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| _NOTOC__
| | #REDIRECT [[Nebivolol#Clinical Studies]] |
| {{Nebivolol}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Clinical Studies==
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| ===[[hypertension]]===
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| The antihypertensive effectiveness of BYSTOLIC as monotherapy has been demonstrated in three randomized, double-blind, multi-center, placebo-controlled trials at doses ranging from 1.25 to 40 mg for 12 weeks (Studies 1, 2, and 3). A fourth placebo-controlled trial demonstrated additional antihypertensive effects of BYSTOLIC at doses ranging from 5 to 20 mg when administered concomitantly with up to two other antihypertensive agents (ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics) in patients with inadequate blood pressure control.
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| The three monotherapy trials included a total of 2016 patients (1811 BYSTOLIC, 205 placebo) with mild to moderate [[hypertension]] who had baseline diastolic blood pressures (DBP) of 95 to 109 mmHg. Patients received either BYSTOLIC or placebo once daily for twelve weeks. Two of these monotherapy trials (Studies 1 and 2) studied 1716 patients in the general hypertensive population with a mean age of 54 years, 55% males, 26% non-Caucasians, 7% diabetics and 6% genotyped as PMs. The third monotherapy trial (Study 3) studied 300 Black patients with a mean age of 51 years, 45% males, 14% diabetics, and 3% as PMs.
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| Placebo-subtracted blood pressure reductions by dose for each study are presented in Table 2. Most studies showed increasing response to doses above 5 mg.
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| Study 4 enrolled 669 patients with a mean age of 54 years, 55% males, 54% Caucasians, 29% Blacks, 15% Hispanics, 1% Asians, 14% diabetics, and 5% PMs. BYSTOLIC, 5 mg to 20 mg, administered once daily concomitantly with stable doses of up to two other antihypertensive agents (ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics) resulted in significant additional antihypertensive effects over placebo compared to baseline blood pressure.
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| Effectiveness was similar in subgroups analyzed by age and sex. Effectiveness was established in Blacks, but as monotherapy the magnitude of effect was somewhat less than in Caucasians.
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| The blood pressure lowering effect of BYSTOLIC was seen within two weeks of treatment and was maintained over the 24-hour dosing interval.
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| There are no trials of BYSTOLIC demonstrating reductions in cardiovascular risk in patients with [[hypertension]], but at least one pharmacologically similar drug has demonstrated such benefits.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8 | publisher = | date = | accessdate = 4 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Beta blockers]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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