Thomas Hennessy1, Linda Soh1, Mitchell Bowman1, Rahul Kurup1, Carl Schultz1, Sanjay Patel1, Graham S Hillis2. 1. 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. 2. 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.
Abstract
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.
RCT Entities:
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.
Authors: Yao Neng Teo; Yao Hao Teo; Nicholas L Syn; Ming Wei Goh; Celine Shuen Yin Yoong; Chi-Hang Lee; Mark Yan-Yee Chan; Ping Chai; Tiong-Cheng Yeo; Ching-Hui Sia Journal: High Blood Press Cardiovasc Prev Date: 2021-05-18
Authors: Spyridon G Deftereos; Frans J Beerkens; Binita Shah; George Giannopoulos; Dimitrios A Vrachatis; Sotiria G Giotaki; Gerasimos Siasos; Johny Nicolas; Clare Arnott; Sanjay Patel; Mark Parsons; Jean-Claude Tardif; Jason C Kovacic; George D Dangas Journal: Circulation Date: 2021-12-29 Impact factor: 29.690
Authors: Allison G Hays; Michael Schär; Patricia Barditch-Crovo; Shashwatee Bagchi; Gabriele Bonanno; Joseph Meyer; Yohannes Afework; Valerie Streeb; Samuel Stradley; Shannon Kelly; Nicole M Anders; Joseph B Margolick; Shenghan Lai; Gary Gerstenblith; Robert G Weiss Journal: AIDS Date: 2021-06-01 Impact factor: 4.632