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

Not Applicable

• Conditions: Hypertension

• Registration Number: JPRN-UMIN000002631
• Lead Sponsor: ational Defense Medical College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-16
• Study Completion: 2011-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure (On visit/Home monitoring) Flow-mediated vasodilation in forearm Heparin-releasable EC-SOD levels Twelve weeks after administration

Secondary Outcome Measures

Name	Time	Method
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria) Twelve weeks after administration