Skip to main content
Erschienen in: Drugs 12/2010

01.08.2010 | Adis Drug Profile

Oral Colchicine (Colcrys®)

In the Treatment and Prophylaxis of Gout

verfasst von: Lily P. H. Yang

Erschienen in: Drugs | Ausgabe 12/2010

Einloggen, um Zugang zu erhalten

Abstract

Oral colchicine (Colcrys®) is approved in the US for the treatment of acute gout flares in adult patients and the prophylaxis of gout flares in patients aged >16 years.
Colchicine is a tricyclic alkaloid that interrupts multiple inflammatory response pathways. Its principal mechanism of action in gout is thought to be inhibition of cytoskeletal microtubule polymerization, an important process in neutrophil functioning.
In a phase III, randomized, double-blind, placebo-controlled, multicentre trial, the recommended dosage of Colcrys® (1.2 mg at the first sign of the flare, followed by 0.6 mg in 1 hour) was significantly more effective than placebo in treating acute gout flare, as assessed by the proportion of patients experiencing a ≥50% reduction in pain within 24 hours of initiating treatment.
In a randomized, double-blind, placebo-controlled, single-centre trial, non-approved colchicine 0.6 mg once or twice daily (up to 6 months) was more effective than placebo in preventing gout flares in patients receiving allopurinol as urate-lowering therapy.
At the recommended dosage for the treatment of acute gout flares, Colcrys® was as well tolerated as placebo in patients with gout. The incidence of the most common adverse events was similar between recipients of the recommended dosage of Colcrys® and placebo.
Literatur
2.
Zurück zum Zitat Dalbeth N, Haskard DO. Mechanisms of inflammation in gout. Rheumatol 2005 Sep; 44(9): 1090–6CrossRef Dalbeth N, Haskard DO. Mechanisms of inflammation in gout. Rheumatol 2005 Sep; 44(9): 1090–6CrossRef
3.
Zurück zum Zitat Nuki G. Colchicine: its mechanism of action and efficacy in crystal-induced inflammation. Curr Rheumatol Rep 2008 Jul; 10(3): 218–27CrossRefPubMed Nuki G. Colchicine: its mechanism of action and efficacy in crystal-induced inflammation. Curr Rheumatol Rep 2008 Jul; 10(3): 218–27CrossRefPubMed
4.
Zurück zum Zitat Schumacher Jr HR, Edwards LN, Perez-Ruiz F, et al. Outcome measures for acute and chronic gout. OMERACT 7 Special Interest Group. J Rheumatol 2005 Dec; 32(12): 2452–5PubMed Schumacher Jr HR, Edwards LN, Perez-Ruiz F, et al. Outcome measures for acute and chronic gout. OMERACT 7 Special Interest Group. J Rheumatol 2005 Dec; 32(12): 2452–5PubMed
5.
Zurück zum Zitat Teng GG, Nair R, Saag KG. Pathophysiology, clinical presentation and treatment of gout. Drugs 2006; 66(12): 1547–63CrossRefPubMed Teng GG, Nair R, Saag KG. Pathophysiology, clinical presentation and treatment of gout. Drugs 2006; 66(12): 1547–63CrossRefPubMed
6.
Zurück zum Zitat Terkeltaub R, Zelman D, Scavulli J, et al. Gout Study Group: update on hyperuricemia and gout. Joint Bone Spine 2009 Jul; 76(4): 444–6CrossRefPubMed Terkeltaub R, Zelman D, Scavulli J, et al. Gout Study Group: update on hyperuricemia and gout. Joint Bone Spine 2009 Jul; 76(4): 444–6CrossRefPubMed
7.
Zurück zum Zitat Doherty M. New insights into the epidemiology of gout. Rheumatology (Oxford) 2009 May; 48 Suppl. 2: ii2–8 Doherty M. New insights into the epidemiology of gout. Rheumatology (Oxford) 2009 May; 48 Suppl. 2: ii2–8
9.
Zurück zum Zitat Bhole V, de Vera M, Rahman MM, et al. Epidemiology of gout in women: fifty-two-year followup of a prospective cohort. Arthritis Rheum 2010 Apr; 62(4): 1069–76CrossRefPubMed Bhole V, de Vera M, Rahman MM, et al. Epidemiology of gout in women: fifty-two-year followup of a prospective cohort. Arthritis Rheum 2010 Apr; 62(4): 1069–76CrossRefPubMed
10.
Zurück zum Zitat Zhang W, Doherty M, Bardin T, et al. EULAR evidence based recommendations for gout. Part II: management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2006 Oct; 65(10): 1312–24PubMedPubMedCentral Zhang W, Doherty M, Bardin T, et al. EULAR evidence based recommendations for gout. Part II: management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2006 Oct; 65(10): 1312–24PubMedPubMedCentral
11.
Zurück zum Zitat Schumacker HR, Taylor W, Edwards L, et al. Outcome domains for studies of acute and chronic gout. J Rheumatol 2009 Oct; 36(10): 2342–5CrossRef Schumacker HR, Taylor W, Edwards L, et al. Outcome domains for studies of acute and chronic gout. J Rheumatol 2009 Oct; 36(10): 2342–5CrossRef
