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Meta-Analysis
. 2016 Jan 27;2016(1):CD011047.
doi: 10.1002/14651858.CD011047.pub2.

Colchicine for prevention of cardiovascular events

Lars G Hemkens  1 , Hannah Ewald, Viktoria L Gloy, Armon Arpagaus, Kelechi K Olu, Mark Nidorf, Dominik Glinz, Alain J Nordmann, Matthias Briel
Affiliations
Meta-Analysis

Colchicine for prevention of cardiovascular events

Lars G Hemkens et al. Cochrane Database Syst Rev. .

Abstract

Background: Colchicine is an anti-inflammatory drug that is used for a wide range of inflammatory diseases. Cardiovascular disease also has an inflammatory component but the effects of colchicine on cardiovascular outcomes remain unclear. Previous safety analyses were restricted to specific patient populations.

Objectives: To evaluate potential cardiovascular benefits and harms of a continuous long-term treatment with colchicine in any population, and specifically in people with high cardiovascular risk.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ClinicalTrials.gov, WHO International Clinical Trials Registry, citations of key papers, and study references in January 2015. We also contacted investigators to gain unpublished data.

Selection criteria: Randomised controlled trials (parallel-group or cluster design or first phases of cross-over studies) comparing colchicine over at least six months versus any control in any adult population.

Data collection and analysis: Primary outcomes were all-cause mortality, myocardial infarction, and adverse events. Secondary outcomes were cardiovascular mortality, stroke, heart failure, non-scheduled hospitalisations, and non-scheduled cardiovascular interventions. We conducted predefined subgroup analyses, in particular for participants with high cardiovascular risk. .

Main results: We included 39 randomised parallel-group trials with 4992 participants. Colchicine had no effect on all-cause mortality (RR 0.94, 95% CI 0.82 to 1.09; participants = 4174; studies = 30; I² = 27%; moderate quality of evidence). There is uncertainty surrounding the effect of colchicine in reducing cardiovascular mortality (RR 0.34, 95% CI 0.09 to 1.21, I² = 9%; participants = 1132; studies = 7; moderate quality of evidence). Colchicine reduced the risk for total myocardial infarction (RR 0.20, 95% CI 0.07 to 0.57; participants = 652; studies = 2; moderate quality of evidence). There was no effect on total adverse events (RR 1.52, 95% CI 0.93 to 2.46; participants = 1313; studies = 11; I² = 45%; very low quality of evidence) but gastrointestinal intolerance was increased (RR 1.83, 95% CI 1.03 to 3.26; participants = 1258; studies = 11; I² = 74%; low quality of evidence). Colchicine showed no effect on heart failure (RR 0.62, 95% CI 0.10 to 3.88; participants = 462; studies = 3; I² = 45%; low quality of evidence) and no effect on stroke (RR 0.38, 95% CI 0.09 to 1.70; participants = 874; studies = 3; I² = 45%; low quality of evidence). Reporting of serious adverse events was inconsistent; no event occurred over 824 patient-years (4 trials). Effects on other outcomes were very uncertain. Summary effects of RCTs specifically focusing on participants with high cardiovascular risk were similar (4 trials; 1230 participants).

Authors' conclusions: There is much uncertainty surrounding the benefits and harms of colchicine treatment. Colchicine may have substantial benefits in reducing myocardial infarction in selected high-risk populations but uncertainty about the size of the effect on survival and other cardiovascular outcomes is high, especially in the general population from which most of the studies in our review were drawn. Colchicine is associated with gastrointestinal side effects based on low-quality evidence. More evidence from large-scale randomised trials is needed.

PubMed Disclaimer

Conflict of interest statement

All authors declare no financial relationships with any organisation that might have an interest in the submitted work in the previous three years. Mark Nidorf was involved in one of the included studies, which was investigator‐initiated and conducted without external financial support. All other authors declare no other relationships or activities that could appear to have influenced the submitted work.

