A Randomized Trial of Colchicine for Acute Pericarditis

Imazio, Massimo; Brucato, Antonio; Cemin, Roberto; Ferrua, Stefania; Maggiolini, Stefano; Beqaraj, Federico; Demarie, Daniela; Forno, Davide; Ferro, Silvia; Maestroni, Silvia; Belli, Riccardo; Trinchero, Rita; Spodick, David H.; Adler, Yehuda

doi:10.1056/nejmoa1208536

Cited by 425 publications

(342 citation statements)

References 22 publications

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“…Previous studies have reported conflicting results on the effect of sex on the risk of pericarditis. [5][6][7] A recent randomized trial of 240 patients with acute pericarditis found 60% were male, 6 whereas previous studies have reported higher male prominence 7 but also female prominence. 5 We found 65% of 1361 patients to be male, and the age-adjusted likelihood of an acute pericarditis patient being male was 1.9.…”

Section: Discussionmentioning

confidence: 98%

“…1,2 Experimental studies have found males to be at higher risk for acute viral heart disease, 3,4 but clinical studies have reported conflicting results on sex distribution of acute pericarditis patients. [5][6][7] It is commonly thought that there is no specific sex predisposition to pericarditis. 8 Murine studies have also found the susceptibility for viral heart disease to be significantly age dependent, with the highest sensitivity at adolescence or young adulthood.…”

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confidence: 99%

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Clinical Profile and Influences on Outcomes in Patients Hospitalized for Acute Pericarditis

2014

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Background-The clinical profile with regard to sex and the influences on outcomes in patients who have been hospitalized for acute pericarditis is largely uncharacterized. Methods and Results-We studied all patients aged ≥16 years admitted to the hospital because of acute pericarditis (postpericardiotomy and myocardial infarction associated pericarditis were excluded). Data were collected from a Finnish national registry that included data on all cardiovascular admissions (670 409

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Section: Discussionmentioning

confidence: 98%

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confidence: 99%

Clinical Profile and Influences on Outcomes in Patients Hospitalized for Acute Pericarditis

2014

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“…The presence of elevated inflammatory markets (C-reactive protein and/or erythrocyte sedimentation rate) can be used to confirm the diagnosis (Table 1). 11,12 Hospitalization is recommended when any of the following is present: 38 o C fever, sub-acute onset, use of anticoagulation, immunosuppression, hypotension, distention and significant effusion. evidence of rheumatic activity such as ANF and RF should be guided by clinical suspicion of autoimmune disease.…”

Section: Diagnosismentioning

confidence: 99%

“…The duration of colchicine treatment was 6 months. 17 Recently, evidence of the ICAP randomized trial 11 involving patients with a first episode of pericarditis, strongly supported this recommendation.…”

Section: 14mentioning

confidence: 99%

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Acute pericarditis

Tonini

Melo²,

Fernandes³

2015

Rev. Assoc. Med. Bras.

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Conflict of interest: noneAcute pericarditis is a common disease caused by inflammation of the pericardium, usually benign and self-limited and can occur as an isolated or as a manifestation of a systemic disease entity. Represents 5% of all causes of chest pain in the emergency room. The main etiology are viral infections, although it can also be secondary to systemic diseases and infections. The main complication of acute pericarditis is pericardial effusion, triggering a cardiac tamponade. The first line of treatment is the use of anti-inflammatory and or acetylsalicylic acid. Most patients have a good initial response to an NSAID associated to colchicine and became asymptomatic within a few days. This review article seeks to contemplate the main clinical findings and armed investigation to optimize the diagnosis of this important disease, as well as addressing their therapeutic management.Keywords: acute pericarditis, pericardial effusion, chest pain, colchicine. clinical definitionThe pericardium is a fibroelastic sac composed of two layers (visceral and parietal), separated by a virtual space called the pericardial cavity, which is filled with 15 to 50 mL of plasma ultrafiltrate in healthy subjects. Acute pericarditis is a common disease caused by inflammation of the pericardium, usually benign and selflimited, and may occur as an isolated entity or as a manifestation of a systemic disease.The real incidence and prevalence of pericarditis is difficult to quantify. Necropsy studies suggest a prevalence of approximately 1%. It affects mainly young males (aged between twenty and fifty years) without previous pathologies and represents 5% of all causes of chest pain in the emergency room. In developed countries, about 80-90% of cases are idiopathic, assuming that its main etiology is viral infection, although it can also be secondary to systemic diseases and infections.

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Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation

Imazio

Brucato

Ferrazzi

et al. 2014

JAMA

283

202

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MD; for the COPPS-2 Investigators IMPORTANCE Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postop-erative effusions may be responsible for increased morbidity and health care costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial. OBJECTIVE To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome, postoperative AF, and postoperative pericardial or pleural effusions. DESIGN, SETTING, AND PARTICIPANTS Investigator-initiated, double-blind, placebo-controlled, randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014. At enrollment, mean age of the trial participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had planned valvular surgery. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine. INTERVENTIONS Patients were randomized to receive placebo (n=180) or colchicine (0.5 mg twice daily in patients 70 kg or 0.5 mg once daily in patients <70 kg; n=180) starting between 48 and 72 hours before surgery and continued for 1 month after surgery. MAIN OUTCOMES AND MEASURES Occurrence of postpericardiotomy syndrome within 3 months; main secondary study end points were postoperative AF and pericardial or pleural effusion. RESULTS The primary end point of postpericardiotomy syndrome occurred in 35 patients (19.4%) assigned to colchicine and in 53 (29.4%) assigned to placebo (absolute difference, 10.0%; 95% CI, 1.1%-18.7%; number needed to treat = 10). There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF (colchicine, 61 patients [33.9%]; placebo, 75 patients [41.7%]; absolute difference, 7.8%; 95% CI, −2.2% to 17.6%) or postoperative pericardial/pleural effusion (colchicine, 103 patients [57.2%]; placebo, 106 patients [58.9%]; absolute difference, 1.7%; 95% CI, −8.5% to 11.7%), although there was a reduction in postoperative AF in the prespecified on-treatment analysis (placebo, 61/148 patients [41.2%]; colchicine, 38/141 patients [27.0%]; absolute difference, 14.2%; 95% CI, 3.3%-24.7%). Adverse events occurred in 21 patients (11.7%) in the placebo group vs 36 (20.0%) in the colchicine group (absolute difference, 8.3%; 95% CI; 0.76%-15.9%; number needed to harm = 12), but discontinuation rates were similar. No serious adverse events were observed. CONCLUSIONS AND RELEVANCE Among patients undergoing cardiac surgery, perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion. The increased risk of gastro-intestinal adverse effects reduced the potential benefits of colchicine in this setting.

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A Randomized Trial of Colchicine for Acute Pericarditis

Cited by 425 publications

References 22 publications

Clinical Profile and Influences on Outcomes in Patients Hospitalized for Acute Pericarditis

Clinical Profile and Influences on Outcomes in Patients Hospitalized for Acute Pericarditis

Acute pericarditis

Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation

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