Effect of cilostazol on carotid plaque volume measured by three‐dimensional ultrasonography in patients with type 2 diabetes: The FANCY study

Aims To conduct a prospective randomized study to evaluate cilostazol, a phosphodiesterase 3 inhibitor, and compare it with aspirin for the prevention of the progression of atherosclerosis in patients with type 2 diabetes (T2D). Materials and methods Fifty patients with T2D and carotid atherosclerotic plaques were randomly assigned to either a 200 mg/d cilostazol (CTZ) group or a 100 mg/d aspirin (ASA) group for 6 months. The primary endpoint was change in plaque volume measured by carotid three‐dimensional ultrasonography. The secondary endpoints were changes in carotid intima–media thickness (IMT) and endothelial function, assessed by laser Doppler. Results Twenty‐four patients in the CTZ group and 23 in the ASA group were included in the final analysis. The mean ± SD age of male (n = 20) and female (n = 16) patients was 62.2 and 59.1 years, respectively. The total plaque volume was slightly decreased in the CTZ group (from 183.8 ± 52.5 to 181.5 ± 54.0 mm 3 ; P = .567), but significantly increased in the ASA group (from 112.9 ± 21.2 to 128.5 ± 23.3 mm 3 ; P = .043). A significant regression in the maximum IMT was observed only in the CTZ group (right: from 2.19 ± 0.17 to 1.96 ± 0.12 mm; left: from 2.02 ± 0.20 to 1.72 ± 0.19 mm). The CTZ group exhibited an increase in HDL cholesterol and a decrease in triglycerides and liver enzymes. Conclusions Cilostazol treatment for 6 months significantly attenuated the progression of carotid plaque compared with aspirin in patients with T2D (NCT03248401).