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Volumn 49, Issue 12, 2009, Pages 1436-1446

Absence of effect of telbivudine on cardiac repolarization: Results of a thorough QT/QTc study in healthy participants

Author keywords

Cardiac repolarization; Pharmacodynamics; Pharmacokinetics; QT QTc interval; Telbivudine

Indexed keywords

MOXIFLOXACIN; PLACEBO; TELBIVUDINE;

EID: 71449093977     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270009337943     Document Type: Article
Times cited : (10)

References (28)
  • 2
    • 4544271613 scopus 로고    scopus 로고
    • A dose-finding study of once-daily oral telbivudine in HBeAg-positive patients with chronic hepatitis B virus infection
    • Lai CL, Lim SG, Brown NA, et al. A dose-finding study of once-daily oral telbivudine in HBeAg-positive patients with chronic hepatitis B virus infection. Hepatology. 2004 ; 40: 719-726.
    • (2004) Hepatology , vol.40 , pp. 719-726
    • Lai, C.L.1    Lim, S.G.2    Brown, N.A.3
  • 4
    • 37349120537 scopus 로고    scopus 로고
    • Telbivudine versus lamivudine in patients with chronic hepatitis B
    • Lai CL, Gane E., Liaw YF, et al. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med. 2007 ; 357: 2576-2588.
    • (2007) N Engl J Med , vol.357 , pp. 2576-2588
    • Lai, C.L.1    Gane, E.2    Liaw, Y.F.3
  • 5
    • 38449093445 scopus 로고    scopus 로고
    • Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: A randomized trial
    • Chan HL, Heathcote EJ, Marcellin P., et al. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 ; 147: 745-754.
    • (2007) Ann Intern Med , vol.147 , pp. 745-754
    • Chan, H.L.1    Heathcote, E.J.2    Marcellin, P.3
  • 7
    • 33644662858 scopus 로고    scopus 로고
    • Pharmacokinetics of telbivudine following oral administration of escalating single and multiple doses in patients with chronic hepatitis B virus infection: Pharmacodynamic implications
    • Zhou XJ, Lim SG, Lloyd DM, Chao GC, Brown NA, Lai CL Pharmacokinetics of telbivudine following oral administration of escalating single and multiple doses in patients with chronic hepatitis B virus infection: pharmacodynamic implications. Antimicrob Agents Chemother. 2006 ; 50: 874-879.
    • (2006) Antimicrob Agents Chemother , vol.50 , pp. 874-879
    • Zhou, X.J.1    Lim, S.G.2    Lloyd, D.M.3    Chao, G.C.4    Brown, N.A.5    Lai, C.L.6
  • 9
    • 22444444118 scopus 로고    scopus 로고
    • Drugs effects on ventricular repolarization: A critical evaluation of the strengths and weaknesses of current methodologies and regulatory practices
    • Bass AS, Tomaselli G., Bullingham R III, Kinter LB Drugs effects on ventricular repolarization: a critical evaluation of the strengths and weaknesses of current methodologies and regulatory practices. J Pharmacol Toxicol Methods. 2005 ; 52: 12-21.
    • (2005) J Pharmacol Toxicol Methods , vol.52 , pp. 12-21
    • Bass, A.S.1    Tomaselli, G.2    Bullingham Iii, R.3    Kinter, L.B.4
  • 10
    • 27544448562 scopus 로고    scopus 로고
    • Methodological considerations in the design of trials for safety assessment of new drugs and chemical entities
    • Pater C. Methodological considerations in the design of trials for safety assessment of new drugs and chemical entities. Curr Control Trials Cardiovasc Med. 2005 ; 6: 1-13.
    • (2005) Curr Control Trials Cardiovasc Med , vol.6 , pp. 1-13
    • Pater, C.1
  • 11
    • 1542345445 scopus 로고    scopus 로고
    • Pharmacogenetic aspects of drug-induced Torsade de Pointes: Potential tool for improving clinical drug development and prescribing
    • Shah RR Pharmacogenetic aspects of drug-induced Torsade de Pointes: potential tool for improving clinical drug development and prescribing. Drug Saf. 2004 ; 27: 145-172.
    • (2004) Drug Saf , vol.27 , pp. 145-172
    • Shah, R.R.1
  • 12
    • 2142660225 scopus 로고    scopus 로고
    • QT prolongation and fatal arrhythmias: A review of clinical implications and effects of drugs
    • Cubeddu LX QT prolongation and fatal arrhythmias: a review of clinical implications and effects of drugs. Am J Ther. 2003 ; 10: 452-457.
    • (2003) Am J Ther , vol.10 , pp. 452-457
    • Cubeddu, L.X.1
  • 13
    • 27244456179 scopus 로고    scopus 로고
    • 14 Step 5. the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
    • Ich E. 14 Step 5. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Federal Register. 2005 ; 70: 61134-61135.
    • (2005) Federal Register , vol.70 , pp. 61134-61135
    • Ich, E.1
  • 14
    • 46249105009 scopus 로고    scopus 로고