12.
Zurück zum Zitat Schlesinger N. Overview of the management of acute gout and the role of adrenocorticotropic hormone. Drugs 2008; 68(4): 407–15CrossRefPubMed Schlesinger N. Overview of the management of acute gout and the role of adrenocorticotropic hormone. Drugs 2008; 68(4): 407–15CrossRefPubMed
13.
Zurück zum Zitat Jordan KM, Cameron JS, Snaith M, et al. British Society for Rheumatology and British Health Professionals in Rheumatology guideline for the management of gout. British Society for Rheumatology and British Health Professionals in Rheumatology Standards, Guidelines and Audit Working Group (SGAWG). Rheumatology (Oxford) 2007 Aug; 46(8): 1372–4 Jordan KM, Cameron JS, Snaith M, et al. British Society for Rheumatology and British Health Professionals in Rheumatology guideline for the management of gout. British Society for Rheumatology and British Health Professionals in Rheumatology Standards, Guidelines and Audit Working Group (SGAWG). Rheumatology (Oxford) 2007 Aug; 46(8): 1372–4
14.
Zurück zum Zitat Schlesinger N, Schumacher R, Catton M, et al. Colchicine for acute gout. Cochrane Database Syst Rev 2006 Oct 18; (4): CD006190 Schlesinger N, Schumacher R, Catton M, et al. Colchicine for acute gout. Cochrane Database Syst Rev 2006 Oct 18; (4): CD006190
15.
Zurück zum Zitat Finkelstein Y, Aks SE, Hutson JR, et al. Colchicine poisoning: the dark side of an ancient drug. Clin Toxicol (Phila) 2010 Jun; 48(5): 407–14CrossRef Finkelstein Y, Aks SE, Hutson JR, et al. Colchicine poisoning: the dark side of an ancient drug. Clin Toxicol (Phila) 2010 Jun; 48(5): 407–14CrossRef
16.
Zurück zum Zitat Sutaria S, Katbamna R, Underwood M. Effectiveness of interventions for the treatment of acute and prevention of recurrent gout: a systematic review. Rheumatology (Oxford) 2006 Nov; 45(11): 1422–31CrossRef Sutaria S, Katbamna R, Underwood M. Effectiveness of interventions for the treatment of acute and prevention of recurrent gout: a systematic review. Rheumatology (Oxford) 2006 Nov; 45(11): 1422–31CrossRef
17.
Zurück zum Zitat Perez-Ruiz F. Treating to target: a strategy to cure gout. Rhuematology (Oxford) 2009 May; 48 Suppl. 2: ii9–14 Perez-Ruiz F. Treating to target: a strategy to cure gout. Rhuematology (Oxford) 2009 May; 48 Suppl. 2: ii9–14
18.
Zurück zum Zitat Terkeltaub R. Update on gout: new therapeutic strategies and options. Nat Rev Rheumatol 2010 Jan; 6(1): 30–8CrossRefPubMed Terkeltaub R. Update on gout: new therapeutic strategies and options. Nat Rev Rheumatol 2010 Jan; 6(1): 30–8CrossRefPubMed
19.
20.
Zurück zum Zitat Bhat A, Naguwa SM, Cheema GS, et al. Colchicine revisited. Ann N Y Acad Sci 2009 Sep; 1173: 766–73CrossRefPubMed Bhat A, Naguwa SM, Cheema GS, et al. Colchicine revisited. Ann N Y Acad Sci 2009 Sep; 1173: 766–73CrossRefPubMed
21.
22.
Zurück zum Zitat Sundy JS. Progress in the pharmacotherapy of gout. Curr Opin Rheumatol 2010 Mar; 22(2): 188–93CrossRefPubMed Sundy JS. Progress in the pharmacotherapy of gout. Curr Opin Rheumatol 2010 Mar; 22(2): 188–93CrossRefPubMed
26.
Zurück zum Zitat Kesselheim AS, Solomon DH. Incentives for drug development: the curious case of colchicine. N Engl J Med 2010 Jun 3; 362(22): 2045–7CrossRefPubMed Kesselheim AS, Solomon DH. Incentives for drug development: the curious case of colchicine. N Engl J Med 2010 Jun 3; 362(22): 2045–7CrossRefPubMed
29.
Zurück zum Zitat Ravelli RBG, Gigant B, Curmi PA, et al. Insight into tubulin regulation from a complex with colchicine and a stathmin-like domain. Nature 2004 Mar 11; 428(6979): 198–202CrossRefPubMed Ravelli RBG, Gigant B, Curmi PA, et al. Insight into tubulin regulation from a complex with colchicine and a stathmin-like domain. Nature 2004 Mar 11; 428(6979): 198–202CrossRefPubMed
30.
Zurück zum Zitat Pascual E, Castellano JA. Treatment with colchicine decreases white cell counts in synovial fluid of asymptomatic knees that contain monosodium urate crystals. J Rheumatol 1992 Apr; 19(4): 600–3PubMed Pascual E, Castellano JA. Treatment with colchicine decreases white cell counts in synovial fluid of asymptomatic knees that contain monosodium urate crystals. J Rheumatol 1992 Apr; 19(4): 600–3PubMed
31.
