Nebivolol: In the treatment of hypertension in the US

American Journal of Cardiovascular Drugs

Volumn 9, Issue 4, 2009, Pages 253-260

  Baldwin, Claudine M ^a   Keam, Susan J ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; BETAXOLOL; BISOPROLOL; BUCINDOLOL; BYSTOLIC; CARVEDILOL; CELIPROLOL; CIMETIDINE; DIURETIC AGENT; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; METOPROLOL; NEBIVOLOL; NITROGEN; PLACEBO; PROPRANOLOL; SILDENAFIL; TRIACYLGLYCEROL; UNCLASSIFIED DRUG; UREA;

ANTIHYPERTENSIVE ACTIVITY; ANTIHYPERTENSIVE THERAPY; BRADYCARDIA; CARDIOGENIC SHOCK; CLINICAL TRIAL; DEPRESSION; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DRUG CONTRAINDICATION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INFORMATION; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ENDOTHELIAL DYSFUNCTION; ERECTILE DYSFUNCTION; FATIGUE; HEADACHE; HEART BLOCK; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART STROKE VOLUME; HUMAN; HYPERTENSION; IN VITRO STUDY; LIVER FAILURE; MONOTHERAPY; ORTHOSTATIC HYPOTENSION; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; SICK SINUS SYNDROME; SIDE EFFECT; SINGLE DRUG DOSE; THROMBOCYTE COUNT; TREATMENT RESPONSE; TRIACYLGLYCEROL BLOOD LEVEL; UREA NITROGEN BLOOD LEVEL; URIC ACID BLOOD LEVEL;

ADRENERGIC BETA-ANTAGONISTS; ANTIHYPERTENSIVE AGENTS; BENZOPYRANS; BLOOD PRESSURE; DRUG ADMINISTRATION SCHEDULE; ETHANOLAMINES; HUMANS; HYPERTENSION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES;

EID: 70349116062     PISSN: 11753277     EISSN: 1179187X     Source Type: Journal    
DOI: 10.2165/1120274-000000000-00000     Document Type: Review

References (43)

