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临床试验/JPRN-UMIN000002631
JPRN-UMIN000002631已完成未知

Prospective, randomized, open-label, clinical trial comparing the effects of olmesartan and amlodipine on blood pressure, endothelial function and makers for obesity/oxidative stress/chronic kidney diseases - Prospective, randomized, open-label, clinical trial comparing the effects of olmesartan and amlodipine

ational Defense Medical College0 个研究点目标入组 30 人开始时间: 2009年10月16日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
30

研究概览

简要总结

Endothelial dysfunction in essential hypertension is an independent predictor for future cardiovascular events. Although inhibition of the renin-angiotensin system (RAS) reportedly improves endothelial function through its effects on oxidative stress and inflammation, questions remain regarding which factors are pivotal for improvement of endothelial function by RAS inhibition. We therefore performed a prospective, randomized crossover trial in which an angiotensin II type 1 receptor antagonist (ARB), olmesartan, and calcium channel blocker (CCB), amlodipine, were compared in 31 essential hypertensive patients. Results showed that, although both treatments achieved comparable lowering of blood pressure (BP), olmesartan, but not amlodipine, significantly improved endothelial function as evaluated by flow-mediated vasodilation (FMD) in the brachial artery. Although no significant changes in diabetic and lipid parameters were observed with either drug, olmesartan slightly decreased estimated glomerular filtration rate which, surprisingly, translated into decreased microalbuminuria. In a similar vein, olmesartan reduced serum C-reactive protein and increased urine antioxidant levels compared to baseline, and reduced urine 8-epi-prostaglandin F2alpha levels compared to both baseline and amlodipine. Finally, although overall changes in plasma extracellular superoxide dismutase (EC-SOD) levels were not modulated by either treatment, for olmesartan there was a positive correlation between changes in FMD and those in EC-SOD levels. In conclusion, olmesartan improved endothelial function in hypertensive patients independent of its BP-lowering effect, which was due, at least in part, to its antioxidative property. Therefore, olmesartan might provide a greater long term benefit for hypertensive patients with impaired endothelial function than amlodipine.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 75years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1) Allergy against olmesartan/amlodipine 2) Poor-controlled hypertension (DBP>110 mmHg) 3) Poor-controlled diabetes (HbA1c>8.0 %) 4) Secondary hypertension 5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 6) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits. 7) End stage renal disease 8) Symptomatic (NYHA III or IV) congestive heart failure 9) Malignancies or other diseases with poor prognosis 10) Pregnant 11) Subjects whose doctor in charge do not agree to join the trial

研究者

发起方
ational Defense Medical College

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