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EDARBI (azilsartan medoxomil), Now Available in U.S. Pharmacies for Patients With Hypertension
Date:4/14/2011

ng dose of 40 mg may be appropriate for patients on high doses of diuretics. EDARBI lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone, which naturally exists within the body. When EDARBI blocks the angiotensin II receptor, blood vessels can stay relaxed and open and blood pressure can be reduced.  

Results from the phase 3 clinical trials showed EDARBI successfully met the primary endpoint, change in 24-hour mean SBP as measured by ABPM, with statistical significance of lowering blood pressure compared to placebo and head-to-head active comparators. Specifically, results from one study showed EDARBI at doses of 80 mg/day and 40 mg/day lowered 24-hour mean SBP by 14.3 mm Hg and 13.2 mm Hg from baseline, respectively. The blood pressure reductions of EDARBI (80 mg/day) were statistically superior to those of the active comparators valsartan 320 mg/day (-10.0 mm Hg) and olmesartan medoxomil 40 mg/day (-11.7 mm Hg).

Important Safety InformationBoxed Warning: Avoid Use in PregnancyWhen pregnancy is detected, discontinue EDARBI as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Avoid fetal or neonatal exposure. Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women during the second and third trimester. Nursing mothers should discontinue either nursing or EDARBI.

Correct volume or salt depletion prior to administration of EDARBI. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with EDARBI.

Monitor for worsening renal function in patients with renal impairment. In patients whose renal function may depend on the activity of the renin-angiotensin system, treatment with
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SOURCE Takeda Pharmaceuticals North America, Inc.
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