Dr. Andre Keren,
Dr. Massimo Imazio,
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Massimo Imazio (Italy)
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List of Authors: M. Imazio, MD, A. Brucato, MD, R. Cemin, MD, S. Ferrua, MD, R. Belli, MD, S. Maestroni, MD, R. Trinchero, MD, D.H. Spodick, Professor, Y. Adler, Professor, on behalf of the CORP Investigators.
Background: Recurrences are the most common complications of pericarditis affecting up to 50% of patients (mean 20 to 30%). Aim of the COlchicine for REcurrent pericarditis (CORE) study is to evaluate the efficacy and safety of colchicine for the secondary prevention of recurrent pericarditis. Methods: The study is a prospective, randomized, double-blind, placebo-controlled, multicenter trial. We enrolled 120 patients with a first episode of recurrent pericarditis from 4 general hospitals in Italian urban areas. Patients were randomized to receive placebo or colchicine on top of conventional treatment. Colchicine was given at the dose of 1.0-2.0 mg for the first day followed by a maintenance dose of 0.5-1.0 mg daily for 6 months. The primary study end point was the recurrence rate at 18 months. Secondary end points were symptom persistence at 72 hours, remission rate at 1 week, number of recurrences, time to first recurrence, disease-related hospitalization, cardiac tamponade, and constrictive pericarditis rates. Results: At 18 months actuarial recurrence rate was 24% in the colchicine group and 55% in the placebo group (absolute risk reduction-ARR 31% 95% confidence interval-CI 13 to 46%, relative risk reduction-RRR 56% 95% CI 27 to 73%; number needed to treat-NNT 3, 95% CI 2 to 7). Colchicine reduced the symptoms persistence at 72 hours (ARR 30% 95% CI 13 to 45%, RRR 56% 95% CI 27 to 74%), and the mean number of recurrences, increasing the remission rate at 1 week and prolonging the time to subsequent recurrence. The rate of side effects and drug withdrawal were similar in the study groups. Conclusions: When added to empiric anti-inflammatory therapy, colchicine appears to be an in-expensive and safe means to hasten symptoms resolution, improve remission rates by 1 week, and reduce recurrences following an initial episode of recurrent pericarditis. Primary Funding Source. Cardiology Department, Maria Vittoria Hospital, Torino, Italy. Clinical Trial Registration. ClinicalTrials.gov number, NCT00128414.
Discussant | see Presenter abstract
Andre Keren (Israel)
Recurrence is the most frequent complication of acute pericarditis. It occurs in 15-35% of cases and up to 50% of those with a first relapse experience a second one. Colchicine, an alkaloid drug, was effectively employed as an adjuvant to nonsteroidal (NSAIDS) and steroidal anti-inflammatory drugs in prevention of recurrences (secondary prevention) of pericarditis in observational studies and in the CORE trial, a randomized, single center, open label trial (Imazio M et al. Arch Intern Med 2005;165:1987-1991). The CORP is a double blind, multicenter, randomized placebo controlled trial aimed to evaluate the efficacy and safety of low dose Colchicine in prevention of additional relapses after a first recurrence of pericarditis. The primary end point was the recurrence rate of pericarditis at 18 months. A range of predefined secondary end points included symptoms persistence at 72 hours after initiation of therapy, remission rate at 1 week and number/timing of recurrences.
The study population included 120 eligible patients with a first recurrence of pericarditis, who received in addition to standard anti-inflammatory therapy (NSAIDS in 92% and steroids in only 8% of cases) either low dose Colchicine or placebo. All patients received preventively a proton pump inhibitor. Baseline characteristics were well balanced between the groups. The recurrence rate at 18 months was 38% in the entire cohort, 55% in the placebo and 24% in the Colchicine treated group, p<0.001, number needed to treat 3, relative risk reduction 56% and absolute risk reduction 31%. Colchicine significantly reduced symptoms at 72 hours, the mean number of recurrences, and increased the remission rate achieved at 7 days. By multivariate analysis, the only risk factor associated with further recurrences was a higher rate of pericardial effusion at the time of the first relapse (HR 4.8, 95% CI 1.8 to 12.9) while Colchicine had a protective effect (HR 0.12, 95% CI 0.05-0.32). The rate of side effects was 7% in the 2 groups and the drug withdrawal rate was also very similar (8% in the Colchicine and 5% in the placebo group, p=ns). The side effects were mainly gastrointestinal.
CORP is the first, double blind, multicenter trial which proved that Colchicine is an effective, safe and well tolerated therapy in patients with recurrent pericarditis. Despite many similarities in methodology and results, the CORP trial was not a mere "repetition" of the previous single center open label CORE trial. Compared with the CORE trial, the dose of steroids was significantly lower in the CORP trial (0.2 to 0.5mg/kg/day instead of 1.0 to 1.5 mg/kg/day). The frequency of steroid therapy instead of NSAIDS was also significantly lower in the CORP trial, both during the initial acute pericarditis episode (9% vs 35%) and during the recurrence (i.e the "study period", 8% vs 35%). The decrease in the use of steroids in the CORP trial reflecs the change in clinical practice due to the recognition of the deleterious effect steroids can have in promoting increase in recurrence rates in patients with pericarditis. The major limitation of the study is related to the relatively small number of subjects evaluated. In conjunction with previous reports the well designed and carefully performed CORP study supports the use in clinical practice of low dose Colchicine as "first line" therapy in conjunction with NSAIDS or Steroids in patients with recurrent pericarditis.
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