Models for evaluating the pharmacokinetics and pharmacodynamics for β-blockers

Bibliography

• Frishman WH. beta-Adrenergic blockers: a 50-year historical perspective. Am J Ther 2008;15:565-76
   PubMed Web of Science ®Google Scholar
• Mancia G, Fagard R, Narkiewicz K, et al. 2013 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;31:1281-357
   PubMed Web of Science ®Google Scholar
• Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC), Steg PG, James SK, Atar D, et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J 2012;33:2569-619
   PubMed Web of Science ®Google Scholar
• Yusuf S. The use of beta-adrenergic blocking agents, i.v. nitrates and calcium channel blocking agents following acute myocardial infarction. Chest 1988;93(1 Suppl):25S-8S
   PubMed Web of Science ®Google Scholar
• McMurray JJ, Adamopoulos S, Anker SD, et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J 2012;33:1787-847
   PubMed Web of Science ®Google Scholar
• Frishman WH, Alwarshetty M. Beta-adrenergic blockers in systemic hypertension: pharmacokinetic considerations related to the current guidelines. Clin Pharmacokinet 2002;41:505-16
   PubMed Web of Science ®Google Scholar
• Patel K, Kirkpatrick CM. Pharmacokinetic concepts revisited – basic and applied. Curr Pharm Biotechnol 2011;12:1983-90
   PubMed Web of Science ®Google Scholar
• Lu H. Stereoselectivity in drug metabolism. Expert Opin Drug Metab Toxicol 2007;3:149-58
   PubMed Web of Science ®Google Scholar
• Mehvar R, Brocks DR. Stereospecific pharmacokinetics and pharmacodynamics of beta-adrenergic blockers in humans. J Pharm Pharm Sci 2001;4:185-200
   PubMed Web of Science ®Google Scholar
• Höcht C, Bertera FM, Mayer MA, et al. Issues in drug metabolism of major antihypertensive drugs: beta-blockers, calcium channel antagonists and angiotensin receptor blockers. Expert Opin Drug Metab Toxicol 2010;6:199-211
   PubMed Web of Science ®Google Scholar
• Bertera FM, Del Mauro JS, Chiappetta D, et al. Enantioselective pharmacokinetic and pharmacodynamic properties of carvedilol in spontaneously hypertensive rats: focus on blood pressure variability. Naunyn Schmiedebergs Arch Pharmacol 2012;385:325-35
   PubMed Web of Science ®Google Scholar
• Bertera F, Di Verniero CA, Mayer MA, et al. Pharmacokinetic and pharmacodynamic properties of carvedilol in fructose hypertensive rats. Xenobiotica 2012;42:206-19
   PubMed Web of Science ®Google Scholar
• Di Verniero CA, Bertera F, Buontempo F, et al. Enantioselective pharmacokinetic-pharmacodynamic modelling of carvedilol in a N-nitro-l-arginine methyl ester rat model of secondary hypertension. J Pharm Pharmacol 2010;62:890-900
   PubMed Web of Science ®Google Scholar
• Bertera FM, Del Mauro JS, Polizio AH, et al. Effect of nebivolol on beat-to-beat and short-term blood pressure variability in spontaneously hypertensive rats. Naunyn Schmiedebergs Arch Pharmacol 2012;385:833-43
   PubMed Web of Science ®Google Scholar
• McAinsh J, Holmes BF, Smith S, et al. Atenolol kinetics in renal failure. Clin Pharmacol Ther 1980;28:302-9
   PubMed Web of Science ®Google Scholar
• Berglund G, Descamps R, Thomis JA. Pharmacokinetics of sotalol after chronic administration to patients with renal insufficiency. Eur J Clin Pharmacol 1980;18:321-6
   PubMed Web of Science ®Google Scholar
• Payton CD, Fox JG, Pauleau NF, et al. The single dose pharmacokinetics of bisoprolol (10 mg) in renal insufficiency: the clinical significance of balanced clearance. Eur Heart J 1987;8:15-22
   PubMedGoogle Scholar
