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VIOS Study Results
The arteriolar dimensions (W/L Ratios) in the olmesartan medoxomil and atenolol-based treatment groups were similar prior to drug treatment (14.9% and 16% respectively) whereas arteries from the normotensive subjects had significantly smaller W/L ratios (11%). At the end of the study the W/L ratio in the olmesartan medoxomil-based treatment group was significantly reduced (from 14.9% to a mean of 11.1%, P
This study was supported through an unrestricted grant from Daiichi Sankyo, Inc.
Ongoing Studies with Olmesartan Medoxomil
Olmestartan medoxomil is currently being reviewed in several outcomes trials, including the landmark "Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention Study" or ROADMAP trial. This is a Phase IV multinational clinical study to investigate the drug's effectiveness in preventing early stage kidney disease in patients with Type 2 diabetes. The trial is being conducted at 200 sites in 20 countries involving 4,400 patients. Another study, titled "Olmesartan Reducing Incidence of End stage renal stage in diabetic Nephropathy Trial," or ORIENT, targeting Japanese and Hong Kong Chinese patients, is investigating the suppressive effects of the drug against the progression of diabetic nephropathy.
About Benicar and Benicar HCT
Angiotensin II is a hormone that interacts with a receptor on arterial blood vessels, which results in constriction and increasing blood pressure. In addition, angiotensin II stimulates the release of another hormone that causes enhanced sodium and chloride (salt) retention, with a resultant increase in vascular water retention and blood volume that also contributes to an elevation in blood pressure. BENICAR is a member of the ARB class of antihypertensive medications that help lower blood pressure by blocking the angiotensin II receptor on the blood vessels and antagonizing the release of the hormone which causes salt retention and increased blood volume. BENICAR HCT combines BENICAR with the diuretic hydrochlorothiazide.
BENICAR and BENICAR HCT are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. BENICAR HCT is not indicated for initial therapy.
Important Safety Information
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, BENICAR or BENICAR HCT should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality in the prescribing information.
Hypotension in Volume- or Salt-Depleted Patients
In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (eg, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with BENICAR. Treatment should start under close medical supervision. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
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