메뉴 건너뛰기




Volumn 33, Issue 7, 2011, Pages 851-862

A Placebo- and Active-Controlled Assessment of 6- and 50-mg Oral Doxepin on Cardiac Repolarization in Healthy Volunteers: A Thorough QT Evaluation

Author keywords

Doxepin; Insomnia; Moxifloxacin; Nordoxepin; Thorough QT study

Indexed keywords

DOXEPIN; MOXIFLOXACIN; NORDOXEPIN; PLACEBO;

EID: 79960282682     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2011.05.092     Document Type: Article
Times cited : (11)

References (35)
  • 1
    • 79952587747 scopus 로고    scopus 로고
    • Efficacy and safety of doxepin 6 mg in a model of transient Insomnia
    • Roth T., Durrence H., Jochelson P., et al. Efficacy and safety of doxepin 6 mg in a model of transient Insomnia. Sleep Med 2010, 11:843-847.
    • (2010) Sleep Med , vol.11 , pp. 843-847
    • Roth, T.1    Durrence, H.2    Jochelson, P.3
  • 2
    • 34548249175 scopus 로고    scopus 로고
    • Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in adults with primary insomnia
    • Roth T., Rogowski R., Hull S., et al. Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in adults with primary insomnia. Sleep 2007, 30:1555-1561.
    • (2007) Sleep , vol.30 , pp. 1555-1561
    • Roth, T.1    Rogowski, R.2    Hull, S.3
  • 3
    • 78649842406 scopus 로고    scopus 로고
    • Efficacy and safety of doxepin 1 mg and 3 mg in a 12-week sleep laboratory and outpatient trial of elderly subjects with chronic primary insomnia
    • Krystal A.D., Durrence H.H., Scharf M., et al. Efficacy and safety of doxepin 1 mg and 3 mg in a 12-week sleep laboratory and outpatient trial of elderly subjects with chronic primary insomnia. Sleep 2011, 33:1553-1561.
    • (2011) Sleep , vol.33 , pp. 1553-1561
    • Krystal, A.D.1    Durrence, H.H.2    Scharf, M.3
  • 4
    • 0001875379 scopus 로고    scopus 로고
    • Drugs used in the treatment of psychiatric disorders
    • McGraw-Hill, New York, J.G. Hardman, A.G. Gilman, L.E. Limbird (Eds.)
    • Baldessarini R.J. Drugs used in the treatment of psychiatric disorders. Goodman & Gillman's The Pharmacological Basis of Therapeutics 1996, 431-459. McGraw-Hill, New York. 9th ed. J.G. Hardman, A.G. Gilman, L.E. Limbird (Eds.).
    • (1996) Goodman & Gillman's The Pharmacological Basis of Therapeutics , pp. 431-459
    • Baldessarini, R.J.1
  • 5
    • 0028358474 scopus 로고
    • Binding of antidepressants to human brain receptors: focus on newer generation compounds
    • Cusack B., Nelson A., Richelson E. Binding of antidepressants to human brain receptors: focus on newer generation compounds. Psychopharmacology (Berl) 1994, 114:559-565.
    • (1994) Psychopharmacology (Berl) , vol.114 , pp. 559-565
    • Cusack, B.1    Nelson, A.2    Richelson, E.3
  • 6
    • 0031565115 scopus 로고    scopus 로고
    • Pharmacological profile of antidepressants and related compounds at human monoamine transporters
    • Tatsumi M., Groshan K., Blakely R.D., Richelson E. Pharmacological profile of antidepressants and related compounds at human monoamine transporters. Eur J Pharmacol 1997, 340:249-258.
    • (1997) Eur J Pharmacol , vol.340 , pp. 249-258
    • Tatsumi, M.1    Groshan, K.2    Blakely, R.D.3    Richelson, E.4
  • 7
    • 0036094878 scopus 로고    scopus 로고
    • Psychotropic drugs and the ECG: focus on the QTc interval
    • Goodnick P., Jerry J., Parra F. