AIMS/HYPOTHESIS: This study aimed to evaluate the effect of a phosphodiesterase inhibitor, cilostazol, on the prevention of silent brain infarction in diabetic patients without symptoms of vascular events. METHODS: A total of 89 subjects were allocated at random to the cilostazol group ( n = 43) or the control group ( n = 46). RESULTS: After the study period (3.2 +/- 0.5 years), carotid intima-media thickness (IMT) (means +/- SD) had increased ( p < 0.01) by 0.18 +/- 0.19 mm in the control group. In the cilostazol group, intima-media thickness showed almost no change (-0.00 +/- 0.16 mm). In the control group, 2 out of 46 subjects showed symptomatic brain infarctions and 10 out of 34 subjects without infarct-like region assessed by standard brain MRI examination showed silent brain infarctions after the observation period. On the other hand, no subjects in the cilostazol group showed silent brain infarction or strokes during the study period. Both at the beginning and end of the study period, the number of infarct-like regions positively correlated with IMT ( r = 0.335, p < 0.001 or r = 0.347, p < 0.001 respectively). The progression of infarct-like regions was directly related to the increase in IMT during the study period ( r = 0.299, p = 0.004). CONCLUSION/ INTERPRETATION: These data demonstrated that cilostazol could prevent the onset of silent brain infarction in Japanese subjects with Type II (non-insulin-dependent) diabetes mellitus. Also, an increase in intima-media thickness of the carotid artery wall could be able to predict the onset of silent brain infarction.
RCT Entities:
AIMS/HYPOTHESIS: This study aimed to evaluate the effect of a phosphodiesterase inhibitor, cilostazol, on the prevention of silent brain infarction in diabeticpatients without symptoms of vascular events. METHODS: A total of 89 subjects were allocated at random to the cilostazol group ( n = 43) or the control group ( n = 46). RESULTS: After the study period (3.2 +/- 0.5 years), carotid intima-media thickness (IMT) (means +/- SD) had increased ( p < 0.01) by 0.18 +/- 0.19 mm in the control group. In the cilostazol group, intima-media thickness showed almost no change (-0.00 +/- 0.16 mm). In the control group, 2 out of 46 subjects showed symptomatic brain infarctions and 10 out of 34 subjects without infarct-like region assessed by standard brain MRI examination showed silent brain infarctions after the observation period. On the other hand, no subjects in the cilostazol group showed silent brain infarction or strokes during the study period. Both at the beginning and end of the study period, the number of infarct-like regions positively correlated with IMT ( r = 0.335, p < 0.001 or r = 0.347, p < 0.001 respectively). The progression of infarct-like regions was directly related to the increase in IMT during the study period ( r = 0.299, p = 0.004). CONCLUSION/ INTERPRETATION: These data demonstrated that cilostazol could prevent the onset of silent brain infarction in Japanese subjects with Type II (non-insulin-dependent) diabetes mellitus. Also, an increase in intima-media thickness of the carotid artery wall could be able to predict the onset of silent brain infarction.