Zurück zum Zitat Terkeltaub RA, Furst DE, Bennett K, et al. High vs low dosing of oral colchicine for early acute gout flare: twenty-four hour outcome results of the first randomized, placebo-controlled, dose comparison colchicine trial. Arthritis Rheum 2010 Apr; 62(4): 1060–8CrossRefPubMed Terkeltaub RA, Furst DE, Bennett K, et al. High vs low dosing of oral colchicine for early acute gout flare: twenty-four hour outcome results of the first randomized, placebo-controlled, dose comparison colchicine trial. Arthritis Rheum 2010 Apr; 62(4): 1060–8CrossRefPubMed
32.
Zurück zum Zitat Chappey ON, Niel E, Wautier J-L, et al. Colchicine disposition in human leukocytes after single and multiple oral administration. Clin Pharmacol Ther 1993 Oct; 54(4): 360–7CrossRefPubMed Chappey ON, Niel E, Wautier J-L, et al. Colchicine disposition in human leukocytes after single and multiple oral administration. Clin Pharmacol Ther 1993 Oct; 54(4): 360–7CrossRefPubMed
33.
Zurück zum Zitat Borstad GC, Bryant LR, Abel MP, et al. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol 2004 Dec; 31(12): 2429–32PubMed Borstad GC, Bryant LR, Abel MP, et al. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol 2004 Dec; 31(12): 2429–32PubMed
34.
Zurück zum Zitat Becker MA, Schumacher Jr HR, Wortmann RL, et al. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum 2005 Mar; 52(3): 916–23CrossRefPubMed Becker MA, Schumacher Jr HR, Wortmann RL, et al. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum 2005 Mar; 52(3): 916–23CrossRefPubMed
35.
Zurück zum Zitat Becker MA, Schumacher Jr HR, Wortmann RL, et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med 2005 Dec 8; 353(23): 2450–61CrossRefPubMed Becker MA, Schumacher Jr HR, Wortmann RL, et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med 2005 Dec 8; 353(23): 2450–61CrossRefPubMed
36.
Zurück zum Zitat Becker MA, Schumacher HR, Espinoza LR, et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther 2010 Apr 6; 12(2): R63CrossRefPubMedPubMedCentral Becker MA, Schumacher HR, Espinoza LR, et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther 2010 Apr 6; 12(2): R63CrossRefPubMedPubMedCentral
37.
Zurück zum Zitat Ahern MJ, Reid C, Gordon TP. Does colchicine work? The results of the first controlled study in acute gout. Aust N Z J Med 1987 Jun; 17(3): 301–4CrossRefPubMed Ahern MJ, Reid C, Gordon TP. Does colchicine work? The results of the first controlled study in acute gout. Aust N Z J Med 1987 Jun; 17(3): 301–4CrossRefPubMed
38.
Zurück zum Zitat AR Scientific, Inc. A multicenter, randomized, double-blind, placebo-controlled, parallel group, 1-week, dose-comparison study to evaluate the efficacy, safety, and tolerability of colchicine in subjects with an acute gout flare. Philadelphia (PA): AR Scientific, Inc., 2008 Sep 23. Report no. MPC-004-06-001 AR Scientific, Inc. A multicenter, randomized, double-blind, placebo-controlled, parallel group, 1-week, dose-comparison study to evaluate the efficacy, safety, and tolerability of colchicine in subjects with an acute gout flare. Philadelphia (PA): AR Scientific, Inc., 2008 Sep 23. Report no. MPC-004-06-001
39.
Zurück zum Zitat Terkeltaub R, Furst DE, Bennett K, et al. Colchicine efficacy assessed by time to 50% reduction of pain is comparable in low dose and high dose regimens: secondary analyses of the AGREE trial [abstract no. 1103]. 73rd Annual Meeting of the American College of Rheumatology and the 44th Annual Meeting of the Association of Rheumatology Health Professionals; 2009 Oct 16–21; Philadelphia (PA) Terkeltaub R, Furst DE, Bennett K, et al. Colchicine efficacy assessed by time to 50% reduction of pain is comparable in low dose and high dose regimens: secondary analyses of the AGREE trial [abstract no. 1103]. 73rd Annual Meeting of the American College of Rheumatology and the 44th Annual Meeting of the Association of Rheumatology Health Professionals; 2009 Oct 16–21; Philadelphia (PA)
Metadaten
Titel
Oral Colchicine (Colcrys®)
In the Treatment and Prophylaxis of Gout
verfasst von
Lily P. H. Yang
Publikationsdatum
01.08.2010
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 12/2010
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.2165/11205470-000000000-00000

Weitere Artikel der Ausgabe 12/2010

Drugs 12/2010 Zur Ausgabe

Adis Drug Evaluation

Glatiramer Acetate

Adis Drug Profile

Oral Bepotastine

Therapy in Practice

Laxative Abuse