Efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomised trial

摘要: Summary Background Colchicine is effective for the treatment of acute pericarditis and first recurrences. However, conclusive data are lacking efficacy safety colchicine multiple recurrences pericarditis. Methods We did this multicentre, double-blind trial at four general hospitals in northern Italy. Adult patients with (≥two) were randomly assigned (1:1) to placebo or (0·5 mg twice daily 6 months weighing more than 70 kg 0·5 once less) addition conventional anti-inflammatory aspirin, ibuprofen, indometacin. Permuted block randomisation (size four) was done a central computer-based automated sequence. Patients all investigators masked allocation. The primary outcome recurrent intention-to-treat population. This registered ClinicalTrials.gov, number NCT00235079. Findings 240 enrolled 120 each group. proportion who had 26 (21·6%) group 51 (42·5%) (relative risk 0·49; 95% CI 0·24–0·65; p=0·0009; needed treat 5). Adverse effects discontinuation study drug occurred much same proportions most common adverse events gastrointestinal intolerance (nine vs nine group) hepatotoxicity (three one). No serious reported. Interpretation added significantly reduced rate subsequent Taken together results from other randomised controlled trials, these findings suggest that should be probably regarded as first-line either absence contraindications specific indications. Funding Azienda Sanitaria 3 Torino (now ASLTO2).