Fixed-dose combination therapy of nebivolol and valsartan for the treatment of hypertension

References

• James PA, Oparil S, Carter BL, et al. evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507–520.
   PubMed Web of Science ®Google Scholar
• SPRINT Research Group, Wright JT Jr, Williamson JD, Whelton PK, et al. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med 2015;373(22):2103–2116.
   PubMed Web of Science ®Google Scholar
• Chobanian AV, Bakris GL, Black HR, et al. The seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure: the JNC 7 report. JAMA. 2003;289(19):2560–2572.
   PubMed Web of Science ®Google Scholar
• Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2015;pii:S0140–6736(15)01225-8. doi:10.1016/S0140-6736(15)01225-8.
   Google Scholar
• Mancia G, Fagard R, Narkiewicz K, et al. ESH/ESC guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013;31(7):1281–1357.
   PubMed Web of Science ®Google Scholar
• Mancia G, Fagard R, Narkiewicz K, et al. ESH/ESC guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J. 2013;34(28):2159–2219.
   PubMed Web of Science ®Google Scholar
• Briasoulis A, Bakris G. Initial single-pill combination therapy for cardiovascular risk factor management: it is not just convenience. J Hypertens. 2013;31(8):1537–1538.
   PubMed Web of Science ®Google Scholar
• Atlas S. The renin-angiotensin aldosterone system: pathophysiological role and pharmacologic inhibition. J Manag V Care Pharm. 2007;13(8 Suppl B):9–20.
   PubMed Web of Science ®Google Scholar
• Bakris G. An in-depth analysis of vasodilation in the management of hypertension: focus on adrenergic blockade. J Cardiovasc Pharmacol. 2009;53(5):379–387.
   PubMed Web of Science ®Google Scholar
• Skeberdis VA. Structure and function of beta3-adrenergic receptors. Medicina (Kaunas). 2004;40(5):407–413.
   PubMedGoogle Scholar
• Giles TD, Weber MA, Basile J, et al. Efficacy and safety of nebivolol and valsartan as fixed-dose combination in hypertension: a randomised, multicentre study. Lancet. 2014;383(9932):1889–1898.
   PubMed Web of Science ®Google Scholar
• Feng MG, Prieto MC, Navar LG. Nebivolol-induced vasodilation of renal afferent arterioles involves β3-adrenergic receptor and nitric oxide synthase activation. Am J Physiol Renal Physiol. 2012;303(5):F775–82.
   PubMed Web of Science ®Google Scholar
• Forstermann U, Munzel T. Endothelial nitric oxide synthase in vascular disease: from marvel to menace. Circulation. 2006;113:1708–1714.
   PubMed Web of Science ®Google Scholar
• Forstermann U, Sessa WC. Nitric oxide synthases: regulation and function. Eur Heart J. 2012;33(7):829–837.
   PubMed Web of Science ®Google Scholar
• Li H, Wallerath T, Förstermann U. Physiological mechanisms regulating the expression of endothelial-type NO synthase. Nitric Oxide. 2002;7(2):132–147.
   PubMed Web of Science ®Google Scholar
• Munzel T, Gori T. Nebivolol: the somewhat-different beta-adrenergic receptor blocker. J Am Coll Cardiol. 2009;54(16):1491–1499.
   PubMed Web of Science ®Google Scholar
• Caplin B, Leiper J. Endogenous nitric oxide synthase inhibitors in the biology of disease: markers, mediators, and regulators? Arterioscler Thromb Vasc Biol. 2012;32(6):1343–1353.
   PubMed Web of Science ®Google Scholar
• Kandavar R, Higashi Y, Chen W, et al. The effect of nebivolol versus metoprolol succinate extended release on asymmetric dimethylarginine in hypertension. J Am Soc Hypertens. 2011;5(3):161–165.
   PubMed Web of Science ®Google Scholar
• Khan BV, Rahman ST, Haque T, et al. Vascular effects of nebivolol added to hydrochlorothiazide in African Americans with hypertension and echocardiographic evidence of diastolic dysfunction: the NASAA study. J Cardiovas Pharmacol Ther. 2012;17(3):291–297.
   PubMed Web of Science ®Google Scholar
• Gao YS, Nagao T, Bond RA, et al. Nebivolol induces endothelium dependent relaxatíons of canine coronary arteries. J Cardiovas Pharmacol. 1991;17(6):964–969.
   PubMed Web of Science ®Google Scholar
• Oelze M, Daiber A, Brandes RP, et al. Nebivolol inhibits superoxide formation by NADPH oxidase and endothelial dysfunction in angiotensin II-treated rats. Hypertens. 2006;48(4):677–684.
