Bystolic (Nebivolol) - Summary

BYSTOLIC SUMMARY

The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1'RS)-1,1'-[(2RS,2'SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2'-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively.

Hypertension

BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ]. BYSTOLIC may be used alone or in combination with other antihypertensive agents [see Drug Interactions (7)].

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BYSTOLIC.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

See all Bystolic indications & dosage >>

NEWS HIGHLIGHTS

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Published Studies Related to Bystolic (Nebivolol)

beta-Blockers in patients with intermittent claudication and arterial hypertension: results from the nebivolol or metoprolol in arterial occlusive disease trial. [2011.08]
The use of beta-receptor blockers in peripheral arterial disease is controversial for their impact on vasomotor tone... In the direct comparison, there was no significant difference between nebivolol and metoprolol.

Effect of nebivolol vs. hydrochlorothiazide on the walking capacity in hypertensive patients with intermittent claudication. [2011.07]
CONCLUSION: The increases in ICD, ACD and ABI with nebivolol suggest that this medication does not have negative effects on hypertensive patients with symptomatic PAD, and can be used for treatment of hypertension in these patients at high cardiovascular risk without reducing the walking ability.

Comparison of antihypertensive efficacy of carvedilol and nebivolol in mild-to-moderate primary hypertension: a randomized trial. [2011.06]
OBJECTIVE: The aim of the present study is to compare the antihypertensive effects of carvedilol and nebivolol in mild-to-moderate hypertensive patients... CONCLUSION: Although both carvedilol and nebivolol effectively decreased blood pressure compared to placebo, they showed similar efficacy for lowering blood pressure.

Differential effects of nebivolol and metoprolol on central aortic pressure and left ventricular wall thickness. [2011.06]
The aim of this study was to investigate the effects of the vasodilating beta-blocker nebivolol and the cardioselective beta-blocker metoprolol succinate on aortic blood pressure and left ventricular wall thickness... This proof-of-principle study provides evidence to suggest that beta-blockers with vasodilating properties may offer advantages over conventional beta-blockers in antihypertensive therapy; however, this remains to be tested in a larger trial.

The effect of nebivolol versus metoprolol succinate extended release on asymmetric dimethylarginine in hypertension. [2011.05]
This study sought to determine if metoprolol succinate ER (MET), and nebivolol (NEB), a beta1-AR with increased bioavailability of nitric oxide (NO), would have differing effects on plasma asymmetric dimethylarginine concentration in hypertensives. It was hypothesized that NEB, a beta1-AR antagonist and beta3-AR agonist with NO-releasing properties, and MET, only a beta1-AR antagonist, would have different effects on plasma asymmetric dimethylarginine (ADMA) concentration...

more studies >>

Clinical Trials Related to Bystolic (Nebivolol)

Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life [Completed]
Beta-blockers are prescribed to millions of people for treatment of hypertension. Fatigue is a recognized and common side effect of beta-blockers that can have significant effects on quality of life. Worse, many people taking a beta-blocker for years are not even aware of the reduction of energy with which they are living. A new vasodilating beta-blocker, nebivolol, which is approved by the FDA for treatment of hypertension, appears to be far less associated with fatigue than are most currently available beta-blockers. The purpose of this study is to compare nebivolol with the current best-selling beta-blocker, metoprolol, and determine whether there is a significant difference in side effects including fatigue, reduced exertion tolerance, and reduced quality of life. In this study, 30 subjects will take each of the 2 study drugs for 8 weeks, consisting of 4 weeks at a lower dose, and 4 weeks ata higher dose. All dosages are FDA-approved for treatment of hypertension. Subjects and investigators will not know which drug is being administered until completion of the study. Subjects will undergo a treadmill stress test and will complete fatigue and quality of life questionnaires after each 4 weeks of treatment. An echocardiogram and non-invasive measurement of aortic blood pressure will be performed after 8 weeks on each drug. Also, blood will be drawn and stored for possible measurement of drug levels, after 4 and 8 weeks on each drug. Results on each drug will then be compared. If nebivolol is found to cause significantly less fatigue, it would be of substantial importance to the many millions of people who are on life-long beta-blocker therapy, and are living with reduced energy.

Comparative Effects of Nebivolol and Metoprolol on Femal Sexual Function [Recruiting]
Beta-blockers (BB) are an important treatment for high blood pressure and heart disease. However beta-blockers can cause sexual dysfunction (SD) and this common side effect limits successful use of this class of medications. Sexual side effects often result in drug discontinuation, compromising therapy goals. The investigators are conducting the study to determine if nebivolol, a newer beta blocker that is selective for receptors in the heart and causes vasodilation in the body causes fewer sexual side effects, or even improves sexual function, compared with metoprolol succinate.

Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients [Completed]
This study will investigate the blood pressure lowering efficacy of nebivolol among renal transplant recipients who are on calcineurin inhibitors which are believed to contribute to hypertension by SNS activation and decreased prostaglandin and nitric oxide production. Hypotheses: 1. Nebivolol is more beneficial than metoprolol in favorably affecting markers of oxidative stress in hypertensive renal transplant patients. 2. Nebivolol has a better impact than metoprolol on kidney function among hypertensive renal transplant patients

Effects of Nebivolol on Skeletal Muscle During Exercise in Hypertensive Patients [Recruiting]
The purpose of this study is to determine if Nebivolol improves microvascular perfusion in skeletal muscle during exercise in hypertensive patients and whether this improvement is accompanied by reduction in vascular oxidative stress or increased endothelial nitric oxide synthase (eNOS) expression in humans.

Regulatory Nebilet PMS [Completed]

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Reports of Suspected Bystolic (Nebivolol) Side Effects

Dyspnoea (18),  Fatigue (17),  Blood Pressure Increased (17),  Loss of Consciousness (15),  Palpitations (14),  Heart Rate Decreased (13),  Depression (12),  Headache (11),  Dizziness (11),  Abdominal Distension (10), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Bystolic review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		heart palpitations
Dosage & duration:		2.5mg taken 1x/day for the period of 6months
Other conditions:		none
Other drugs taken:		Loestrin-24
		Reported Results
Benefits:		I have had SVT's all my life. It was only when I turned 24 that I sought treatment for them as they usually were linked with a syncope episode. I was originally put on the grandfather of beta/alpha blockers inderal. While this drug was effective at treating my migraines, it was not particularly effective at controlling my palpitations and it tended to lower my blood pressure too much. I always felt tired and had little energy on this drug. At 24 years of age I was not happy to have the energy of a 65 year-old. Next came atenolol and labatolol (when I was pregnant). I also had break-through palpitations with these drugs as well as low-enegy side effects. With labetolol I could barely jog down my street without becoming significantly winded and according to my cardiologist I fell into the 94th percentile for "in-shape" people my age. Finally, when bystolic hit the market I was thrilled. First of all I didn't need a large dose of it to be effective. Second, it was effective. I experience no break-through palpitations, and last but not least there were very few to no side effects. I had energy again and I could get throught my cardiovascular exercise without becoming winded.
Side effects:		The beta blocker controls and regulates your heart beat so it beats on time when it's supposed to. It also however, controls your heart rate and doesn't allow it to race out of control. So when exercising, many people have a hard time being able to get their heart rate up to pump enough blood to the lungs which is why you feel winded while exercising even mildly. With Bystolic there is very little of this type of side effect. Sometimes I don't notice it at all.
Comments:		I take 2.5mg of Bystolic one time per day to control palpitations. This drug is commonly prescribed for hypertension but I do not take it for that. At this dose it does not lower my already low blood pressure very much but it is effective against the palpitations.