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Volumn 35, Issue 6, 2013, Pages 819-835

Evaluation of pharmacokinetic and pharmacodynamic profiles and tolerability after single (2.5, 5, or 10 mg) and repeated (2.5, 5, or 10 mg bid for 4.5 days) oral administration of ivabradine in healthy male korean volunteers

Author keywords

Healthy individual; Ivabradine; Pharmacodynamics; Pharmacokinetics

Indexed keywords

IVABRADINE; PLACEBO; BENZAZEPINE DERIVATIVE;

EID: 84879459623     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2013.04.012     Document Type: Article
Times cited : (15)

References (45)
  • 1
    • 0019254317 scopus 로고
    • Heart rate as a prognostic factor for coronary heart disease and mortality: findings in three Chicago epidemiologic studies
    • Dyer A.R., Persky V., Stamler J., et al. Heart rate as a prognostic factor for coronary heart disease and mortality: findings in three Chicago epidemiologic studies. Am J Epidemiol 1980, 112:736-749.
    • (1980) Am J Epidemiol , vol.112 , pp. 736-749
    • Dyer, A.R.1    Persky, V.2    Stamler, J.3
  • 2
    • 0023223146 scopus 로고
    • Heart rate and cardiovascular mortality: the Framingham Study
    • Kannel W.B., Kannel C., Paffenbarger R.S., et al. Heart rate and cardiovascular mortality: the Framingham Study. Am Heart J 1987, 113:1489-1494.
    • (1987) Am Heart J , vol.113 , pp. 1489-1494
    • Kannel, W.B.1    Kannel, C.2    Paffenbarger, R.S.3
  • 3
    • 0030752019 scopus 로고    scopus 로고
    • The relationship between resting heart rate and all-cause, cardiovascular and cancer mortality
    • Mensink G.B., Hoffmeister H. The relationship between resting heart rate and all-cause, cardiovascular and cancer mortality. Eur Heart J 1997, 18:1404-1410.
    • (1997) Eur Heart J , vol.18 , pp. 1404-1410
    • Mensink, G.B.1    Hoffmeister, H.2
  • 4
    • 0033956592 scopus 로고    scopus 로고
    • The association of resting heart rate with cardiovascular, cancer and all-cause mortality. Eight year follow-up of 3527 male Israeli employees (the CORDIS Study)
    • Kristal-Boneh E., Silber H., Harari G., et al. The association of resting heart rate with cardiovascular, cancer and all-cause mortality. Eight year follow-up of 3527 male Israeli employees (the CORDIS Study). Eur Heart J 2000, 21:116-124.
    • (2000) Eur Heart J , vol.21 , pp. 116-124
    • Kristal-Boneh, E.1    Silber, H.2    Harari, G.3
  • 5
    • 0025308219 scopus 로고
    • Influence of heart rate on mortality after acute myocardial infarction
    • Hjalmarson A., Gilpin E.A., Kjekshus J., et al. Influence of heart rate on mortality after acute myocardial infarction. Am J Cardiol 1990, 65:547-553.
    • (1990) Am J Cardiol , vol.65 , pp. 547-553
    • Hjalmarson, A.1    Gilpin, E.A.2    Kjekshus, J.3
  • 6
    • 84860738847 scopus 로고    scopus 로고
    • Association of heart rate and outcomes in a broad spectrum of patients with chronic heart failure: results from the CHARM (Candesartan in Heart Failure: Assessment of Reduction in Mortality and morbidity) program
    • Castagno D., Skali H., Takeuchi M., et al. Association of heart rate and outcomes in a broad spectrum of patients with chronic heart failure: results from the CHARM (Candesartan in Heart Failure: Assessment of Reduction in Mortality and morbidity) program. J Am Coll Cardiol 2012, 59:1785-1795.
    • (2012) J Am Coll Cardiol , vol.59 , pp. 1785-1795
    • Castagno, D.1    Skali, H.2    Takeuchi, M.3
  • 7
    • 77954907723 scopus 로고    scopus 로고
    • Long-term prognostic importance of resting heart rate in patients with left ventricular dysfunction in connection with either heart failure or myocardial infarction: the DIAMOND study
    • Fosbol E.L., Seibaek M., Brendorp B., et al. Long-term prognostic importance of resting heart rate in patients with left ventricular dysfunction in connection with either heart failure or myocardial infarction: the DIAMOND study. Int J Cardiol 2010, 140:279-286.