   PubMed Web of Science ®Google Scholar
• Szabo C, Ischiropoulos H, Radi R. Peroxynitrite: biochemistry, pathophysiology and development of therapeutics. Nature Rev Drug Dis. 2007;6(8):662–680.
   PubMed Web of Science ®Google Scholar
• De Groot AA, Mathy MJ, Van Zwieten PA, et al. Antioxidant activity of nebivolol in the rat aorta. J Cardiovasc Pharmacol. 2004;43(1):148–153.
   PubMed Web of Science ®Google Scholar
• Mason RP, Kubant R, Jacob RF, et al. Effect of nebivolol on endothelial nitric oxide and release in hypertensive animals: Role of antioxidant activity. J Cardiovasc Pharmacol. 2006;48(1):862–869.
   PubMed Web of Science ®Google Scholar
• Kamp O, Sieswerda GT, Visser CA. Comparison of effects on systolic and diastolic left ventricular function of nebivolol versus atenolol in patients with uncomplicated essential hypertension. Am J Cardiol. 2003;92(3):344–348.
   PubMed Web of Science ®Google Scholar
• Dhakam Z, Yasmin, McEniery CM, et al. A comparison of atenolol and nebivolol in isolated systolic hypertension. J Hypertens. 2008;26(2):351–356.
   PubMed Web of Science ®Google Scholar
• Carella AM, Antonucci G, Conte M, et al. Antihypertensive treatment with beta-blockers in the metabolic syndrome: a review. Curr Diabetes Rev. 2010;6(4):215–221.
   PubMedGoogle Scholar
• Chan TY, Woo KS, Nicholls MG. The application of nebivolol in essential hypertension: a double-blind, randomized, placebo-controlled study. Int J Cardiol. 1992;35(3):387–395.
   PubMed Web of Science ®Google Scholar
• Mollnau H, Schulz E, Daiber A, et al. Nebivolol prevents vascular NOS III uncoupling in experimental hyperlipidemia and inhibits NADPH oxidase activity in inflammatory cells. Arterioscler Thromb Vasc Biol. 2003;23(4):615–621.
   PubMed Web of Science ®Google Scholar
• Weber M. The role of the new beta-blockers in treating cardiovascular disease. Am J Hypertens. 2005;18(12 Pt 2):169S-176S.
   PubMed Web of Science ®Google Scholar
• Mason RP, Jacob RF, Corbalan JJ, et al The favorable kinetics and balance of nebivolol-stimulated nitric oxide and peroxynitrite release in human endothelial cells. BMC Pharmacol Toxicol. 2013;14:48.
   PubMed Web of Science ®Google Scholar
• Gunebakmaz O, Kaya MG, Koc F, et al. Does nebivolol prevent contrast-induced nephropathy in humans? Clin Cardiol. 2012;35(4):250–254.
   PubMed Web of Science ®Google Scholar
• Duranay M, Kanbay M, Akay H, et al. Nebivolol improves renal function in patients who underwent angioplasty due to renal artery stenosis: a pilot study. Nephron Clin Pract. 2010;114(3):c213–7.
   PubMedGoogle Scholar
• Vinereanu D, Gherghinescu C, Ciobanu AO, et al. Reversal of subclinical left ventricular dysfunction by antihypertensive treatment: a prospective trial of nebivolol against metoprolol. J Hypertens. 2011;29(4):809–817.
   PubMed Web of Science ®Google Scholar
• Zhou X, Ma L, Habibi J, et al. Nebivolol improves diastolic dysfunction and myocardial remodeling through reductions in oxidative stressin the Zucker obese rat. Hypertension. 2010;55(4):880–888.
   PubMed Web of Science ®Google Scholar
• Nodari S, Metra M, Dei CL. Beta-blocker treatment of patients with diastolic heart failure and arterial hypertension. A prospective, randomized, comparison of the long- term effects of atenolol vs. nebivolol. Eur J Heart Fail. 2003;5(5):621–627.
   PubMed Web of Science ®Google Scholar
• Brehm BR, Wolf SC, Gorner S, et al. Effect of nebivolol on left ventricular function in patients with chronic heart failure: a pilot study. Eur J Heart Fail. 2002;4(6):757–763.
   PubMed Web of Science ®Google Scholar
• Lombardo RM, Reina C, Abrignani MG, et al. Effects of nebivolol versus carvedilol on left ventricular function in patients with chronic heart failure and reduced left ventricular systolic function. Am J Cardiovasc Drugs. 2006;6(4):259–263.
