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Massimo Imazio, MD, FESC on behalf of the CORP-2 Investigators

Efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2): a multicentre , double - blind , placebo- controlled , randomised trial. Massimo Imazio, MD, FESC on behalf of the CORP-2 Investigators

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Massimo Imazio, MD, FESC on behalf of the CORP-2 Investigators

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  1. Efficacyand safety of colchicine for treatment of multiple recurrencesof pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomisedtrial Massimo Imazio, MD, FESC on behalf of the CORP-2 Investigators CardiologyDpt. Maria Vittoria Hospital, ASLTO2, Torino, Italy

  2. Conflicts of interest: NoneFunding:The CORP-2 trial wassupported by the former Azienda Sanitaria 3 of Torino (now ASLTO2) within the Italian National Health Service. Acarpia (Madeira, Portugal) provided the studydrug and placebo as an unrestrictedgrant. Off-label use: colchicine for pericarditisbutalsoallothertherapies (i.e. NSAID) are off-label. Thistrial isregistered with ClinicalTrials.gov, number NCT00235079.

  3. Background Clinical trials haveshownthatlow-dose colchicine (0·5–1·0 mg daily) isefficacious and safe for treatment and prevention of acute pericarditis and first recurrences. RRR 0.56 NNT=3 CORP trial Ann Intern Med 2011; 155: 409–14

  4. Heart 2012;98:1078-1082

  5. ICAP trial (Acute Pericarditis) RRR 0.56 NNT= 4 N Engl J Med 2013; 369: 1522–28

  6. CORP-2: Aim To assess the efficacy and safety of colchicine to treat patients with multiple recurrences of pericarditis (≥2). COlchicine for Recurrent Pericarditis-2 J Cardiovasc Med (Hagerstown) 2007; 8: 830–34

  7. Diagnostic criteria

  8. Methods We assumed that 30% of patients would have recurrent pericarditis in the placebo group at 18 months and estimated that colchicine could reduce the proportion of patients with recurrent pericarditis by half. With a two- sided % level of 0·05, a total enrolment of 240 patients was needed to attain power of 0·80 to detect a 15% absolute reduction in the proportion of participants who had recurrent pericarditis in the colchicine group.

  9. Inclusion criteria • Consecutive patients aged 18 years or older with two or more recurrences of pericarditis (idiopathic, viral, post-cardiac injury, or caused by connective tissue disease).

  10. Exclusioncriteria • Tuberculous, neoplastic, or purulentpericarditisetiology; • Severe liverdisease or currentaminotransferaseconcentrations more than 1·5 times the upperlimit of the normal; • Serumcreatinine concentration more than 221·00 μmol/L; • Skeletalmyopathy or serum creatine kinaseconcentration more than the upperlimit of the normal; • Blood dyscrasia; • Inflammatoryboweldisease; • Hypersensitivityto colchicine or othercontraindication to colchicine; • Currenttreatment with colchicine; • Life expectancy of 18 months or less; • Pregnantor lactatingwomen or women of childbearingpotentialnotusingcontraception; • Evidenceof myopericarditisasindicated by anyincrease of serumtroponinconcentration.

  11. (0·5 mg twice daily for 6 months for patients >70 kg or 0·5 mg once daily for patients ≤ 70 kg) in addition to conventional anti-inflammatory treatment with aspirin, ibuprofen, or indometacin.

  12. Results

  13. Trial profile Lancet 2014; published today

  14. Baseline data Lancet 2014; published today

  15. Outcomes Lancet 2014; published today

  16. Recurrence-free Survival RR 0.49 NNT= 5 Lancet 2014; published today

  17. Safety: side effects Lancet 2014; published today

  18. Study limitations • Specificpopulationswereexcluded (children, pregnant or lactatingwomen, and patients with potentialcontraindications or at high risk of complicationsafter the administration of colchicine). • Specificetiologies of pericarditiswerealsoexcluded (bacterialor neoplasticpericarditis). • Thus, ourresultsshouldonly be applied to populationsthatwereeligible for the study. • At present, colchicine isnotapproved for treatment of recurrentpericarditis in North America or Europe, and its use assuchis off-label. • Studysample size and length of follow-up mighthaveprecludedidentification of rare adverseeffects or long-termeffects of the drug. • Arbitrarylength of therapy for colchicine (6 months): furtherresearchisneeded to identify the best duration of colchicine treatment for recurrences. A longer treatment duration (6–12 months) mightfurtherdecreaserecurrences.

  19. Conclusions • Colchicine added to conventional anti-inflammatory treatment significantlyreduced the rate of subsequentrecurrences of pericarditis in patients with multiple recurrences. • Takentogether with results from otherrandomisedcontrolled trials, thesefindingssuggestthat colchicine should be probablyregardedas a first-line treatment for either acute or recurrentpericarditis in the absence of contrandications.

  20. Full paper published online today

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