    • (2010) Int J Cardiol , vol.140 , pp. 279-286
    • Fosbol, E.L.1    Seibaek, M.2    Brendorp, B.3
  • 8
    • 42149115647 scopus 로고    scopus 로고
    • Heart rate in the pathophysiology of coronary blood flow and myocardial ischaemia: benefit from selective bradycardic agents
    • Heusch G. Heart rate in the pathophysiology of coronary blood flow and myocardial ischaemia: benefit from selective bradycardic agents. Br J Pharmacol 2008, 153:1589-1601.
    • (2008) Br J Pharmacol , vol.153 , pp. 1589-1601
    • Heusch, G.1
  • 9
    • 78649688372 scopus 로고    scopus 로고
    • Vascular pathophysiology in response to increased heart rate
    • Custodis F., Schirmer S.H., Baumhakel M., et al. Vascular pathophysiology in response to increased heart rate. J Am Coll Cardiol 2010, 56:1973-1983.
    • (2010) J Am Coll Cardiol , vol.56 , pp. 1973-1983
    • Custodis, F.1    Schirmer, S.H.2    Baumhakel, M.3
  • 10
    • 84876702108 scopus 로고    scopus 로고
    • Heart rate as a therapeutic target in angina pectoris
    • Androulakis E., Tousoulis D., Papageorgiou N., et al. Heart rate as a therapeutic target in angina pectoris. Curr Pharm Des 2013, 19:1562-1568.
    • (2013) Curr Pharm Des , vol.19 , pp. 1562-1568
    • Androulakis, E.1    Tousoulis, D.2    Papageorgiou, N.3
  • 11
    • 0028322990 scopus 로고
    • Influence of the force-frequency relationship on haemodynamics and left ventricular function in patients with non-failing hearts and in patients with dilated cardiomyopathy
    • Hasenfuss G., Holubarsch C., Hermann H.P., et al. Influence of the force-frequency relationship on haemodynamics and left ventricular function in patients with non-failing hearts and in patients with dilated cardiomyopathy. Eur Heart J 1994, 15:164-170.
    • (1994) Eur Heart J , vol.15 , pp. 164-170
    • Hasenfuss, G.1    Holubarsch, C.2    Hermann, H.P.3
  • 12
    • 84865383976 scopus 로고    scopus 로고
    • Heart rate as a target of treatment of chronic heart failure
    • Hori M., Okamoto H. Heart rate as a target of treatment of chronic heart failure. J Cardiol 2012, 60:86-90.
    • (2012) J Cardiol , vol.60 , pp. 86-90
    • Hori, M.1    Okamoto, H.2
  • 15
    • 20444383848 scopus 로고    scopus 로고
    • Physiology and pharmacology of the cardiac pacemaker ("funny") current
    • Baruscotti M., Bucchi A., Difrancesco D. Physiology and pharmacology of the cardiac pacemaker ("funny") current. Pharmacol Ther 2005, 107:59-79.
    • (2005) Pharmacol Ther , vol.107 , pp. 59-79
    • Baruscotti, M.1    Bucchi, A.2    Difrancesco, D.3
  • 16
    • 0031578576 scopus 로고    scopus 로고
    • Stereospecific in vitro and in vivo effects of the new sinus node inhibitor (+)-S 16257
    • Thollon C., Bidouard J.P., Cambarrat C., et al. Stereospecific in vitro and in vivo effects of the new sinus node inhibitor (+)-S 16257. Eur J Pharmacol 1997, 339:43-51.
    • (1997) Eur J Pharmacol , vol.339 , pp. 43-51
    • Thollon, C.1    Bidouard, J.P.2    Cambarrat, C.3
  • 17
    • 0042357093 scopus 로고    scopus 로고
    • Electrophysiological effects of a single intravenous administration of ivabradine (S 16257) in adult patients with normal baseline electrophysiology
    • Camm A.J., Lau C.P. Electrophysiological effects of a single intravenous administration of ivabradine (S 16257) in adult patients with normal baseline electrophysiology. Drugs R D 2003, 4:83-89.