   PubMedGoogle Scholar
• Edes I, Gasior Z, Wita K. Effects of nebivolol on left ventricular function in elderly patients with chronic heart failure: results of the ENECA study. Eur J Heart Fail. 2005;7(4):631–639.
   PubMed Web of Science ®Google Scholar
• Dickstein K, Cohen-Solal A, Filippatos G, et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the task force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European society of cardiology. Developed in collaboration with the heart failure association of the ESC (HEART FAILURE) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008;29(19):2388–2442.
   PubMed Web of Science ®Google Scholar
• Dickstein K, Cohen-Solal A, Filippatos G, et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the task force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European society of cardiology. Developed in collaboration with the heart failure association of the ESC (HEART FAILUREA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur J Heart Fail. 2008;10(10):933–989.
   PubMed Web of Science ®Google Scholar
• Varagic J, Ahmad S, Brosnihan KB, et al. Salt-induced renal injury in spontaneously hypertensive rats: effects of nebivolol. Am J Nephrol. 2010;32(6):557–566.
   PubMed Web of Science ®Google Scholar
• Varagic J, Ahmad S, Voncannon JL, et al. Nebivolol reduces cardiac angiotensin II, associated oxidative stress and fibrosis but not arterial pressure in salt-loaded spontaneously hypertensive rats. J Hypertens. 2012;30(9):1766–1774.
   PubMed Web of Science ®Google Scholar
• Saunders E, Smith WB, DeSalvo KB, et al. The efficacy and tolerability of nebivolol in hypertensive African American patients. J Clin Hypertens (Greenwich). 2007;9(11):866–875.
   PubMedGoogle Scholar
• Mason RP, Kalinowski L, Jacob RF, et al. Nebivolol reduces nitroxidative stress and restores nitric oxide bioavailability in endothelium of black Americans. Circulation. 2005;112(24):3795–3801.
   PubMed Web of Science ®Google Scholar
• Vlachopoulos C, Aznaouridis K, O’Rourke MF, et al. Prediction of cardiovascular events and all-cause mortality with central haemodynamics: a systematic review and meta-analysis. Eur Heart J. 2010;31(15):1865–1871.
   PubMed Web of Science ®Google Scholar
• Wang KL, Cheng HM, Chuang SY, et al. Central or peripheral systolic or pulse pressure: which best relates to target organs and future mortality? J Hypertens. 2009;27(3):461–467.
   PubMed Web of Science ®Google Scholar
• Williams B, Lacy PS, Thom SM, et al. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. Circulation. 2006;113(9):1213–1225.
   PubMed Web of Science ®Google Scholar
• Parving HH, Lehnert H, Brochner-Mortensen J, et al. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. New Engl J Med. 2001;345(12):870–878.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Kollias G, Argyris AA, et al. Association of left ventricular diastolic dysfunction with 24-h aortic ambulatory blood pressure: the SAFAR study. J Hum Hypertens. 2015;29:442–448.
   PubMed Web of Science ®Google Scholar
• Tomlinson LA, Selvarajah V, Wilkinson IB. Rate-limiting step: can different effects of antihypertensives on central blood pressure be translated into outcomes? Hypertens. 2011;57(6):1047–1048.
   PubMed Web of Science ®Google Scholar
• Kampus P, Serg M, Kals J, et al. Differential effects of nebivolol and metoprolol on central aortic pressure and left ventricular wall thickness. Hypertens. 2011;57(6):1122–1128.
   PubMed Web of Science ®Google Scholar
• Koumaras C, Tziomalos K, Stavrinou E, et al. Effects of renin-angiotensin-aldosterone system inhibitors and beta-blockers on markers of arterial stiffness. J Am Soc Hypertens. 2014;8(2):74–82.
   PubMed Web of Science ®Google Scholar
• Studinger P, Tabak AG, Chen CH, et al. The effect of low-dose carvedilol, nebivolol, and metoprolol on central arterial pressure and its determinants: a randomized clinical trial. J Clin Hypertens (Greenwich). 2013;15(12):910–917.
   PubMed Web of Science ®Google Scholar
• Briasoulis A, Oliva R, Kalaitzidis R, et al. Effects of nebivolol on aortic compliance in patients with diabetes and maximal renin angiotensin system blockade: the EFFORT study. Clin Hypertens (Greenwich). 2013;15(7):473–479.
   PubMed Web of Science ®Google Scholar
• Hackenthal E, Paul M, Ganten D, et al. Morphology, physiology, and molecular biology of renin secretion. Physiol Rev. 1990;70(4):1067–1116.