Comment in

References

References to studies included in this review

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Vuoristo 1995 {published data only}
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References to studies excluded from this review

Afdhal 2002 {published data only}
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Campollo 2001 {published data only}
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Cortez Pinto 1992 {published data only}
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De Abreu 2009 {published data only}
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Dinarello 1976 {published data only}
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Ediz 2012 {published data only}
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El‐Sherif 1999 {published data only}
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El‐Zahaar 1995 {published data only}
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English 1983 {published data only}
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Erden 2011 {published data only}
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Filipowicz‐Sosnowska 1990 {published data only}
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Fish 1997 {published data only}
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Floreani 2001 {published data only}
    1. Floreani A, Colloredo G, Lobello S, Di Marco M, Popovic A, Naccarato R. Preliminary results of a two-center trial with colchicine for the treatment of chronic hepatitis B. American Journal of Gastroenterology 2001;96(12):3451-2. - PubMed
Frayha 1979 {published data only}
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Giudice 1988 {published data only}
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Goddard 1995 {published data only}
    1. Goddard CJR, Smith A, Hunt L, Halder T, Hillier V, Rowan B, et al. Surrogate markers of response in a trial of ursodeoxycholic acid (UD A) and colchicine in primary biliary cirrhosis (PBC) [abstract]. Gut 1995;36:A30.
Goldfinger 2014 {published data only}
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Goldstein 1974 {published data only}
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Goulet 2001 {published data only}
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Grimaitre 1999 {published data only}
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Gultepe 1994 {published data only}
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Hadzic 2005 {published data only}
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Hamuryudan 2010a {published data only}
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Hamuryudan 2010b {published data only}
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Hamuryudan 2011 {published data only}
    1. Hamuryudan V, Hatemi G, Yurdakul S, Mat C, Tascilar K, Ozyazgan Y, et al. Colchicine does not decrease the need for immunosuppressive use at long term in Behcet's syndrome. Rheumatology (United Kingdom) 2011;50:ii16.
Hamuryudan 2014 {published data only}
    1. Hamuryudan V, Hatemi G, Tascilar K, Yurdakul S, Mat C, Ozyazgan Y, et al. Colchicine in Behçet syndrome: a longterm survey of patients in a controlled trial. Journal of Rheumatology 2014;41(4):735-8. - PubMed
Hatziioannidou 1992 {published data only}
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Huet 1996a {published data only}
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Huet 1996b {published data only}
    1. Huet PM, Huet J, Poupon RE, Deslauriers J. The combination of ursodeoxycholic acid (UDCA) and colchicine (C) for patients with primary biliary cirrhosis (PBC): effect on hepatic function and portal hypertension [IASL abstract]. Hepatology (Baltimore, Md.) 1996;23:I-49.
Imazio 2003 {published data only}
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Imazio 2005 {published data only}
    1. Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, et al. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation 2005;112(13):2012-6. - PubMed
Imazio 2010 {published data only}
    1. Imazio M, Trinchero R, Brucato A, Rovere ME, Gandino A, Cemin R, et al. COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS): a multicentre, randomized, double-blind, placebo-controlled trial. European Heart Journal 2010;31(22):2749-54. - PubMed
Imazio 2011a {published data only}
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Imazio 2011b {published data only}
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Imazio 2011c {published data only}
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Imazio 2011d {published data only}
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Imazio 2011e {published data only}
    1. Imazio M, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, et al. Colchicine prevents early postoperative pericardial and pleural effusions. American Heart Journal 2011;162(3):527-32.e1. - PubMed
Imazio 2012a {published data only}
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Imazio 2012b {published data only}
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Imazio 2013 {published data only}
    1. Imazio M, Brucato A, Cemin R, Ferrua S, Maggiolini S, Belli R, et al. Colchicine for acute pericarditis. Results from the Investigation on Colchicine in Acute Pericarditis (ICAP). A prospective, randomized, double-blind, placebo-controlled, multicenter trial. European Heart Journal 2013;34:167-8.
Imazio 2014a {published data only}
    1. Imazio M, Belli R, Brucato A, Cemin R, Ferrua S, Beqaraj F, et al. Efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomised trial. Lancet 2014;383:2232-7. - PubMed
Imazio 2014b {published data only}
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Iona 2014 {published data only}
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Kaplan 1985 {published data only}
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Kaplan 1987 {published data only}
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Kaplan 1993 {published data only}
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Kar 1988 {published data only}
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Karaaslan 2014 {published data only}
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Kershenobich 1979 {published data only}
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Kershenobich 1980 {published data only}
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Kisand 1996 {published data only}
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Koyuncu 2009 {published data only}
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Kulkarni 2014 {published data only}
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Kyle 1990 {published data only}
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Lenior 2001 {published data only}
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Leung 2010 {published data only}
    1. Leung J, Bonder A, Sasson M, Bonis P, Kaplan M. 19-year follow-up of patients in a double-blind trial of colchicine plus ursodiol versus methotrexate plus ursodiol in the treatment of primary biliary cirrhosis. Gastroenterology 2010;138:S218.
Leung 2011 {published data only}
    1. Leung J, Bonis PA, Kaplan MM. Colchicine or methotrexate, with ursodiol, are effective after 20 years in a subset of patients with primary biliary cirrhosis. Clinical Gastroenterology and Hepatology 2011;9(9):776-80. - PubMed
Liu 2002 {published data only}
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Lu 2014 {published data only}
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Luo 2001 {published data only}
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Maestroni 2011 {published data only}
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Maestroni 2013 {published data only}
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Maestroni 2014 {published data only}
    1. Maestroni S, Cumetti D, Valenti A, Di Corato PR, Romano M, Imazio M, et al. Efficacy and safety of colchicine in patients with multiple recurrences of pericarditis: Results of a multicenter, double-blind, placebo-controlled, randomized study (CORP-2 trial). Italian Journal of Medicine 2014;8:74-5.
Mann 2014 {published data only}
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Masuda 1989 {published data only}
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Meek 1984 {published data only}
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Meek 1985 {published data only}
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Meek 1990 {published data only}
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Miettinen 1993 {published data only}
    1. Miettinen TA, Farkkila M, Vuoristo M, Karvonen AL, Leino R, Lehtola J. Improvement of serum noncholesterol sterols may indicate retarded progression of primary biliary cirrhosis (PBC) in a randomized placebo controlled two-year trial with colchicine and urosdeoxycholic acid [abstract]. Hong Kong Medical Journal 1993;104:A954.
Miettinen 1995 {published data only}
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Mimura 2009 {published data only}
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Mingxing 1983 {published data only}
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NCT00004748 {published data only}
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Ozcelik 2014 {published data only}
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Podda 1993 {published data only}
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Poupon 1994 {published data only}
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Prieto 2003 {published data only}
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Raedsch 1991b {published data only}
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Warnes 1985 {published data only}
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Wu 1995 {published data only}
    1. Wu CS, Sun HG, Wang S. The clinic observation of colchicine for palm ane metatarsus pustule (Chinese). Chinese Journal of Dermatovenereology 1995;9:22-3.
Wu 2014 {published data only}
    1. Wu YQ, Hu JH, Zhao ZY, Zhou C, Yu X, Zheng Y, et al. Clinical observation on senile patients with acute gouty arthritis treated by acupoint application. Journal of the American Geriatrics Society 2014;62:S335–95.
Xu 1999 {published data only}
    1. Xu YM, Luo ZM, He L, Peng R, Zhou D. Clinical randomized controlled trial of patients with acute cerbral infarction treated with cyclophosphamide and colchicine. West China Medical Journal 1999;14:23-6.
Yang 2010 {published data only}
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Zemer 1974 {published data only}
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Zifroni 1991 {published data only}
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References to studies awaiting assessment

Sais 1995b {published data only}
    1. Sais G, Vidaller A, Jucglà A, Peyrí J. Treatment of cutaneous leukocytoclastic vasculitis with colchicine. Results from a prospective and randomized controlled study. Annals de Medicina 1995;81:51. - PubMed

References to ongoing studies

ACTRN12614000093684 {published data only}
    1. ACTRN12614000093684. The LoDoCo2 Trial: Low Dose Colchicine for secondary prevention of cardiovascular disease [LoDoCo2]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614000093684 (accessed 16 March 2015).
IRCT138807112539N1 {published data only}
    1. IRCT138807112539N1. A comparative evaluation of combination therapy of Lamivudine and Colchicine comparing with Lamivudine and placebo in clinical and laboratory improvement of chronic hepatitis B. www.irct.ir/searchresult.php?id=2539&number=1 (accessed 5 January 2016).
NCT01906749 {published data only}
    1. NCT01906749. Colchicine for Acute Coronary Syndromes. A multicenter double blind randomized trial [COACS]. clinicaltrials.gov/ct2/show/NCT01906749 (accessed 16 March 2015).
NCT02035891 {published data only}
    1. NCT02035891. Low-dose colchicine in patients with type 2 diabetes mellitus and microalbuminuria [CQMU-2013-QLi]. clinicaltrials.gov/ct2/show/NCT02035891 (accessed 5 January 2016).
NCT02162303 {published data only (unpublished sought but not used)}
    1. NCT02162303. A randomized, double-blind, placebo-controlled study to vvaluate the effects of colchicine on vascular inflammation as assessed with positron emission tomography (PET) imaging in patients with atherosclerotic vascular disease (COLPET). clinicaltrials.gov/ct2/show/NCT02162303 (accessed 16 March 2015).

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References to other published versions of this review

Hemkens 2014a
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