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including those with additional therapy such as non-steroidal anti-inflammatory drugs &#40;NSAIDs&#41; or steroids&#44; and any type of control&#44; whether inactive &#40;placebo&#41; or active &#40;e&#46;g&#46; aspirin&#44; NSAIDs or steroids&#41;&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The following databases were searched&#58; Cochrane Central Register of Controlled Trials &#40;CENTRAL&#44; July 2014 issue&#41;&#44; MEDLINE &#40;1946 to 2014&#41;&#44; EMBASE &#40;1947 to 2014&#41;&#44; Conference Proceedings Citation Index-Science on Web of Science &#40;1990 to 2014&#41;&#44; and databases of international registries of clinical trials &#40;International Clinical Trials Registry Platform Search Portal&#44; ClinicalTrials&#46;gov&#44; and European Union Clinical Trials Register&#41;&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Data were pooled in meta-analyses&#46; Hazard ratios &#40;HR&#41; with 95&#37; confidence intervals &#40;CI&#41; were used to express events such as time until the first recurrence of pericarditis and dichotomous variables were expressed as risk ratios &#40;RR&#41; with 95&#37; CI&#46; In cases of statistical significance the number needed to treat &#40;NNT&#41; was calculated&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Results</span><p id="par0030" class="elsevierStylePara elsevierViewall">Four trials were included&#44; with follow-up ranging from 20 to 24 months&#46; Two were open-label&#44; with controls receiving the anti-inflammatory therapy recommended for pericarditis&#44; and two were double-blind and placebo-controlled&#46; A total of 564 participants were included &#40;64&#37; with acute and 36&#37; with recurrent pericarditis&#41;&#44; most of the latter &#40;&#62;75&#37;&#41; diagnosed with idiopathic pericarditis&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">All participants received aspirin at cumulative doses of 2&#46;4&#8211;3&#46;2 g daily for a week&#44; gradually tapered down over a period of 3&#8211;4 weeks&#46; In two trials&#44; ibuprofen 600 mg in three daily doses was additionally offered as an alternative to aspirin&#46; People who had contraindications to aspirin received steroids&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Colchicine was administered orally&#44; and in three trials was given at a loading dose of 1 mg every 12 hours for the first day&#46; A maintenance dose of 0&#46;5 mg twice daily &#40;once daily for those weighing &#60;70 kg&#41; was then continued for three months in patients with acute pericarditis and six months in those with recurrent pericarditis&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Colchicine significantly reduced time to recurrence in patients with acute pericarditis &#40;HR 0&#46;40&#59; 95&#37; CI &#40;0&#46;27&#8211;0&#46;61&#41; and in those with recurrent pericarditis &#40;HR 0&#46;37&#59; 95&#37; CI &#40;0&#46;24&#8211;0&#46;58&#41;&#46; At 18 months there was a significant reduction in RR of recurrence in patients with acute and recurrent pericarditis &#40;59&#37; and 62&#37;&#44; respectively&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#41;&#46; The NNT was 5 for acute &#91;pericarditis&#93; and 4 for recurrent pericarditis&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0050" class="elsevierStylePara elsevierViewall">Colchicine reduced the RR of persistent chest pain by 29&#37; at 72 hours &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#41;&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">With regard to tolerability&#44; total adverse events were not significantly more frequent with colchicine than in controls&#44; but significantly more patients discontinued therapy due to adverse effects &#40;RR 1&#46;87&#59; 95&#37; CI 1&#46;02&#8211;3&#46;41&#41;&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Conclusions</span><p id="par0060" class="elsevierStylePara elsevierViewall">Colchicine as adjunctive therapy to aspirin or NSAIDs at high doses is effective in reducing recurrences in patients with acute or recurrent pericarditis&#46; However&#44; it should be borne in mind that the number of trials on this subject is low and the quality of evidence is sub-optimal&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Comment</span><p id="par0065" class="elsevierStylePara elsevierViewall">Colchicine is one of the oldest drugs still in the current therapeutic arsenal&#46; It is widely used for the treatment and prevention of acute gout&#44; and its usefulness in other areas is beginning to be explored&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">After oral ingestion it has 44&#37; bioavailability&#44; with peak plasma concentration after one hour&#44; and is mainly excreted by the liver&#46; After entering the circulation&#44; colchicine concentrates in leukocytes&#44; where it performs the functions for which it is indicated&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">2</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">Colchicine interferes with microtubule dynamics&#44; inhibiting mitosis and neutrophil motility&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">2</span></a> It has additional anti-inflammatory action to that of the standard anti-inflammatories &#40;steroids and NSAIDs&#41;&#44; since its mechanism of action does not involve the arachidonic acid pathway&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">2</span></a> The most recent guidelines of the European Society of Cardiology on the diagnosis and management of pericardial diseases &#40;2004&#41; state that colchicine appears to be effective for the treatment of acute pericarditis &#40;class IIa recommendation&#44; level of evidence B&#41; and recurrent pericarditis &#40;class I recommendation&#44; level of evidence B&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">3</span></a></p><p id="par0080" class="elsevierStylePara elsevierViewall">The best available evidence indicates that colchicine significantly reduces the proportion of symptomatic patients after three days of treatment and the long-term recurrence rate&#44; with large reductions in both relative and absolute risk&#46; However&#44; it is associated with a significantly higher rate of discontinuation due to adverse effects&#44; but the fact that total adverse events did not differ from controls&#44; together with the drug&#39;s potential clinical benefit&#44; should be weighed against this disadvantage&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">The trials under review excluded all patients with pericarditis of bacterial&#44; tuberculous or neoplastic origin&#44; active or severe liver disease&#44; severe renal dysfunction &#40;serum creatinine &#62;2&#46;5 mg&#47;dl&#41;&#44; myopathy&#44; bleeding dyscrasia or inflammatory intestinal disease&#46; They also excluded patients with resistant multiple recurrences or with myopericarditis&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Clinical implications</span><p id="par0090" class="elsevierStylePara elsevierViewall">When added to NSAIDs&#44; colchicine reduced persistent symptoms in the short term and the risk of recurrence in the long term in patients with acute pericarditis &#40;maintenance dose for three months&#41; or recurrent &#40;maintenance dose for six months&#41;&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">Dosages adjusted for body weight &#40;0&#46;5 mg twice daily for patients weighing &#8805;70 kg and once daily for those weighing &#60;70 kg&#41; appear to have acceptable tolerability&#46; However&#44; due to the potential cumulative risk of iatrogenic gastrointestinal adverse effects with concomitant colchicine and NSAIDs&#44; proton pump inhibitors are recommended in all patients&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">Colchicine has not been formally approved for the treatment and&#47;or prevention of events in acute or recurrent pericarditis&#44; and so its use in this context must be considered off-label&#44; despite the existence of moderate quality evidence supporting a favorable risk-benefit ratio&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Ethical disclosures</span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Protection of human and animal subjects</span><p id="par0105" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed on humans or animals for this investigation&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Confidentiality of data</span><p id="par0110" class="elsevierStylePara elsevierViewall">The authors declare that no patient data appears in this article&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Right to privacy and informed consent</span><p id="par0115" class="elsevierStylePara elsevierViewall">The authors declare that no patient data appears in this article&#46;</p></span></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Conflicts of interest</span><p id="par0120" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare&#46;</p></span></span>"
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