Decrease in carotid intima media thickness after 1 year of cilostazol treatment in patients with type 2 diabetes mellitus

A multicenter exploratory study at three university hospitals was performed to evaluate the effect of Oral cilostazol on intima media thickness (IMT) in diabetic patients. A total of 141 patients was recruited in this study a nd randomized into a cilostazol group and a placebo (control) group. One hu ndred and twenty patients completed the study (i.e. 60 on cilostazol and 60 on placebo). Biochemical profiles and the IMT of the common carotid artery (CCA) determined by high-resolution B-mode ultrasonography were measured a t 0, 6, and 12 months after the oral administration of 100-200 mg of cilost azol or placebo (i.e. two or four times daily for 12 months). Clinical and biochemical characteristics. the treatment modality, and microvascular diab etic complications after randomization were not significantly different bet ween the two groups after the study. In the cilostazol treatment group, lef t CCA average IMT significantly decreased from 0.94 +/- 0.03 to 0.91 +/- 0. 02 mm at 6 months (P < 0.05). and thereafter increased to 0.92 +/- 0.01 mm (P > 0.05) at 12 months. whereas in the control group, it increased from 0. 92 +/- 0.03 to 0.93 +/- 0.01 mm at 6 months (P > 0.05). and to 0.94 +/- 0.0 1 mm at 12 months (P > 0.05). As for the light CCA average IMT, it decrease d from 0.83 +/- 0.03 to 0.82 +/- 0.01 mm at 6 months (P < 0.05). and to 0.8 1 +/- 0.01 mm at 12 months (P < 0.05) in the cilostazol group, whereas it i ncreased from 0.87 +/- 0.03 to 0.89 +/- 0.01 mm at 6 months: (P < 0.05), an d to 0.90 +/- 0.01 mm at 12 months (P < 0.05) in the control group (P < 0.0 5). After correction for risk factors such as blood pressure, smoking, and lipid profiles, there were significant changes in left and right CCA averag e IMT for both groups (P < 0.05). Left and right CCA average IMT was signif icantly different between the two groups (P < 0.05). After making statistic al corrections for blood pressure. smoking, and lipid profiles. the differe nces between these two groups remained significant (P < 0.05). Meanwhile. t here were no differences between the groups in the change of risk factors s uch as BMI. blood pressure, blood sugar, HbA(1c), and lipid profiles. Gener ally, cilostazol was well tolerated and the most common side effect in the cilostazol group was headache (12/60). mostly early in the treatment regime n. The results suggest that oral cilostazol may be helpful in the treatment of atherosclerosis in type 2 diabetic patients, although conventional card iovascular risk factors remained unmodified. (C) 2001 Elsevier Science Irel and Ltd. All rights reserved.