PMID- 31284074 OWN - NLM STAT- MEDLINE DCOM- 20200305 LR - 20200305 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 215 DP - 2019 Sep TI - The Low Dose Colchicine after Myocardial Infarction (LoDoCo-MI) study: A pilot randomized placebo controlled trial of colchicine following acute myocardial infarction. PG - 62-69 LID - S0002-8703(19)30148-6 [pii] LID - 10.1016/j.ahj.2019.06.003 [doi] AB - Following an acute myocardial infarction (MI), patients with persistently elevated biomarkers of inflammation, in particular C-reactive protein (CRP), are at significantly increased risk of further cardiovascular events. Colchicine is a unique anti-inflammatory medication that has shown promise in reducing such events in patients with stable coronary heart disease. The current study tested the ability of low dose colchicine to reduce CRP levels at 30 days after an acute MI, a key marker of future outcome, and its safety and tolerability in this setting. METHODS: We conducted a randomized, double-blind, trial of low-dose colchicine (0.5 mg daily) or matching placebo in 237 patients admitted with an acute MI. The primary end-point was the proportion of patients with a residual high sensitivity CRP level >/=2 mg/L after 30 days of treatment, a threshold associated with a worse prognosis. RESULTS: At 30-day follow-up, 44% of patients treated with colchicine had a CRP level >/=2 mg/L compared to 50% of those randomized to placebo (P = .35) and the median CRP in patients randomized to colchicine was 1.6 mg/L (interquartile range [IQR] 0.7-3.5) compared to 2.0 mg/L (IQR 0.9-4.0) in patients randomized to placebo (P = .11). The median absolute reduction in CRP levels was -4.3 mg/L (IQR -1.1 to -14.1) among colchicine treated patients and -3.3 mg/L (IQR -0.9 to -14.4, P = .44) in placebo treated patients. The relative reduction was a fall of 78% compared to a fall of 64% (P = .09). Low dose colchicine was well tolerated and did not reduce compliance with other secondary preventative medications at 30-days. CONCLUSION: Treatment with low dose colchicine was safe and well tolerated, but was not associated with a significantly increased likelihood of achieving a CRP level <2 mg/L or lower absolute levels of CRP 30 days after an acute MI. CI - Copyright (c) 2019 Elsevier Inc. All rights reserved. FAU - Hennessy, Thomas AU - Hennessy T AD - Department of Cardiology, Royal Perth Hospital, Perth and Faculty of Health and Medical Sciences, University of Western Australia; Heart Research Institute, Sydney, Department of Cardiology, Royal Prince Alfred Hospital, Sydney and Faculty of Medicine, University of Sydney. FAU - Soh, Linda AU - Soh L AD - Department of Cardiology, Royal Perth Hospital, Perth and Faculty of Health and Medical Sciences, University of Western Australia; Heart Research Institute, Sydney, Department of Cardiology, Royal Prince Alfred Hospital, Sydney and Faculty of Medicine, University of Sydney. FAU - Bowman, Mitchell AU - Bowman M AD - Department of Cardiology, Royal Perth Hospital, Perth and Faculty of Health and Medical Sciences, University of Western Australia; Heart Research Institute, Sydney, Department of Cardiology, Royal Prince Alfred Hospital, Sydney and Faculty of Medicine, University of Sydney. FAU - Kurup, Rahul AU - Kurup R AD - Department of Cardiology, Royal Perth Hospital, Perth and Faculty of Health and Medical Sciences, University of Western Australia; Heart Research Institute, Sydney, Department of Cardiology, Royal Prince Alfred Hospital, Sydney and Faculty of Medicine, University of Sydney. FAU - Schultz, Carl AU - Schultz C AD - Department of Cardiology, Royal Perth Hospital, Perth and Faculty of Health and Medical Sciences, University of Western Australia; Heart Research Institute, Sydney, Department of Cardiology, Royal Prince Alfred Hospital, Sydney and Faculty of Medicine, University of Sydney. FAU - Patel, Sanjay AU - Patel S AD - Department of Cardiology, Royal Perth Hospital, Perth and Faculty of Health and Medical Sciences, University of Western Australia; Heart Research Institute, Sydney, Department of Cardiology, Royal Prince Alfred Hospital, Sydney and Faculty of Medicine, University of Sydney. FAU - Hillis, Graham S AU - Hillis GS AD - Department of Cardiology, Royal Perth Hospital, Perth and Faculty of Health and Medical Sciences, University of Western Australia; Heart Research Institute, Sydney, Department of Cardiology, Royal Prince Alfred Hospital, Sydney and Faculty of Medicine, University of Sydney. Electronic address: graham.hillis@health.wa.gov.au. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190614 PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 RN - 0 (Biomarkers) RN - 9007-41-4 (C-Reactive Protein) RN - SML2Y3J35T (Colchicine) SB - IM MH - Biomarkers/blood MH - C-Reactive Protein/metabolism MH - Colchicine/*administration & dosage MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Female MH - Follow-Up Studies MH - Humans MH - Inflammation/blood/*drug therapy/etiology MH - Male MH - Middle Aged MH - Myocardial Infarction/blood/*complications MH - Pilot Projects MH - Retrospective Studies MH - Time Factors MH - Treatment Outcome EDAT- 2019/07/10 06:00 MHDA- 2020/03/07 06:00 CRDT- 2019/07/09 06:00 PHST- 2019/01/29 00:00 [received] PHST- 2019/06/01 00:00 [accepted] PHST- 2019/07/10 06:00 [pubmed] PHST- 2020/03/07 06:00 [medline] PHST- 2019/07/09 06:00 [entrez] AID - S0002-8703(19)30148-6 [pii] AID - 10.1016/j.ahj.2019.06.003 [doi] PST - ppublish SO - Am Heart J. 2019 Sep;215:62-69. doi: 10.1016/j.ahj.2019.06.003. Epub 2019 Jun 14.