KT Evidence Bite: Colchicine for Pericarditis

Editor’s note: This is a series based on work done by three physicians (Patrick Archambault, Tim Chaplin, and our BoringEM Managing editor Teresa Chan) for the Canadian National Review Course (NRC). You can read a description of this course here.

The NRC brings EM residents from across the Canada together in their final year for a crash course on everything emergency medicine. Since we are a specialty with heavy allegiance to the tenets of Evidence-Based Medicine, we thought we would serially release the biggest, baddest papers in EM to help the PGY5s in their studying via a spaced-repetition technique. And, since we’re giving this to them, we figured we might as well share those appraisals with the #FOAMed community! We have kept much of the material as drop downs so that you can quiz yourself on the studies.

Paper: A Randomized Trial of Colchicine for Acute Pericarditis

Citation:

Imazio, Massimo, et al. “A randomized trial of colchicine for acute pericarditis.”New England Journal of Medicine 369.16 (2013): 1522-1528. PMID: 23992557

Summarized by: Patrick Archambault
Reviewed by: Teresa Chan & Tim Chaplin

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Clinical Question

Is colchicine effective in treating a first attack of acute pericarditis and in the prevention of recurrent symptoms?

Population	18 years of age or older with a first episode of acute pericarditis* (idiopathic, viral, after cardiac injury, or associated with connective-tissue disease). Exclusion criteria: tuberculous, neoplastic, or purulent pericarditis; severe liver disease or current aminotransferase levels of more than 1.5 times the upper limit of the normal range; a serum creatinine level of more than 2.5 mg per deciliter (221 μmol per liter); skeletal myopathy or a serum creatine kinase level above the upper limit of the normal range; blood dyscrasia; inflammatory bowel disease; hypersensitivity to colchicine or other contraindication to its use
Intervention	Colchicine was administered at a dose of 0.5 to 1.0 mg daily for 3 months. Dose was based on weight: 0.5mg BID if >70kg, 0.5mg ID if < 70kg All patients also received: (1) NSAIDS (ASA 800 mg TID or ibuprofen 600mg TID) for 7-10 days tapered over 3-4 weeks OR (2) prednisone (0.2-0.5 mg/kg daily if NSAIDS were contraindicated) for 2 weeks with gradual tapering AND a PPI for gastrointestinal prophylaxis.
Control	placebo AND NSAIDS (or prednisone) AND PPI
Outcome	1) Incessant (recurrence < 6 weeks after first attack) or recurrent pericarditis (after a 6-week symptom free period) 2) Symptom persistence at 72 hours, remission within 1 week, number of recurrences, the time to the first recurrence, disease-related hospitalization, cardiac tamponade, and constrictive pericarditis

Methods

This was a randomized, double-blind trial, with intention-to-treat analysis

Results

n=240

Primary outcome (rate of incessant/recurrent pericarditis)

Colchicine: 20 patients (16.7%) vs. Placebo: 45 patients (37.5%)
RRR in the colchicine group, 0.56; 95%CI, 0.30 to 0.72 (P<0.001)
NNT=4

Secondary outcomes

Lower rate of symptom persistence at 72 hours in the colchicine group (19.2% vs. 40.0%, P = 0.001)
Lower number of recurrences per patient in the colchicine group (0.21 vs. 0.52, P = 0.001)
Reduced hospitalization rate in the colchicine group (5.0% vs. 14.2%, P = 0.02)
Higher remission rate at 1 week in the colchicine group (85.0% vs. 58.3%, P<0.001)
No serious adverse events were observed

Conclusions

Colchicine in addition to conventional antiinflammatory therapy significantly reduced the rate of incessant or recurrent pericarditis, reduced the number of recurrences of pericarditis, and prolonged the time to recurrence, as compared with placebo.

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Take Home Point

Colchicine is safe and effective to use in acute pericarditis (of idiopathic, viral and autoimmune etiologies).

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EBM Considerations

Sample size: Small study with 240 patients (120 in each arm), that was however adequately powered to detect a large reduction in incessant and recurrent pericarditis
Side effects: Although there were no differences in rates of adverse events, diarrhea was the major limiting side effect associated with colchicine and was reported in less than 10% of patients, and no serious adverse events were recorded.
Generalizability: Colchicine was not used in bacterial or neoplastic pericarditis so use cannot be easily extrapolated to use in these disease conditions.

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For a pdf version of this summary click NRC – BoringEM – Colchicine for Pericarditis