Drug updated on 9/5/2024
| Dosage Form | Tablet (oral; 2.5 mg, 5 mg, 10 mg, 20 mg) |
| Drug Class | Beta-adrenergic blocking agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
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Summary
- Bystolic (nebivolol) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- This summary is based on the review of five systematic reviews/meta-analyses. [1-5]
- Blood Pressure Control: Nebivolol showed mixed effectiveness in managing blood pressure. It was superior to other beta-blockers and diuretics for systolic blood pressure (SBP) control but did not significantly differ from angiotensin receptor blockers (ARBs) or calcium channel blockers. For diastolic blood pressure (DBP), nebivolol was more efficient than beta-blockers, ARBs, diuretics, and calcium channel blockers.
- Lipid Profile Improvement: Nebivolol was associated with significantly lower LDL-C levels and higher HDL-C levels compared to other beta-blockers, indicating a beneficial effect on lipid profiles.
- Endothelial Function: Nebivolol did not demonstrate a superior endothelium-protective effect compared to other beta-blockers or classes of antihypertensive drugs, suggesting its impact on endothelial function is comparable to other treatments.
- Adverse Events (AEs): Nebivolol was associated with a lower incidence of adverse events compared to other second-generation beta-blockers, and it was generally well tolerated across studies.
- Drug-Drug Interactions: Nebivolol demonstrated increased pharmacokinetic parameters (C max, AUC0-∞, and half-life) when co-administered with certain drugs like bupropion, duloxetine, and fluoxetine, indicating potential for drug-drug interactions that could lead to adverse effects.
- Subgroup Findings: Nebivolol's pharmacokinetics and effectiveness vary among specific populations: patients with chronic kidney disease (CKD) showed a three-fold increase in AUC, obese individuals experienced increased clearance, and poor metabolizers (PMs) had a 15-fold greater AUC compared to extensive metabolizers (EMs). The study population included diverse demographics, with patients aged 18-85 years, 17% of Black ethnicity, 55% men, and 10% with diabetes, highlighting its broad applicability and varying responses across these subgroups.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Bystolic (nebivolol) Prescribing Information. | 2023 | Allergan USA, Inc., Madison, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Effects of nebivolol therapy on hemodynamic parameters and lipid profile compared to other beta blockers in patients with essential hypertension: a systematic review and meta-analysis. | 2024 | Caspian Journal of Internal Medicine |
| Clinical pharmacokinetics of nebivolol: a systematic review. | 2023 | Drug Metabolism Reviews |
| Nebivolol for the treatment of essential systemic arterial hypertension: a systematic review and meta-analysis. | 2020 | American Journal of Cardiovascular Drugs |
| Efficacy and safety of nebivolol in hypertensive patients: a meta-analysis of randomized controlled trials. | 2020 | Journal of International Medical Research |
| Effects of nebivolol versus other antihypertensive drugs on the endothelial dysfunction in patients with essential hypertension. | 2020 | Bioscience Reports |