• Gehr TW, Tenero DM, Boyle DA, et al. The pharmacokinetics of carvedilol and its metabolites after single and multiple dose oral administration inpatients with hypertension and renal insufficiency. Eur J Clin Pharmacol 1999;55:269-77
   PubMed Web of Science ®Google Scholar
• Drozdzik M, Domanski L, Wojcicki J, et al. Effect of unilateral nephrectomy on the pharmacokinetics of atenolol in humans. J Clin Pharmacol 2003;43:524-8
   PubMed Web of Science ®Google Scholar
• O'Hare MF, Kinney CD, Murnaghan GA, et al. Pharmacokinetics of propranolol during pregnancy. Eur J Clin Pharmacol 1984;27:583-7
   PubMed Web of Science ®Google Scholar
• O'Hare MF, Leahey W, Murnaghan GA, et al. Pharmacokinetics of sotalol during pregnancy. Eur J Clin Pharmacol 1983;24:521-4
   PubMed Web of Science ®Google Scholar
• Rogers RC, Sibai BM, Whybrew WD. Labetalol pharmacokinetics in pregnancy-induced hypertension. Am J Obstet Gynecol 1990;162:362-6
   PubMed Web of Science ®Google Scholar
• Läer S, Mir TS, Behn F, et al. Carvedilol therapy in pediatric patients with congestive heart failure: a study investigating clinical and pharmacokinetic parameters. Am Heart J 2002;143:916-22
   PubMed Web of Science ®Google Scholar
• Buck ML, Wiest D, Gillette PC, et al. Pharmacokinetics and pharmacodynamics of atenolol in children. Clin Pharmacol Ther 1989;46:629-33
   PubMed Web of Science ®Google Scholar
• Saul JP, Schaffer MS, Karpawich PP, et al. Single-dose pharmacokinetics of sotalol in a pediatric population with supraventricular and/or ventricular tachyarrhythmia. J Clin Pharmacol 2001;41:35-43
   PubMed Web of Science ®Google Scholar
• Riddell JG, Neill JD, Kelly JG, et al. Effects of thyroid dysfunction on propranolol kinetics. Clin Pharmacol Ther 1980;28:565-74
   PubMed Web of Science ®Google Scholar
• Nestorov I. Whole-body physiologically based pharmacokinetic models. Expert Opin Drug Metab Toxicol 2007;3:235-49
   PubMed Web of Science ®Google Scholar
• Shardlow C, Generaux G, Patel A, et al. Impact of physiologically-based pharmacokinetic modelling and simulation in drug development. Drug Metab Dispos 2013;41(12):1994-2003
   PubMed Web of Science ®Google Scholar
• Jones H, Rowland-Yeo K. Basic concepts in physiologically based pharmacokinetic modeling in drug discovery and development. CPT Pharmacometrics Syst Pharmacol 2013;2:e63
   PubMedGoogle Scholar
• Rowland M, Peck C, Tucker G. Physiologically-based pharmacokinetics in drug development and regulatory science. Annu Rev Pharmacol Toxicol 2011;51:45-73
   PubMed Web of Science ®Google Scholar
• Levitt DG. PKQuest: a general physiologically based pharmacokinetic model. Introduction and application to propranolol. BMC Clin Pharmacol 2002;2:5
   PubMedGoogle Scholar
• Gaohua L, Abduljalil K, Jamei M, et al. A pregnancy physiologically based pharmacokinetic (p-PBPK) model for disposition of drugs metabolized by CYP1A2, CYP2D6 and CYP3A4. Br J Clin Pharmacol 2012;74:873-85
   PubMed Web of Science ®Google Scholar
• Aarons L. Population pharmacokinetics: theory and practice. Br J Clin Pharmacol 1991;32:669-70
   PubMed Web of Science ®Google Scholar
• Honda M, Nozawa T, Igarashi N, et al. Effect of CYP2D6*10 on the pharmacokinetics of R- and S-carvedilol in healthy Japanese volunteers. Biol Pharm Bull 2005;28:1476-9
   PubMed Web of Science ®Google Scholar
• Honda M, Ogura Y, Toyoda W, et al. Multiple regression analysis of pharmacogenetic variability of carvedilol disposition in 54 healthy Japanese volunteers. Biol Pharm Bull 2006;29:772-8
   PubMed Web of Science ®Google Scholar