    • (2003) Drugs R D , vol.4 , pp. 83-89
    • Camm, A.J.1    Lau, C.P.2
  • 18
    • 0028358379 scopus 로고
    • Electrophysiological effects of S 16257, a novel sino-atrial node modulator, on rabbit and guinea-pig cardiac preparations: comparison with UL-FS 49
    • Thollon C., Cambarrat C., Vian J., et al. Electrophysiological effects of S 16257, a novel sino-atrial node modulator, on rabbit and guinea-pig cardiac preparations: comparison with UL-FS 49. Br J Pharmacol 1994, 112:37-42.
    • (1994) Br J Pharmacol , vol.112 , pp. 37-42
    • Thollon, C.1    Cambarrat, C.2    Vian, J.3
  • 19
    • 4544344025 scopus 로고    scopus 로고
    • Heart rate lowering by specific and selective I(f) current inhibition with ivabradine: a new therapeutic perspective in cardiovascular disease
    • DiFrancesco D., Camm J.A. Heart rate lowering by specific and selective I(f) current inhibition with ivabradine: a new therapeutic perspective in cardiovascular disease. Drugs 2004, 64:1757-1765.
    • (2004) Drugs , vol.64 , pp. 1757-1765
    • DiFrancesco, D.1    Camm, J.A.2
  • 20
    • 0037448788 scopus 로고    scopus 로고
    • Antianginal and antiischemic effects of ivabradine, an I(f) inhibitor, in stable angina: a randomized, double-blind, multicentered, placebo-controlled trial
    • Borer J.S., Fox K., Jaillon P., et al. Antianginal and antiischemic effects of ivabradine, an I(f) inhibitor, in stable angina: a randomized, double-blind, multicentered, placebo-controlled trial. Circulation 2003, 107:817-823.
    • (2003) Circulation , vol.107 , pp. 817-823
    • Borer, J.S.1    Fox, K.2    Jaillon, P.3
  • 21
    • 27944492366 scopus 로고    scopus 로고
    • Efficacy of ivabradine, a new selective I(f) inhibitor, compared with atenolol in patients with chronic stable angina
    • Tardif J.C., Ford I., Tendera M., et al. Efficacy of ivabradine, a new selective I(f) inhibitor, compared with atenolol in patients with chronic stable angina. Eur Heart J 2005, 26:2529-2536.
    • (2005) Eur Heart J , vol.26 , pp. 2529-2536
    • Tardif, J.C.1    Ford, I.2    Tendera, M.3
  • 22
    • 33947233212 scopus 로고    scopus 로고
    • Antianginal efficacy and safety of ivabradine compared with amlodipine in patients with stable effort angina pectoris: a 3-month randomised, double-blind, multicentre, noninferiority trial
    • Ruzyllo W., Tendera M., Ford I., et al. Antianginal efficacy and safety of ivabradine compared with amlodipine in patients with stable effort angina pectoris: a 3-month randomised, double-blind, multicentre, noninferiority trial. Drugs 2007, 67:393-405.
    • (2007) Drugs , vol.67 , pp. 393-405
    • Ruzyllo, W.1    Tendera, M.2    Ford, I.3
  • 23
    • 77956612624 scopus 로고    scopus 로고
    • Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study
    • Swedberg K., Komajda M., Bohm M., et al. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet 2010, 376:875-885.
    • (2010) Lancet , vol.376 , pp. 875-885
    • Swedberg, K.1    Komajda, M.2    Bohm, M.3
  • 24
    • 78951494836 scopus 로고    scopus 로고
    • Effect of heart rate reduction by ivabradine on left ventricular remodeling in the echocardiographic substudy of BEAUTIFUL
    • Ceconi C., Freedman S.B., Tardif J.C., et al. Effect of heart rate reduction by ivabradine on left ventricular remodeling in the echocardiographic substudy of BEAUTIFUL. Int J Cardiol 2011, 146:408-414.
    • (2011) Int J Cardiol , vol.146 , pp. 408-414
    • Ceconi, C.1    Freedman, S.B.2    Tardif, J.C.3
  • 25
    • 80051481733 scopus 로고    scopus 로고
    • Cardioprotection by ivabradine through heart rate reduction and beyond
    • Heusch G., Skyschally A., Schulz R. Cardioprotection by ivabradine through heart rate reduction and beyond. J Cardiovasc Pharmacol Ther 2011, 16:281-284.