   PubMed Web of Science ®Google Scholar
• Bomback AS, Klemmer PJ. The incidence and implications of aldosterone breakthrough. Nat Clin Pract Nephrol. 2007;3(9):486–492.
   PubMedGoogle Scholar
• Viberti G, Wheeldon NM. Microalbuminuria reduction with valsartan in patients with type 2 diabetes mellitus: a blood pressure-independent effect. Circulation. 2002;106(6):672–678.
   PubMed Web of Science ®Google Scholar
• Brenner BM, Cooper ME, De Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001;345(12):861–869.
   PubMed Web of Science ®Google Scholar
• Nishiyama A, Konishi Y, Ohashi N, et al. Urinary angiotensinogen reflects the activity of intrarenal renin-angiotensin system in patients with IgA nephropathy. Nephrol Dial Transplant. 2011;26(1):170–177.
   PubMed Web of Science ®Google Scholar
• Boutouyrie P, Achouba A, Trunet P, et al. Amlodipine-valsartan combination decreases central systolic blood pressure more effectively than the amlodipine-atenolol combination: the EXPLOR study. Hypertens. 2010;55(6):1314–1322.
   PubMed Web of Science ®Google Scholar
• Neutel JM, Giles TD, Punzi H, et al. Long-term safety of nebivolol and valsartan combination therapy in patients with hypertension: an open-label, single-arm, multicenter study. J Am Soc Hypertens. 2014;8(12):915–920.
   PubMed Web of Science ®Google Scholar
• Waeber B, Feihl F. Nebivolol and valsartan: useful treatment for hypertension? Lancet. 2014;383(9932):1864–1866.
   PubMed Web of Science ®Google Scholar
• Giles TD, Bakris GL, Oparil S, et al. Correlations of plasma renin activity and aldosterone concentration with ambulatory blood pressure responses to nebivolol and valsartan, alone and in combination, in hypertension. J AM Soc Hypertens. 2015;9(11):845–854.
   PubMed Web of Science ®Google Scholar
• Chen CL, Desai-Krieger D, Ortiz S, et al A single-center, open-label, 3-way crossover trial to determine the pharmacokinetic and pharmacodynamic interaction between nebivolol and valsartan in healthy volunteers at steady state. Am J Ther. 2015;22(5):e130–40.
   PubMed Web of Science ®Google Scholar
• Izzo JL Jr, Khan SU, Saleem O2, et al. Ambulatory 24-hour cardiac oxygen consumption and blood pressure-heart rate variability: effects of nebivolol and valsartan alone and in combination. J Am Soc Hypertens. 2015;9(7):526–535.
   PubMed Web of Science ®Google Scholar
• Cohn JN. Improving outcomes in congestive heart failure: Val-HeFT. Valsartan in Heart Failure Trial. Cardiology. 1999;91(Suppl 1):19–22.
   PubMed Web of Science ®Google Scholar
• Pfeffer MA, McMurray JJ, Velazquez EJ, et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med. 2003;349(20):1893–1906.
   PubMed Web of Science ®Google Scholar
• Flather MD, Shibata MC, Coats AJ, et al. Randomized trial to determine the effect of cardiovascular hospital admission in elderly patients with heart failure. Eur Heart J. 2005;26(3):215–225.
   PubMed Web of Science ®Google Scholar
• Ghio S, Magrini G, Serio A, et al. Effects of nebivolol in elderly heart failure patients with or without systolic left ventricular dysfunction: results of the SENIORS echocardiographic substudy. Eur Heart J. 2006;27(5):562–568.
   PubMed Web of Science ®Google Scholar
• Van Veldhuisen DJ, Cohen-Solal A, et al. Beta-blockade with nebivolol in elderly heart failure patients with impaired and preserved left ventricular ejection fraction: data from SENIORS (study of effects of nebivolol intervention on outcomes and rehospitalization in seniors with heart failure). J Am Coll Cardiol. 2009;53(23):2150–2158.
   PubMed Web of Science ®Google Scholar
• Jessup M. The heart failure paradox: an epidemic of scientific success. presidential address at the American heart association 2013 scientific sessions. Circulation. 2014;129(25):2717–2722.
   PubMed Web of Science ®Google Scholar
• Moniwa N, Varagic J, Ahmad S, et al. Hemodynamic and hormonal changes to dual renin-angiotensin system inhibition in experimental hypertension. Hypertension. 2013;61(2):417–424.
   PubMed Web of Science ®Google Scholar