J Korean Diabetes Assoc.  2006 Nov;30(6):450-458.

Randomized, Open Label, Multicenter Clinical Trial about the Effect of Cilazapril on Vascular Endothelial Function in Patients with Type 2 Diabetes Combined with Hypertension

Affiliations
  • 1Department of Endocrinology and Metabolism, Kyung Hee University, Korea.
  • 2Department of Endocrinology and Metabolism, Korea University, Korea.
  • 3Department of Endocrinology and Metabolism, Young Nam University, Korea.
  • 4Department of Endocrinology and Metabolism, Kyung Pook National University, Korea.
  • 5Department of Endocrinology and Metabolism, Keimyung University, Korea.
  • 6Department of Endocrinology and Metabolism, Sung Kyun Kwan University, Korea.
  • 7Department of Endocrinology and Metabolism, Choong Nam National University, Korea.
  • 8Department of Endocrinology and Metabolism, Won Kwang University, Korea.
  • 9Department of Endocrinology and Metabolism, Yonsei University, Korea.

Abstract

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.

Keyword

Cilazapril; Hypertension; Type 2 Diabetes Mellitus; Vascular Endothelium

MeSH Terms

Adiponectin
Amlodipine
Atenolol
Biomarkers
Blood Pressure
Cholesterol, LDL
Cilazapril*
Diabetes Mellitus, Type 2
E-Selectin
Endothelial Cells
Endothelium, Vascular
Fibrinogen
Follow-Up Studies
Glucose
Hand
Hospitals, University
Humans
Hydrochlorothiazide
Hypertension*
Korea
Lipid Metabolism
Nitric Oxide
Oxidative Stress
Peptidyl-Dipeptidase A
Thrombophilia
Triglycerides
Adiponectin
Amlodipine
Atenolol
Cholesterol, LDL
Cilazapril
E-Selectin
Fibrinogen
Glucose
Hydrochlorothiazide
Nitric Oxide
Peptidyl-Dipeptidase A

Figure

  • Fig. 1 Summary of progression in this study.


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