1. Roberts WC, Black HR, Bakris GL, et al. The editor's roundtable: revisiting the role of b-blockers in hypertension. Am J Cardiol 2007 Jul 15; 100 (2): 253-267
2. Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003 Dec; 42 (6): 1206-1252
3. AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus: hypertension management. Endocr Pract 2007; 13 Suppl. 1: 35-40
4. A.Menarini Pharma U.K. S.R.L. Nebilet 5 mg tablets: summary of product characteristics [online]. Available from URL: http://emc.medicines.org.uk/ medicine/9145/SPC/Nebilet%205mg%20Tablets/[Accessed 2009 Mar 11]
5. Forest Laboratories Inc. Bystolic® (nebivolol) tablets 2.5 mg, 5 mg, 10 mg and 20 mg: US prescribing information [online]. Available from URL: http:// www.frx.com/pi/bystolic-pi.pdf [Accessed 2009 Mar 5]
6. Forest Laboratories Inc. Forest Laboratories, Inc. announces amendment to Bystolic® (nebivolol) agreement [media release: 2008 Feb 27; online]. Available from URL: http://www.frx.com/news/PressRelease.aspx?ID=1113275 [Accessed 2009 Jul 3]
7. McNeely W, Goa KL. Nebivolol in the management of essential hypertension: a review. Drugs 1999 Apr; 57 (4): 633-651
8. Moen MD, Wagstaff AJ. Nebivolol: a review of its use in the management of hypertension and chronic heart failure. Drugs 2006; 66 (10): 1389-1409
9. Himmelmann A, Hedner T, Snoeck E, et al. Haemodynamic effects and pharmacokinetics of oral d-and l-nebivolol in hypertensive patients. Eur J Clin Pharmacol 1996; 51 (3-4): 259-264
10. Zanchetti A. Clinical pharmacodynamics of nebivolol: new evidence of nitric oxide-mediated vasodilating activity and peculiar haemodynamic properties in hypertensive patients. Blood Press Suppl 2004 Oct; 13 Suppl. 1: 17-32
11. Van de Water A, Janssens W, Van Neuten J, et al. Pharmacological and hemodynamic profile of nebivolol, a chemically novel, potent, and selective b1-adrenergic antagonist. J Cardiovasc Pharmacol 1988; 11 (5): 552-563
12. Bristow MR, Nelson P, Winobe W, et al. Characterization of b1-adrenergic receptor selectivity of nebivolol and various other b-blockers in human myocardium [abstract no. P-121]. Am J Hypertens 2005; 18 (5 Pt 2): 51-52
13. Mason RP. Nitric oxide mechanisms in the pathogenesis of global risk. J Clin Hypertens (Greenwich) 2006 Aug; 8 (8 Suppl. 2): 31-38
14. Gupta S, Wright HM. Nebivolol: a highly selective b1-adrenergic receptor blocker that causes vasodilation by increasing nitric oxide. Cardiovasc Ther 2008; 26 (3): 189-202
15. Hillebrand U, Lang D, Telgmann RG, et al. Nebivolol decreases endothelial cell stiffness via the estrogen receptor-b: a nano-imaging study. J Hypertens 2009; 27: 517-526
16. Ignarro LJ. Experimental evidences of nitric oxide-dependent vasodilatory activity of nebivolol, a third-generation b-blocker. Blood Press Suppl 2004 Oct; 13 Suppl. 1: 2-16
17. Ignarro LJ. Different pharmacological properties of two enantiomers in a unique b-blocker, nebivolol. Cardiovasc Ther 2008; 26: 115-134
18. Brett SE, Forte P, Chowienczyk PJ, et al. Comparison of the effects of nebivolol and bisoprolol on systemic vascular resistance in patients with essential hypertension: b-blockade and haemodynamics in hypertension. Clin Drug Investig 2002; 22 (6): 355-359
19. Tzemos N, Lim PO, MacDonald TM. Nebivolol reverses endothelial dysfunction in essential hypertension: a randomized, double-blind, crossover study. Circulation 2001; 104 (5): 511-514
20. Mahmud A, Feely J. b-Blockers reduce aortic stiffness in hypertension but nebivolol, not atenolol, reduces wave reflection. Am J Hypertens 2008 Jun; 21 (6): 663-667
21. Arosio E, De Marchi S, Prior M, et al. Effects of nebivolol and atenolol on small arteries and microcirculatory endothelium-dependent dilation in hypertensive patients undergoing isometric stress. J Hypertens 2002; 20 (9): 1793-1797
22. Evangelista S, Garbin U, Pasini AF, et al. Effect of dl-nebivolol, its enantiomers and metabolites on the intracellular production of superoxide and nitric oxide in human endothelial cells. Pharmacol Res 2007; 55 (4): 303-309
23. Mason RP, Kalinowski L, Jacob RF, et al. Nebivolol reduces nitroxidative stress and restores nitric oxide bioavailability in endothelium of Black Americans. Circulation 2005 Dec 13; 112 (24): 3795-3801
