TY - JOUR
T1 - Effi cacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2)
T2 - A multicentre, double-blind, placebo-controlled, randomised trial
AU - Imazio, Massimo
AU - Belli, Riccardo
AU - Brucato, Antonio
AU - Cemin, Roberto
AU - Ferrua, Stefania
AU - Beqaraj, Federico
AU - Demarie, Daniela
AU - Ferro, Silvia
AU - Forno, Davide
AU - Maestroni, Silvia
AU - Cumetti, Davide
AU - Varbella, Ferdinando
AU - Trinchero, Rita
AU - Spodick, David H.
AU - Adler, Yehuda
N1 - Funding Information:
The CORP-2 trial was supported by the former Azienda Sanitaria 3 of Torino (now ASLTO2) within the Italian National Health Service. Acarpia (Madeira, Portugal) provided the study drug and placebo as an unrestricted grant.
PY - 2014
Y1 - 2014
N2 - Background Colchicine is eff ective for the treatment of acute pericarditis and fi rst recurrences. However, conclusive data are lacking for the effi cacy and safety of colchicine for treatment of multiple recurrences of pericarditis. Methods We did this multicentre, double-blind trial at four general hospitals in northern Italy. Adult patients with multiple recurrences of pericarditis (.two) were randomly assigned (1:1) to placebo or colchicine (OE5 mg twice daily for 6 months for patients weighing more than 70 kg or 0E5 mg once daily for patients weighing 70 kg or less) in addition to conventional anti-infl ammatory treatment with aspirin, ibuprofen, or indometacin. Permuted block randomisation (size four) was done with a central computer-based automated sequence. Patients and all investigators were masked to treatment allocation. The primary outcome was recurrent pericarditis in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00235079. Findings 240 patients were enrolled and 120 were assigned to each group. The proportion of patients who had recurrent pericarditis was 26 (21E6%) of 120 in the colchicine group and 51 (42E5%) of 120 in the placebo group (relative risk 0E49; 95% CI 0E24.0E65; p=0E0009; number needed to treat 5). Adverse eff ects and discontinuation of study drug occurred in much the same proportions in each group. The most common adverse events were gastrointestinal intolerance (nine patients in the colchicine group vs nine in the placebo group) and hepatotoxicity (three vs one). No serious adverse events were reported. Interpretation Colchicine added to conventional anti-infl ammatory treatment signifi cantly reduced the rate of subsequent recurrences of pericarditis in patients with multiple recurrences. Taken together with results from other randomised controlled trials, these fi ndings suggest that colchicine should be probably regarded as a fi rst-line treatment for either acute or recurrent pericarditis in the absence of contraindications or specifi c indications. Funding Azienda Sanitaria 3 of Torino (now ASLTO2).
AB - Background Colchicine is eff ective for the treatment of acute pericarditis and fi rst recurrences. However, conclusive data are lacking for the effi cacy and safety of colchicine for treatment of multiple recurrences of pericarditis. Methods We did this multicentre, double-blind trial at four general hospitals in northern Italy. Adult patients with multiple recurrences of pericarditis (.two) were randomly assigned (1:1) to placebo or colchicine (OE5 mg twice daily for 6 months for patients weighing more than 70 kg or 0E5 mg once daily for patients weighing 70 kg or less) in addition to conventional anti-infl ammatory treatment with aspirin, ibuprofen, or indometacin. Permuted block randomisation (size four) was done with a central computer-based automated sequence. Patients and all investigators were masked to treatment allocation. The primary outcome was recurrent pericarditis in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00235079. Findings 240 patients were enrolled and 120 were assigned to each group. The proportion of patients who had recurrent pericarditis was 26 (21E6%) of 120 in the colchicine group and 51 (42E5%) of 120 in the placebo group (relative risk 0E49; 95% CI 0E24.0E65; p=0E0009; number needed to treat 5). Adverse eff ects and discontinuation of study drug occurred in much the same proportions in each group. The most common adverse events were gastrointestinal intolerance (nine patients in the colchicine group vs nine in the placebo group) and hepatotoxicity (three vs one). No serious adverse events were reported. Interpretation Colchicine added to conventional anti-infl ammatory treatment signifi cantly reduced the rate of subsequent recurrences of pericarditis in patients with multiple recurrences. Taken together with results from other randomised controlled trials, these fi ndings suggest that colchicine should be probably regarded as a fi rst-line treatment for either acute or recurrent pericarditis in the absence of contraindications or specifi c indications. Funding Azienda Sanitaria 3 of Torino (now ASLTO2).
UR - http://www.scopus.com/inward/record.url?scp=84903315817&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(13)62709-9
DO - 10.1016/S0140-6736(13)62709-9
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C2 - 24694983
AN - SCOPUS:84903315817
SN - 0140-6736
VL - 383
SP - 2232
EP - 2237
JO - The Lancet
JF - The Lancet
IS - 9936
ER -