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Cited by 611Pericarditis and Cardiac TamponadeStreptococcal Infections and TreatmentsInflammasome and immune disorders

A Randomized Trial of Colchicine for Acute Pericarditis

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Imazio, Massimo, Brucato, Antonio, Cemin, Roberto, Ferrua, Stefania, Maggiolini, Stefano, Beqaraj, Federico, Demarie, Daniela, Forno, Davide +6 more·2013·New England Journal of Medicine
DOI 10.1056/nejmoa1208536
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Abstract

BACKGROUND: Colchicine is effective for the treatment of recurrent pericarditis. However, conclusive data are lacking regarding the use of colchicine during a first attack of acute pericarditis and in the prevention of recurrent symptoms. METHODS: In a multicenter, double-blind trial, eligible adults with acute pericarditis were randomly assigned to receive either colchicine (at a dose of 0.5 mg twice daily for 3 months for patients weighing >70 kg or 0.5 mg once daily for patients weighing ≤70 kg) or placebo in addition to conventional antiinflammatory therapy with aspirin or ibuprofen. The primary study outcome was incessant or recurrent pericarditis. RESULTS: A total of 240 patients were enrolled, and 120 were randomly assigned to each of the two study groups. The primary outcome occurred in 20 patients (16.7%) in the colchicine group and 45 patients (37.5%) in the placebo group (relative risk reduction in the colchicine group, 0.56; 95% confidence interval, 0.30 to 0.72; number needed to treat, 4; P<0.001). Colchicine reduced the rate of symptom persistence at 72 hours (19.2% vs. 40.0%, P=0.001), the number of recurrences per patient (0.21 vs. 0.52, P=0.001), and the hospitalization rate (5.0% vs. 14.2%, P=0.02). Colchicine also improved the remission rate at 1 week (85.0% vs. 58.3%, P<0.001). Overall adverse effects and rates of study-drug discontinuation were similar in the two study groups. No serious adverse events were observed. CONCLUSIONS: In patients with acute pericarditis, colchicine, when added to conventional antiinflammatory therapy, significantly reduced the rate of incessant or recurrent pericarditis. (Funded by former Azienda Sanitaria Locale 3 of Turin [now Azienda Sanitaria Locale 2] and Acarpia; ICAP ClinicalTrials.gov number, NCT00128453.).

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  • Pre-COVID pericarditis occurs more often in young men under 50 years with a sex ratio of around 2:1.

    “Similar to myocarditis, preCOVID pericarditis occurs more often in young men under the age of 50 years with a sex ratio of around 2:1. 64,95,118”

    From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [118]

    The Patients section (p. 4) reports that 60% of trial participants were male, supporting a male predominance. But their mean age was 52.1 years, and the paper does not establish that pericarditis occurs more often under age 50; 60% male also corresponds to roughly 1.5:1, not 2:1. The trial's participants do not establish population-wide occurrence rates. (LLM, conf=0.87)

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  • The prognosis for viral or idiopathic pericarditis is good, based primarily on the effectiveness of colchicine combined with anti-inflammatories as therapies.

    “The prognosis for viral or idiopathic pericarditis is good, based primarily on the effectiveness of colchicine combined with anti-inflammatories as therapies. 118,133”

    From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [118]

    The Eligibility Criteria (p. 2) include patients with idiopathic or viral acute pericarditis, and the Discussion (p. 5) reports that adding colchicine to anti-inflammatory therapy reduced persistent or recurrent disease. The paper does not establish that their overall prognosis is good or that it is good primarily because of this treatment. (LLM, conf=0.84)

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Research works printed but not linked: 22

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Authors
Imazio, M., Brucato, A., Cemin, R., Ferrua, S., Maggiolini, S., Beqaraj, F., Demarie, D., Forno, D., Ferro, S., Maestroni, S., Belli, R., Trinchero, R., Spodick, D. H., & Adler, Y.
Affiliations
  • Ospedale Maria Vittoria (IT)
  • Ospedale Papa Giovanni XXIII (IT)
  • Ospedale di Bolzano (IT)
  • Saint Vincent Hospital (US)
  • Sheba Medical Center (IL)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2013-10-17
Volume
369
Issue
16
Pages
1522-1528
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1208536
OpenAlex
W2129554354
Cited by
611
References
0
Citations by year
2026: 56 · 2025: 50 · 2024: 48 · 2023: 64 · 2022: 44 · 2021: 78 · 2020: 52 · 2019: 44 · 2018: 26 · 2017: 26 · 2016: 31 · 2015: 46 · 2014: 43 · 2013: 3
FWCI
27.72
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Institutional Research Information System (University of Udine) (submittedVersion)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Pericarditis and Cardiac Tamponade
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Streptococcal Infections and Treatments
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Inflammasome and immune disorders
Keywords
colchicine, acute pericarditis, recurrent pericarditis, anti-inflammatory therapy, aspirin, ibuprofen, symptom remission, hospitalization, adverse effects
MeSH terms
Acute Disease, Adolescent, Adult, Aged, Anti-Inflammatory Agents, Aspirin, Colchicine, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Ibuprofen, Male, Middle Aged, Pericarditis, Prednisone, Kaplan-Meier Estimate, Secondary Prevention, Young Adult

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