Abstract
Background: Statin treatment results in a reduction in cardiovascular mortality. Here we test the hypothesis in a double-blinded multi-center randomized trial using fluorodeoxyglucose positron emission tomography imaging (FDG-PET), that high dose statins results in further reduction in plaque inflammation compared to low dose statins. Methods: Adults with risk factors for or established atherosclerosis, who were not already on high-dose statin (n= 83, median age 59 yrs, range 37-78 yrs, 78% men), were randomized (1:1) to 10 vs. 80mg of atorvastatin. FDG-PET imaging was performed before and 12 wks after randomization to measure atherosclerotic inflammation in the aorta and carotids. Arterial wall FDG uptake (target) was normalized to blood pool (background), yielding a target to background ratio (TBR). The most diseased segment (MDS) was defined as the 1.5 cm segment that included the highest TBR at baseline. All analyses were performed while blinded to time points and treatment. Results: Sixty-seven individuals completed the protocol and provided data for analysis. At 12 wks, inflammation (TBR) in the MDS was significantly reduced in atorva 10mg (% reduction from baseline [90% CI], 6.3 [1.2,11.2], 2-sided p< 0.05, fig A), as well as atorva 80mg groups (14.6 [9.7, 19.2], p<0.001). Moreover, atorva 80 resulted in a significant additional reduction in TBR relative to atorva 10 (%relative additional reduction= 8.8 [1.6, 15.6], p<0.05). Further, a reduction in TBR was seen in patients randomized to atorva 80 who were already on a low-dose statin at baseline, (13.5 [6.9, 19.6], p=0.002, fig B). Changes in TBR did not correlate with changes in lipids. Conclusions: We observe a dose-related reduction in atherosclerotic inflammation in this first multi-center double-blinded trial evaluating effect of statins on FDG-PET measures of atherosclerotic inflammation. FDG-PET imaging may provide a useful assessment of treatment effect in patients already taking statins.
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