    • (2011) J Cardiovasc Pharmacol Ther , vol.16 , pp. 281-284
    • Heusch, G.1    Skyschally, A.2    Schulz, R.3
  • 26
    • 80054742115 scopus 로고    scopus 로고
    • Effects of selective heart rate reduction with ivabradine on left ventricular remodelling and function: results from the SHIFT echocardiography substudy
    • Tardif J.C., O'Meara E., Komajda M., et al. Effects of selective heart rate reduction with ivabradine on left ventricular remodelling and function: results from the SHIFT echocardiography substudy. Eur Heart J 2011, 32:2507-2515.
    • (2011) Eur Heart J , vol.32 , pp. 2507-2515
    • Tardif, J.C.1    O'Meara, E.2    Komajda, M.3
  • 27
    • 11144356194 scopus 로고    scopus 로고
    • Long-term heart rate reduction induced by the selective I(f) current inhibitor ivabradine improves left ventricular function and intrinsic myocardial structure in congestive heart failure
    • Mulder P., Barbier S., Chagraoui A., et al. Long-term heart rate reduction induced by the selective I(f) current inhibitor ivabradine improves left ventricular function and intrinsic myocardial structure in congestive heart failure. Circulation 2004, 109:1674-1679.
    • (2004) Circulation , vol.109 , pp. 1674-1679
    • Mulder, P.1    Barbier, S.2    Chagraoui, A.3
  • 28
    • 84879464607 scopus 로고    scopus 로고
    • Procoralan: EPAR - Scientific Discussion. Servier Laboratories Ltd. Accessed March 25
    • Procoralan: EPAR - Scientific Discussion. Servier Laboratories Ltd. Accessed March 25, 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000597/human_med_000995.jsp&mid=WC0b01ac058001d124.
    • (2013)
  • 29
    • 0034109599 scopus 로고    scopus 로고
    • A pharmacokinetic simulation model for ivabradine in healthy volunteers
    • Duffull S.B., Chabaud S., Nony P., et al. A pharmacokinetic simulation model for ivabradine in healthy volunteers. Eur J Pharm Sci 2000, 10:285-294.
    • (2000) Eur J Pharm Sci , vol.10 , pp. 285-294
    • Duffull, S.B.1    Chabaud, S.2    Nony, P.3
  • 30
    • 33748671122 scopus 로고    scopus 로고
    • Effects of Hypericum perforatum on ivabradine pharmacokinetics in healthy volunteers: an open-label, pharmacokinetic interaction clinical trial
    • Portoles A., Terleira A., Calvo A., et al. Effects of Hypericum perforatum on ivabradine pharmacokinetics in healthy volunteers: an open-label, pharmacokinetic interaction clinical trial. J Clin Pharmacol 2006, 46:1188-1194.
    • (2006) J Clin Pharmacol , vol.46 , pp. 1188-1194
    • Portoles, A.1    Terleira, A.2    Calvo, A.3
  • 31
    • 79952257540 scopus 로고    scopus 로고
    • Pharmacokinetic interaction between ivabradine and carbamazepine in healthy volunteers
    • Vlase L., Neag M., Popa A., et al. Pharmacokinetic interaction between ivabradine and carbamazepine in healthy volunteers. J Clin Pharm Ther 2011, 36:225-229.
    • (2011) J Clin Pharm Ther , vol.36 , pp. 225-229
    • Vlase, L.1    Neag, M.2    Popa, A.3
  • 32
    • 84863586804 scopus 로고    scopus 로고
    • Pharmacokinetic interaction between ivabradine and phenytoin in healthy subjects
    • Vlase L., Popa A., Neag M., et al. Pharmacokinetic interaction between ivabradine and phenytoin in healthy subjects. Clin Drug Investig 2012, 32:533-538.
    • (2012) Clin Drug Investig , vol.32 , pp. 533-538
    • Vlase, L.1    Popa, A.2    Neag, M.3
  • 33
    • 0035183126 scopus 로고    scopus 로고
    • ICH harmonized tripartite guideline: Guideline for Good Clinical Practice
    • ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001;47:45-50.
