Abstract
Clinical trials demonstrated that a fixed-dose combination (FDC) of the beta-blocker nebivolol (5 mg) and the angiotensin II antagonist valsartan (80 mg) produced a significant reduction of both diastolic and systolic blood pressure in patients with hypertension. Both nebivolol and valsartan contributed to this effect, partial additivity of 86.6% and 82.2% being observed for diastolic and systolic blood pressure, respectively. These values are very similar to the additivity ratios of other recently approved FDCs for hypertension. Use of the FDC nebivolol 5 mg/valsartan 80 mg formulation was associated with a low incidence of treatment-related adverse effects and of serious adverse effects. There was no evidence of adverse effects due to beta2-adrenoceptor blockade. The FDC (Byvalson) was approved and launched in 2016 in the U.S. for the treatment of hypertension.
Keywords:
Fixed-dose combination; Hypertension; Nebivolol; Valsartan.
Copyright 2017 Clarivate Analytics.
MeSH terms
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Adrenergic beta-1 Receptor Agonists / administration & dosage*
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Adrenergic beta-1 Receptor Agonists / adverse effects
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Adrenergic beta-1 Receptor Agonists / pharmacokinetics
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Angiotensin II Type 1 Receptor Blockers / administration & dosage*
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Angiotensin II Type 1 Receptor Blockers / adverse effects
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Angiotensin II Type 1 Receptor Blockers / pharmacokinetics
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Antihypertensive Agents / administration & dosage*
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Antihypertensive Agents / adverse effects
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Antihypertensive Agents / pharmacokinetics
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Blood Pressure / drug effects*
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Drug Approval
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Drug Combinations
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Humans
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Hypertension / diagnosis
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Hypertension / drug therapy*
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Hypertension / physiopathology
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Nebivolol / administration & dosage*
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Nebivolol / adverse effects
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Nebivolol / pharmacokinetics
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Treatment Outcome
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United States
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United States Food and Drug Administration
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Valsartan / administration & dosage*
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Valsartan / adverse effects
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Valsartan / pharmacokinetics
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Vasodilator Agents / administration & dosage*
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Vasodilator Agents / adverse effects
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Vasodilator Agents / pharmacokinetics
Substances
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Adrenergic beta-1 Receptor Agonists
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Angiotensin II Type 1 Receptor Blockers
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Antihypertensive Agents
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Drug Combinations
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Vasodilator Agents
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Nebivolol
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Valsartan