Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis.

Summary

Pilot study. The primary end point is the evaluation the efficacy of treatment with atorvastatin compared to colchicine for the decrease of high sensitivity troponin I levels in patients with rheumatoid arthritis with severe activity according of the Disease Activity Score 28 (DAS 28\> 5.1), through a randomized controlled clinical trial blinded to the rheumatologist and the cardiologist who will carry out the evaluation of the patient.

Timeline

Start

2018-08-14

Primary completion

2019-06-14

Completion

2019-06-30

Publications

• Background Smolen JS, Aletaha D, Barton A, Burmester GR, Emery P, Firestein GS, Kavanaugh A, McInnes IB, Solomon DH, Strand V, Yamamoto K. Rheumatoid arthritis. Nat Rev Dis Primers. 2018 Feb 8;4:18001. doi: 10.1038/nrdp.2018.1.
• Background Kitas G, Banks MJ, Bacon PA. Cardiac involvement in rheumatoid disease. Clin Med (Lond). 2001 Jan-Feb;1(1):18-21. doi: 10.7861/clinmedicine.1-1-18. No abstract available.
• Background Gabriel SE. Cardiovascular morbidity and mortality in rheumatoid arthritis. Am J Med. 2008 Oct;121(10 Suppl 1):S9-14. doi: 10.1016/j.amjmed.2008.06.011.
• Background Crowson CS, Liao KP, Davis JM 3rd, Solomon DH, Matteson EL, Knutson KL, Hlatky MA, Gabriel SE. Rheumatoid arthritis and cardiovascular disease. Am Heart J. 2013 Oct;166(4):622-628.e1. doi: 10.1016/j.ahj.2013.07.010. Epub 2013 Aug 29.
• Background Khalid U, Egeberg A, Ahlehoff O, Lane D, Gislason GH, Lip GYH, Hansen PR. Incident Heart Failure in Patients With Rheumatoid Arthritis: A Nationwide Cohort Study. J Am Heart Assoc. 2018 Jan 19;7(2):e007227. doi: 10.1161/JAHA.117.007227.
• Background Liao KP, Solomon DH. Traditional cardiovascular risk factors, inflammation and cardiovascular risk in rheumatoid arthritis. Rheumatology (Oxford). 2013 Jan;52(1):45-52. doi: 10.1093/rheumatology/kes243. Epub 2012 Sep 16.
• Background Prasad M, Hermann J, Gabriel SE, Weyand CM, Mulvagh S, Mankad R, Oh JK, Matteson EL, Lerman A. Cardiorheumatology: cardiac involvement in systemic rheumatic disease. Nat Rev Cardiol. 2015 Mar;12(3):168-76. doi: 10.1038/nrcardio.2014.206. Epub 2014 Dec 23.
• Background Karpouzas GA, Estis J, Rezaeian P, Todd J, Budoff MJ. High-sensitivity cardiac troponin I is a biomarker for occult coronary plaque burden and cardiovascular events in patients with rheumatoid arthritis. Rheumatology (Oxford). 2018 Jun 1;57(6):1080-1088. doi: 10.1093/rheumatology/key057.
• Background de Boer RA, Nayor M, deFilippi CR, Enserro D, Bhambhani V, Kizer JR, Blaha MJ, Brouwers FP, Cushman M, Lima JAC, Bahrami H, van der Harst P, Wang TJ, Gansevoort RT, Fox CS, Gaggin HK, Kop WJ, Liu K, Vasan RS, Psaty BM, Lee DS, Hillege HL, Bartz TM, Benjamin EJ, Chan C, Allison M, Gardin JM, Januzzi JL Jr, Shah SJ, Levy D, Herrington DM, Larson MG, van Gilst WH, Gottdiener JS, Bertoni AG, Ho JE. Association of Cardiovascular Biomarkers With Incident Heart Failure With Preserved and Reduced Ejection Fraction. JAMA Cardiol. 2018 Mar 1;3(3):215-224. doi: 10.1001/jamacardio.2017.4987.
• Background Divard G, Abbas R, Chenevier-Gobeaux C, Chanson N, Escoubet B, Chauveheid MP, Dossier A, Papo T, Dehoux M, Sacre K. High-sensitivity cardiac troponin T is a biomarker for atherosclerosis in systemic lupus erythematous patients: a cross-sectional controlled study. Arthritis Res Ther. 2017 Jun 13;19(1):132. doi: 10.1186/s13075-017-1352-7.
• Background Evans JDW, Dobbin SJH, Pettit SJ, Di Angelantonio E, Willeit P. High-Sensitivity Cardiac Troponin and New-Onset Heart Failure: A Systematic Review and Meta-Analysis of 67,063 Patients With 4,165 Incident Heart Failure Events. JACC Heart Fail. 2018 Mar;6(3):187-197. doi: 10.1016/j.jchf.2017.11.003. Epub 2018 Jan 10.
• Background Papageorgiou N, Briasoulis A, Lazaros G, Imazio M, Tousoulis D. Colchicine for prevention and treatment of cardiac diseases: A meta-analysis. Cardiovasc Ther. 2017 Feb;35(1):10-18. doi: 10.1111/1755-5922.12226.
• Background Nidorf SM, Eikelboom JW, Budgeon CA, Thompson PL. Low-dose colchicine for secondary prevention of cardiovascular disease. J Am Coll Cardiol. 2013 Jan 29;61(4):404-410. doi: 10.1016/j.jacc.2012.10.027. Epub 2012 Dec 19.
• Background Deftereos S, Giannopoulos G, Panagopoulou V, Bouras G, Raisakis K, Kossyvakis C, Karageorgiou S, Papadimitriou C, Vastaki M, Kaoukis A, Angelidis C, Pagoni S, Pyrgakis V, Alexopoulos D, Manolis AS, Stefanadis C, Cleman MW. Anti-inflammatory treatment with colchicine in stable chronic heart failure: a prospective, randomized study. JACC Heart Fail. 2014 Apr;2(2):131-7. doi: 10.1016/j.jchf.2013.11.006.
• Background Li GM, Zhao J, Li B, Zhang XF, Ma JX, Ma XL, Liu J. The anti-inflammatory effects of statins on patients with rheumatoid arthritis: A systemic review and meta-analysis of 15 randomized controlled trials. Autoimmun Rev. 2018 Mar;17(3):215-225. doi: 10.1016/j.autrev.2017.10.013. Epub 2018 Jan 31.
• Background Alvarado Cardenas M, Marin Sanchez A, Lima Ruiz J; en representacion del Grupo para estudio de Autoinmunidad y Estatinas. [Statins and autoimmunity]. Med Clin (Barc). 2015 Nov 6;145(9):399-403. doi: 10.1016/j.medcli.2014.11.017. Epub 2015 Feb 7. Spanish.
• Background Fatemi A, Moosavi M, Sayedbonakdar Z, Farajzadegan Z, Kazemi M, Smiley A. Atorvastatin effect on systemic lupus erythematosus disease activity: a double-blind randomized clinical trial. Clin Rheumatol. 2014 Sep;33(9):1273-8. doi: 10.1007/s10067-014-2654-7. Epub 2014 May 13.
• Background Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
• Background Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
• Background Friede T, Kieser M. Sample size recalculation in internal pilot study designs: a review. Biom J. 2006 Aug;48(4):537-55. doi: 10.1002/bimj.200510238.
• Background Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.

Drugs

Indications