Abstract
ObjectivesTo determine the anti-inflammatory effect and safety of hydroxychloroquine after acute myocardial infarction. MethodIn this multicenter, double-blind, placebo-controlled OXI trial, 125 myocardial infarction patients were randomized at a median of 43 h after hospitalization to receive hydroxychloroquine 300 mg (n = 64) or placebo (n = 61) once daily for 6 months and, followed for an average of 32 months. Laboratory values were measured at baseline, 1, 6, and 12 months. ResultsThe levels of interleukin-6 (IL-6) were comparable at baseline between study groups (p = 0.18). At six months, the IL-6 levels were lower in the hydroxychloroquine group (p = 0.042, between groups), and in the on-treatment analysis, the difference at this time point was even more pronounced (p = 0.019, respectively). The high-sensitivity C-reactive protein levels did not differ significantly between study groups at any time points. Eleven patients in the hydroxychloroquine group and four in the placebo group had adverse events leading to interruption or withdrawal of study medication, none of which was serious (p = 0.10, between groups). ConclusionsIn patients with myocardial infarction, hydroxychloroquine reduced IL-6 levels significantly more than did placebo without causing any clinically significant adverse events. A larger randomized clinical trial is warranted to prove the potential ability of hydroxychloroquine to reduce cardiovascular endpoints after myocardial infarction.
Highlights
In a retrospective study of over 1000 rheumatoid arthritis patients, the use of hydroxychloroquine was associated with a significant decrease in the risk for the composite outcome of various cardiovascular endpoints [7]
As the study was underpowered for the original primary endpoint, this study aims to assess the anti-inflammatory effect and safety of hydroxychloroquine
At the beginning of the study, acute myocardial infarction induced inflammation and elevated IL-6 levels in both study groups. Attenuation of these values was observed over time, the attenuation was steeper in the hydroxychloroquine group
Summary
Tocilizumab has shown to attenuate IL-6 response and troponin T release in non-ST-elevation myocardial infarction patients [5]. Hydroxychloroquine has been shown to lower cholesterol and glucose levels, and to possess antithrombotic properties, all of which are likely to be beneficial in the treatment of coronary artery disease [6]. In a retrospective study of over 1000 rheumatoid arthritis patients, the use of hydroxychloroquine was associated with a significant decrease in the risk for the composite outcome of various cardiovascular endpoints [7]. Long-term use of hydroxychloroquine has been associated with cardiomyopathy, neuropathy, and retinal toxicity [9]. Before large clinical trials of hydroxychloroquine for the prevention of cardiovascular events can be conducted, the anti-inflammatory effect and safety of hydroxychloroquine should be addressed in a pilot study in patients with recent myocardial infarction
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