent pericarditis†

OutcomesColchicinePlaceboRRR (95% CI)NNT (CI)Recurrence at 18 mo24%55%56% (27 to 73)4 (3 to 7)‡Symptom persistence at 72 h23%53%56% (27 to 74)4 (3 to 7)‡Disease-related hospitalization5%13%63% (−23 to 89)§Not significant§RBI (CI)NNT (CI)Remission at 1 wk82%48%69% (29 to 130)§3 (2 to 6)§†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.

Annals of Internal Medicine: Pericardial Disease Topic Collection

Colchicine reduced further recurrence after a first recurrence of pericarditis