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KMID : 0354720060300060450
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Journal of Korean Diabetes Association
2006 Volume.30 No. 6 p.450 ~ p.458
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Randomized, Open Label, Multicenter Clinical Trial about the Effect of Cilazapril on Vascular Endothelial Function in Patients with Type 2 Diabetes Combined with Hypertension
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Rhee Sang-Youl
Woo Jeong-Taek
Baik Sei-Hyun
Lee Hyung-Woo
Lee In-Kyu
Kim Hye-Sun
Lee Moon-Kyu
Shong Min-Ho
Cho Chung-Gu
Park Byoung-Hyun
Cha Bong-Soo
Kim Young-Seol
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Abstract
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Background:The angiotensin converting enzyme inhibitor (ACEi) improves the vascular endothelial cell function and has a better clinical outcome by decreasing the LDL cholesterol oxidation, hypercoagulability, oxidative stress and improving the level of endothelial nitric oxide synthesis in patients with type 2 diabetes and hypertension.
However, the correlations between the ACEi and the serum markers for the vascular endothelial function in previous studies were not consistent.
Subjects and Methods:Between July 2003 and April 2005, 104 type 2 diabetes patients
with hypertension, who had been admitted to 9 major university hospitals in Korea, were examined. The subjects were randomly allocated to the cilazapril (2.5~5 mg/day) and atenolol (50~100 mg/day) treatment group and given a combination of hydrochlorothiazide and amlodipine. The lipid profile and the markers for endothelial function, such as vWF, VCAM, E-selectin, tPA, fibrinogen, adiponectin, hsCRP, nitrotyrosine were evaluated and the differences in the variables were compared with those obtained 6 months later.
Results: A total 56 subjects completed the 6-months follow up period. Regarding the baseline characteristics, there were no significant differences in the variables observed in the two groups except for HbA1c (P = 0.037), vWF (P = 0.048), and hsCRP (P = 0.038). After 6 months, both groups showed a significant and identical decrease in the systolic and
diastolic blood pressure compared with the baseline (P < 0.002). However, there were no significant differences in the endothelial markers between each group. On the other hand, there was some deterioration in the triglyceride (P = 0.009) and HbA1c (P = 0.017) levels in the atenolol treatment groups.
Conclusions:There were no significant differences in the endothelial function markers observed between the cilazapril and atenolol groups. However, cilazapril had an identical effect on the blood pressure reduction compared with atenolol but had fewer adverse effects on the glucose and lipid metabolism.
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KEYWORD
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Cilazapril, Hypertension, Type 2 Diabetes Mellitus, Vascular Endothelium
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