• Albers S, Meibohm B, Mir TS, et al. Population pharmacokinetics and dose simulation of carvedilol in paediatric patients with congestive heart failure. Br J Clin Pharmacol 2008;65:511-22
   PubMed Web of Science ®Google Scholar
• Nikolic VN, Jankovic SM, Velickovic-Radovanović R, et al. Population pharmacokinetics of carvedilol in patients with congestive heart failure. J Pharm Sci 2013;102:2851-8
   PubMed Web of Science ®Google Scholar
• Othman AA, Tenero DM, Boyle DA, et al. Population pharmacokinetics of S(-)-carvedilol in healthy volunteers after administration of the immediate-release (IR) and the new controlled-release (CR) dosage forms of the racemate. AAPS J 2007;9:E208-18
   PubMed Web of Science ®Google Scholar
• Taguchi M, Nozawa T, Mizumaki K, et al. Nonlinear mixed effects model analysis of the pharmacokinetics of metoprolol in routinely treated Japanese patients. Biol Pharm Bull 2004;27:1642-8
   PubMed Web of Science ®Google Scholar
• Taguchi M, Nozawa T, Kameyama T, et al. Effect of CYP2D6*10 on pharmacokinetic variability of routinely administered metoprolol in middle-aged and elderly Japanese patients. Eur J Clin Pharmacol 2003;59:385-8
   PubMed Web of Science ®Google Scholar
• Nikolic VN, Jevtovic-Stoimenov T, Velickovic-Radovanović R, et al. Population pharmacokinetics of bisoprolol in patients with chronic heart failure. Eur J Clin Pharmacol 2013;69:859-65
   PubMed Web of Science ®Google Scholar
• Derendorf H, Lesko LJ, Chaikin P, et al. Pharmacokinetic/pharmacodynamic modeling in drug research and development. J Clin Pharmacol 2000;40:1399-418
   PubMed Web of Science ®Google Scholar
• Balant LP, Gex-Fabry M, Balant-Gorgia E. Drug metabolism as a confounding factor in PK/PD population approaches. Therapie 1996;51:390-8
   PubMed Web of Science ®Google Scholar
• Toutain PL. Pharmacokinetic/pharmacodynamic integration in drug development and dosage-regimen optimization for veterinary medicine. AAPS PharmSci 2002;4:E38
   PubMedGoogle Scholar
• Pérez-Urizar J, Granados-Soto V, Flores-Murrieta FJ, et al. Pharmacokinetic-pharmacodynamic modeling: why? Arch Med Res 2000;31:539-45
   PubMed Web of Science ®Google Scholar
• Bhushan R, Dixit S. Amino acids as chiral selectors in enantioresolution by liquid chromatography. Biomed Chromatogr 2012;26:962-71
   PubMed Web of Science ®Google Scholar
• Bojarski J. Stereoselective chromatography of cardiovascular drugs: an update. J Biochem Biophys Methods 2002;54:197-220
   PubMedGoogle Scholar
• Davies CL. Chromatography of beta-adrenergic blocking agents. J Chromatogr 1990;531:131-80
   PubMed Web of Science ®Google Scholar
• Desai M, Stockbridge N, Temple R. Blood pressure as an example of a biomarker that functions as a surrogate. AAPS J 2006;8:E146-52
   PubMed Web of Science ®Google Scholar
• Hori M, Okamoto H. Heart rate as a target of treatment of chronic heart failure. J Cardiol 2012;60:86-90
   PubMed Web of Science ®Google Scholar
• Höcht C, Mayer M, Opezzo JAW, et al. Pharmacokinetic-pharmacodynamic modeling of antihypertensive drugs: from basic research to clinical practice. Curr Hypertens Rev 2008;4:289-302
   Google Scholar
• Höcht C, Opezzo JAW, Bramuglia GF, et al. Application of microdialysis for pharmacokinetic–pharmacodynamic modeling. Expert Opin Drug Discov 2006;1:289-301
   PubMed Web of Science ®Google Scholar
• Höcht C, Di Verniero C, Opezzo JA, et al. Applicability of microdialysis as a technique for pharmacokinetic-pharmacodynamic (PK-PD) modeling of antihypertensive beta-blockers. J Pharmacol Toxicol Methods 2005;52:244-50
   PubMedGoogle Scholar
• Höcht C, Di Verniero C, Opezzo JA, et al. Pharmacokinetic-pharmacodynamic properties of metoprolol in chronic aortic coarctated rats. Naunyn Schmiedebergs Arch Pharmacol 2004;370:1-8
   PubMed Web of Science ®Google Scholar
• Harder S, Thürmann P, Rietbrock N. Concentration/Effect Analysis of Antihypertensive Drugs. Am J Ther 1994;1:116-24
   PubMedGoogle Scholar
• van Steeg TJ, Freijer J, Danhof M, et al. Pharmacokinetic-pharmacodynamic modelling of S(-)-atenolol in rats: reduction of isoprenaline-induced tachycardia as a continuous pharmacodynamic endpoint. Br J Pharmacol 2007;151:356-66
   PubMed Web of Science ®Google Scholar
• von Bahr C, Collste P, Frisk-Holmberg M, et al. Plasma levels and effects of metoprolol on blood pressure, adrenergic beta receptor blockade, and plasma renin activity in essential hypertension. Clin Pharmacol Ther 1976;20:130-7
   PubMed Web of Science ®Google Scholar
• Myers MG, Thiessen JJ. Metoprolol kinetics and dose response in hypertensive patients. Clin Pharmacol Ther 1980;27:756-62
   PubMed Web of Science ®Google Scholar
• Sklar J, Johnston GD, Overlie P, et al. The effects of a cardioselective (metoprolol) and a nonselective (propranolol) beta-adrenergic blocker on the response to dynamic exercise in normal men. Circulation 1982;65:894-9
   PubMed Web of Science ®Google Scholar
• Leonetti G, Mayer G, Morganti A, et al. Hypotensive and renin-suppressing activities of propranolol in hypertensive patients. Clin Sci Mol Med Suppl 1975;48:491-9
   PubMedGoogle Scholar
• Esler M, Zweifler A, Randall O, et al. Pathophysiologic and pharmacokinetic determinants of the antihypertensive response to propranolol. Clin Pharmacol Ther 1977;22:299-308
   PubMed Web of Science ®Google Scholar
• Brynne L, Karlsson MO, Paalzow LK. Concentration-effect relationship of l-propranolol and metoprolol in spontaneous hypertensive rats after exercise-induced tachycardia. J Pharmacol Exp Ther 1998;286:1152-8
   PubMed Web of Science ®Google Scholar
• Meredith PA. Clinical relevance of optimal pharmacokinetics in the treatment of hypertension. J Hypertens Suppl 1997;15:S27-31
   PubMedGoogle Scholar
• Stauss HM. Identification of blood pressure control mechanisms by power spectral analysis. Clin Exp Pharmacol Physiol 2007;34:362-8
   PubMed Web of Science ®Google Scholar
• Bertera FM, Del Mauro JS, Lovera V, et al. Acute effects of third generation beta-blockers on short-term and beat-to-beat blood pressure variability in sinoaortic-denervated rats. Hypertens Res 2013;36:349-55
   PubMed Web of Science ®Google Scholar
• Tenero DM, Henderson LS, Campanile AM, et al. Development of a pharmacokinetic/pharmacodynamic model for carvedilol to predict beta1-blockade in patients with congestive heart failure. Am J Cardiol 2006;98:27L-31L
   PubMed Web of Science ®Google Scholar
• Liu XY, Wang BJ, Yuan GY, et al. Comparison of different pharmacodynamic models for pharmacokinetic-pharmacodynamic (PK-PD) modeling of carvedilol. Yao Xue Xue Bao 2009;44:406-11
   PubMedGoogle Scholar
• Danhof M, de Lange EC, Della Pasqua OE, et al. Mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling in translational drug research. Trends Pharmacol Sci 2008;29:186-91
   PubMed Web of Science ®Google Scholar
• van Steeg TJ, Boralli VB, Krekels EH, et al. Influence of plasma protein binding on pharmacodynamics: estimation of in vivo receptor affinities of beta blockers using a new mechanism-based PK-PD modelling approach. J Pharm Sci 2009;98:3816-28
   PubMed Web of Science ®Google Scholar