    • (2001) J Postgrad Med. , vol.47 , pp. 45-50
  • 34
    • 78049235651 scopus 로고    scopus 로고
    • The Helsinki Declaration
    • The Helsinki Declaration. Assist Inferm Ric. 2010;29:41-44.
    • (2010) Assist Inferm Ric. , vol.29 , pp. 41-44
  • 35
    • 0343391203 scopus 로고    scopus 로고
    • Simultaneous determination of ivabradine and its metabolites in human plasma by liquid chromatography-tandem mass spectrometry
    • François-Bouchard M., Simonin G., Bossant, Boursier-Neyret C. Simultaneous determination of ivabradine and its metabolites in human plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B Biomed Sci Appl 2000, 745:261-269.
    • (2000) J Chromatogr B Biomed Sci Appl , vol.745 , pp. 261-269
    • François-Bouchard, M.1    Simonin, G.2    Bossant3    Boursier-Neyret, C.4
  • 37
    • 7544237334 scopus 로고    scopus 로고
    • A comparison of commonly used QT correction formulae: the effect of heart rate on the QTc of normal ECGs
    • Luo S., Michler K., Johnston P., et al. A comparison of commonly used QT correction formulae: the effect of heart rate on the QTc of normal ECGs. J Electrocardiol 2004, 37(Suppl):81-90.
    • (2004) J Electrocardiol , vol.37 , Issue.SUPPL , pp. 81-90
    • Luo, S.1    Michler, K.2    Johnston, P.3
  • 40
    • 33747886247 scopus 로고    scopus 로고
    • Clinical effect of 'pure' heart rate slowing with a prototype If current inhibitor: placebo-controlled experience with ivabradine
    • Borer J.S. Clinical effect of 'pure' heart rate slowing with a prototype If current inhibitor: placebo-controlled experience with ivabradine. Adv Cardiol 2006, 43:54-64.
    • (2006) Adv Cardiol , vol.43 , pp. 54-64
    • Borer, J.S.1
  • 41
    • 22744450757 scopus 로고    scopus 로고
    • Cardiac pacemaker I(f) current and its inhibition by heart rate-reducing agents
    • DiFrancesco D. Cardiac pacemaker I(f) current and its inhibition by heart rate-reducing agents. Curr Med Res Opin 2005, 21:1115-1122.
    • (2005) Curr Med Res Opin , vol.21 , pp. 1115-1122
    • DiFrancesco, D.1
  • 42
    • 72149118477 scopus 로고    scopus 로고
    • Efficacy of ivabradine, a selective I(f) inhibitor, in patients with chronic stable angina pectoris and diabetes mellitus
    • Borer J.S., Tardif J.C. Efficacy of ivabradine, a selective I(f) inhibitor, in patients with chronic stable angina pectoris and diabetes mellitus. Am J Cardiol 2010, 105:29-35.
    • (2010) Am J Cardiol , vol.105 , pp. 29-35
    • Borer, J.S.1    Tardif, J.C.2
  • 43
    • 79251601377 scopus 로고    scopus 로고
    • Rate control with ivabradine: angina pectoris and beyond
    • Parakh N., Bhargava B. Rate control with ivabradine: angina pectoris and beyond. Am J Cardiovasc Drugs 2011, 11:1-12.
    • (2011) Am J Cardiovasc Drugs , vol.11 , pp. 1-12
    • Parakh, N.1    Bhargava, B.2
  • 44
    • 0036020147 scopus 로고    scopus 로고
    • Current-dependent block of rabbit sino-atrial node I(f) channels by ivabradine
    • Bucchi A., Baruscotti M., DiFrancesco D. Current-dependent block of rabbit sino-atrial node I(f) channels by ivabradine. J Gen Physiol 2002, 120:1-13.
    • (2002) J Gen Physiol , vol.120 , pp. 1-13
    • Bucchi, A.1    Baruscotti, M.2    DiFrancesco, D.3
  • 45
    • 33847133030 scopus 로고    scopus 로고
    • Cellular mechanisms underlying the pharmacological induction of phosphenes
    • Cervetto L., Demontis G.C., Gargini C. Cellular mechanisms underlying the pharmacological induction of phosphenes. Br J Pharmacol 2007, 150:383-390.
    • (2007) Br J Pharmacol , vol.150 , pp. 383-390
    • Cervetto, L.1    Demontis, G.C.2    Gargini, C.3


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