02 Sep Acute Pericarditis: Study of Colchicine for Treatment and Prevention
MedicalResearch.com Interview with:
Massimo Imazio, MD, FESC
Dipartimento di Cardiologia/Cardiology Department
Maria Vittoria Hospital-ASLTO2
via Cibrario 72 10141 Torino, Italy
MedicalResearch.com: What are the main findings of the study?
Dr. Imazio: In a multicenter, double-blind trial, eligible adults with acute pericarditis (idiopathic/viral, post-pericardiotomy syndromes and pericarditis related to a systemic inflammatory disease) 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 anti-inflammatory therapy with aspirin or ibuprofen. The primary study outcome was incessant or recurrent pericarditis.
After a mean follow-up of 22 months (minimum 18 months) 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).
MedicalResearch.com: Were any of the findings unexpected?
Dr. Imazio: Colchicine is able to halve recurrences also in the setting of acute pericarditis as well as after a first recurrence of pericarditis (CORP trial result. Annals of Internal Medicine 2011). Moreover colchicine may also reduce pericarditis-related hospitalizations and may contribute to reduce management costs.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Imazio: Most treatments are empirical in the setting of pericarditis. At present, colchicine is the most studied drug in this field, and we have enough evidence (an open label randomised trial, the COPE trial and a multicenter double blind randomised trial-present ICAP study), in my view, to support its use in acute pericarditis (first episode) as well as for the first recurrence of pericarditis after the index attack as supported by the previously published CORP trial.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Imazio: We still need additional evidence in patients with multiple recurrences but data from the CORP-2 trial will be available soon next year and will address this remaining issue.
The best treatment length is unknown and we may speculate that longer treatments (>3 months) may further reduce the proportion of recurrences during follow-up. Additional research may be needed on this issue.
Moreover we need basic research to better address the mechanism of colchicine action in acute and recurrent pericarditis.
Current guidelines recommend colchicine doses of 2 mg per day for 1 to 2 days, followed by a maintenance dose of 1 mg per day 18. However, lower doses may improve patient compliance and be equally efficacious.
The COPE, CORE, and CORP trials used a maintenance dose of 0.5 mg
twice daily, which was reduced to 0.5 mg daily in patients weighing less than 70 kg. In our study, a loading dose was not given, and patients had similar side effects in the colchicine and placebo
groups, a finding that supports the use of a weight-adjusted maintenance dose without any loading dose.
As final comments, I would like to add that a number of limitations of our study should be considered. Our findings might not be generalizable to other clinical conditions or other patient
populations; in this regard, we excluded patients with elevated levels of aminotransferases, creatinine, or troponin and those with liver disease, myopathy, blood dyscrasias, or inflammatory
bowel disease. Our results should not be applied to women who are pregnant or lactating or to children. We also excluded patients with bacterial or neoplastic pericarditis.
Of note, colchicine is not approved for the prevention of recurrent pericarditis in North America or Europe, and its use as such is off-label. Our limited sample size might have precluded the identification of rare adverse effects.
Massimo Imazio, M.D., Antonio Brucato, M.D., Roberto Cemin, M.D., Stefania Ferrua, M.D., Stefano Maggiolini, M.D., Federico Beqaraj, M.D., Daniela Demarie, M.D., Davide Forno, M.D., Silvia Ferro, M.D., Silvia Maestroni, M.D., Riccardo Belli, M.D., Rita Trinchero, M.D., David H. Spodick, M.D., and Yehuda Adler, M.D. for the ICAP Investigators