• Snelder N, Ploeger BA, Luttringer O, et al. PKPD modelling of the interrelationship between mean arterial BP, cardiac output and total peripheral resistance in conscious rats. Br J Pharmacol 2013;169:1510-24
   PubMed Web of Science ®Google Scholar
• Man in't Veld AJ, Van den Meiracker AH, Schalekamp MA. Do beta-blockers really increase peripheral vascular resistance? Review of the literature and new observations under basal conditions. Am J Hypertens 1988;1:91-6
   PubMed Web of Science ®Google Scholar
• Celardo A, Traina GL, Arboix M, et al. Pharmacokinetic and pharmacodynamic modelling of atenolol in rabbits maintained on continuous peritoneal dialysis. Eur J Drug Metab Pharmacokinet 1987;12:41-8
   PubMed Web of Science ®Google Scholar
• Bortolotti A, Castelli D, Verotta D, et al. Pharmacokinetic and pharmacodynamic modelling of metoprolol in rabbits with liver failure. Eur J Drug Metab Pharmacokinet 1989;14:145-51
   PubMed Web of Science ®Google Scholar
• Bertera FM, Di Verniero CA, Mayer MA, et al. Is urethane-chloralose anaesthesia appropriate for pharmacokinetic-pharmacodynamic assessment? Studies with carvedilol. J Pharmacol Toxicol Methods 2009;59:13-20
   PubMedGoogle Scholar
• Luzier AB, Killian A, Wilton JH, et al. Gender-related effects on metoprolol pharmacokinetics and pharmacodynamics in healthy volunteers. Clin Pharmacol Ther 1999;66:594-601
   PubMed Web of Science ®Google Scholar
• Scott PJ, Meredith PA, Kelman AW, et al. The effects of age on the pharmacokinetics and pharmacodynamics of cardiovascular drugs: application of concentration-effect modeling. 2. Acebutolol. Am J Ther 1995;2:537-40
   PubMedGoogle Scholar
• Baek IH, Yun MH, Yun HY, et al. Pharmacokinetic/pharmacodynamic modeling of the cardiovascular effects of beta blockers in humans. Arch Pharm Res 2008;31:814-21
   PubMed Web of Science ®Google Scholar
• Saotome T, Minoura S, Terashi K, et al. Labetalol in hypertension during the third trimester of pregnancy: its antihypertensive effect and pharmacokinetic-dynamic analysis. J Clin Pharmacol 1993;33:979-88
   PubMed Web of Science ®Google Scholar
• Wiysonge CS, Bradley HA, Volmink J, et al. Beta-blockers for hypertension. Cochrane Database Syst Rev 2012;11:CD002003
   PubMedGoogle Scholar
• Ram CV. Beta-blockers in hypertension. Am J Cardiol 2010;106:1819-25
   PubMed Web of Science ®Google Scholar
• Rothwell PM, Howard SC, Dolan E, et al. Effects of beta blockers and calcium-channel blockers on within-individual variability in blood pressure and risk of stroke. Lancet Neurol 2010;9:469-80
   PubMed Web of Science ®Google Scholar
• Saito M, Kawana J, Ohno T, et al. Population pharmacokinetics of R- and S-carvedilol in Japanese patients with chronic heart failure. Biol Pharm Bull 2010;33:1378-84
   PubMed Web of Science ®Google Scholar
• Di Verniero CA, Silberman EA, Mayer MA, et al. In vitro and in vivo pharmacodynamic properties of metoprolol in fructose-fed hypertensive rats. J Cardiovasc Pharmacol 2008;51:532-41
   PubMed Web of Science ®Google Scholar
• Yin XX, Zhang YD. Pharmacokinetic-pharmacodynamic modeling of metoprolol enantiomers in the dog. Yao Xue Xue Bao 1997;32:411-15
   PubMedGoogle Scholar
• Ritchie RH, Morgan DJ, Horowitz JD. Myocardial effect compartment modeling of metoprolol and sotalol: importance of myocardial subsite drug concentration. J Pharm Sci 1998;87:177-82
   PubMed Web of Science ®Google Scholar
• Landersdorfer CB, Jusko WJ. Pharmacokinetic/pharmacodynamic modelling in diabetes mellitus. Clin Pharmacokinet 2008;47:417-48
   PubMed Web of Science ®Google Scholar