    • Nonclinical safety profile of telbivudine, a novel potent antiviral agent for treatment of hepatitis B
    • Bridges EG, Selden JR, Luo S. Nonclinical safety profile of telbivudine, a novel potent antiviral agent for treatment of hepatitis B. Antimicrob Agents Chemother. 2008 ; 52: 2521-2528.
    • (2008) Antimicrob Agents Chemother , vol.52 , pp. 2521-2528
    • Bridges, E.G.1    Selden, J.R.2    Luo, S.3
  • 15
    • 33745584135 scopus 로고    scopus 로고
    • Pharmacokinetics of telbivudine in healthy subjects and absence of drug interaction with lamivudine or adefovir dipivoxil
    • Zhou XJ, Fielman BA, Lloyd DM, Chao GC, Brown NA Pharmacokinetics of telbivudine in healthy subjects and absence of drug interaction with lamivudine or adefovir dipivoxil. Antimicrob Agents Chemother. 2006 ; 50: 2309-2315.
    • (2006) Antimicrob Agents Chemother , vol.50 , pp. 2309-2315
    • Zhou, X.J.1    Fielman, B.A.2    Lloyd, D.M.3    Chao, G.C.4    Brown, N.A.5
  • 19
    • 37349079996 scopus 로고    scopus 로고
    • Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review
    • Garnett CE, Beasley N., Bhattaram VA, et al. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol. 2008 ; 48: 13-18.
    • (2008) J Clin Pharmacol , vol.48 , pp. 13-18
    • Garnett, C.E.1    Beasley, N.2    Bhattaram, V.A.3
  • 21
    • 41549161099 scopus 로고    scopus 로고
    • Effect of levetiracetam on cardiac repolarization in healthy subjects: A single-dose, randomized, placebo- and active-controlled, four-way crossover study
    • Hulhoven R., Rosillon D., Bridson WE, Meeus MA, Salas E., Stockis A. Effect of levetiracetam on cardiac repolarization in healthy subjects: a single-dose, randomized, placebo- and active-controlled, four-way crossover study. Clin Ther. 2008 ; 30: 260-270.
    • (2008) Clin Ther , vol.30 , pp. 260-270
    • Hulhoven, R.1    Rosillon, D.2    Bridson, W.E.3    Meeus, M.A.4    Salas, E.5    Stockis, A.6
  • 22
    • 44049105253 scopus 로고    scopus 로고
    • Raltegravir thorough QT/QTc study: A single supratherapeutic dose of raltegravir does not prolong the QTcF interval
    • Iwamoto M., Kost JT, Mistry GC, et al. Raltegravir thorough QT/QTc study: a single supratherapeutic dose of raltegravir does not prolong the QTcF interval. J Clin Pharmacol. 2008 ; 48: 726-733.
    • (2008) J Clin Pharmacol , vol.48 , pp. 726-733
    • Iwamoto, M.1    Kost, J.T.2    Mistry, G.C.3
  • 23
    • 33645790554 scopus 로고    scopus 로고
    • Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline
    • Darp B., Nebout T., Sager PT Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline. J Clin Pharmacol. 2006 ; 46: 498-507.
    • (2006) J Clin Pharmacol , vol.46 , pp. 498-507
    • Darp, B.1    Nebout, T.2    Sager, P.T.3
  • 24
    • 33748942458 scopus 로고    scopus 로고
    • Cirrhotic cardiomyopathy
    • Al Hamoudi W., Lee SS Cirrhotic cardiomyopathy. Ann Hepatol. 2006 ; 5: 132-139.
    • (2006) Ann Hepatol , vol.5 , pp. 132-139
    • Al Hamoudi, W.1    Lee, S.S.2
  • 25
    • 38549172857 scopus 로고    scopus 로고
    • Cardiovascular complications of cirrhosis
    • Moller S., Henriksem JH Cardiovascular complications of cirrhosis. Gut. 2008 ; 57: 268-278.
    • (2008) Gut , vol.57 , pp. 268-278
    • Moller, S.1    Henriksem, J.H.2
  • 26
    • 33645779759 scopus 로고    scopus 로고
    • Cardiac electrophysiological abnormalities in patients with cirrhosis
    • Zambruni A., Trevisani F., Caraceni P., Bernardi M. Cardiac electrophysiological abnormalities in patients with cirrhosis. J Hepatol. 2006 ; 44: 994-1002.
    • (2006) J Hepatol , vol.44 , pp. 994-1002
    • Zambruni, A.1    Trevisani, F.2    Caraceni, P.3    Bernardi, M.4
  • 27
    • 71449086937 scopus 로고    scopus 로고
    • Lack of association between Mayo end-stage liver disease score and QTc interval
    • Carey EJ, Douglas DD, Mulligan DC, et al. Lack of association between Mayo end-stage liver disease score and QTc interval. Am J Gastroenterol. 2001 ; 96 (suppl). Abstract 369.
    • (2001) Am J Gastroenterol. , vol.96 , pp. 369
    • Carey, E.J.1    Douglas, D.D.2    Mulligan, D.C.3
  • 28
    • 0035742548 scopus 로고    scopus 로고
    • Prolonged QTc interval and its relationship to autonomic cardiovascular reflexes in patients with cirrhosis
    • Puthumana L., Chaudhry V., Thuluvath PJ Prolonged QTc interval and its relationship to autonomic cardiovascular reflexes in patients with cirrhosis. J Hepatol. 2001 ; 35: 733-738.
    • (2001) J Hepatol , vol.35 , pp. 733-738
    • Puthumana, L.1    Chaudhry, V.2    Thuluvath, P.J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.