24. Tran Quang T, Rozec B, Audigane L, et al. Investigation of the different adrenoceptor targets of nebivolol enantiomers in rat thoracic aorta. Br J Pharmacol 2009; 156: 601-608
25. Pasini AF, Garbin U, Stranieri C, et al. Nebivolol treatment reduces serum levels of asymmetric dimethylarginine and improves endothelial dysfunction in essential hypertensive patients. Am J Hypertens 2008 Nov; 21 (11): 1251-1257
26. Pronko TP, Zinchuk VV. Effect of nebivolol on blood oxygen transport indices and endothelial dysfunction in patients with arterial hypertension. Clin Physiol Funct Imaging 2009 May; 29 (3): 170-176
27. Kamali F, Howes A, Thomas SH, et al. A pharmacokinetic and pharmacodynamic interaction study between nebivolol and the H2-receptor antagonists cimetidine and ranitidine. Br J Clin Pharmacol 1997 Feb; 43 (2): 201-204
28. Gu Z, Robinson RA, Cai L, et al. Metabolism study of 14C-nebivolol in humans with different CYP2D6 genotypes [online]. Available from URL: http:// www.aapsj.org/abstracts/AM-2003/AAPS2003-002800.pdf [Accessed 2009 Mar 12]
29. Lawrence TE, Liu S, Donnelly CM, et al. A phase I open-label multiple dose study assessing the pharmacokinetic interaction of hydrochlorothiazide and nebivolol HCl in healthy volunteers [online]. Available from URL: http:// www.aapsj.org/abstracts/Am-2003/AAPS2003-000443.PDF [Accessed 2009 Mar 10]
30. Lawrence TE, Chien C, Tu HC, et al. No effect of concomitant administration of nebivolol and losartan in healthy volunteers genotyped for CYP2D6 status [abstract no. PII-121]. Clin Pharmacol Ther 2005 Feb; 77 (2): 82
31. Lawrence TE, Liu S, Bland TM, et al. Single-dose pharmacokinetics and anticoagulant activity of warfarin is unaffected by nebivolol in healthy volunteers [abstract no. PI-121]. Clin Pharmacol Ther 2005 Feb; 77 (2): 39
32. Lawrence TE, Liu S, Fisher JW, et al. No interaction between nebivolol and digoxin in healthy volunteers [abstract no. PII-98]. Clin Pharmacol Ther 2005 Feb; 77 (2): 76
33. Morton TL, Liu S, Phillips JL, et al. No pharmacokinetic interaction between nebivolol and furosemide in healthy subjects [abstract no. PII-107]. Clin Pharmacol Ther 2005 Feb; 77 (2): 79
34. Morton TL, Tu HC, Liu S, et al. Lack of pharmacokinetic interaction between nebivolol and spironolactone [abstract no. PI-148]. Clin Pharmacol Ther 2005 Feb; 77 (2): 46
35. Morton TL, Liu S, Phillips JL, et al. Pharmacokinetics of nebivolol and ramipril are not affected by co-administration [abstract no. PII-101]. Clin Pharmacol Ther 2005 Feb; 77 (2): 77
36. Shaw AA, Liu S, Zachwieja LF, et al. Effect of chronic administration of fluoxetine on the pharmacokinetics of nebivolol [abstract no. PI-116]. Clin Pharmacol Ther 2005 Feb; 77 (2): 38
37. Greathouse MD. Nebivolol efficacy and safety in patients with stage I-II hypertension. Clin Cardiol. In press
38. Weiss RJ, Weber MA, Carr AA, et al. A randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of nebivolol, a novel b-blocker, in patients with mild to moderate hypertension. J Clin Hypertens (Greenwich) 2007 Sep; 9 (9): 667-676
39. Saunders E, Smith WB, DeSalvo KB, et al. The efficacy and tolerability of nebivolol in hypertensive African American patients. J Clin Hypertens (Greenwich) 2007 Nov; 9 (11): 866-875
40. Neutel JM, Smith DHG, Gradman AH. Adding nebivolol to ongoing antihypertensive therapy improves blood pressure and response rates in patients with uncontrolled stage I-II hypertension. J Human Hypertens. Epub 2009 Apr 30
41. Papademetriou V. Comparison of nebivolol monotherapy versus nebivolol in combination with other antihypertensive therapies for the treatment of hypertension. Am J Cardiol 2009 Jan 15; 103 (2): 273-278
42. US FDA. NDA 21742 nebivolol tablets Bertek Pharmaceuticals, Inc. [online]. Available from URL: http://www.fda.gov/cder/foi/nda/2007/021742s000- MedR-P8.pdf [Accessed 2009 Mar 16]
43. Gradman AH. Safety and tolerability of nebivolol: a pooled analysis of safety analysis comparing typical b-blocker associated adverse events with placebo. J Clin Hypertens 2008 May 1; 10 (Suppl. A. No. 5): 120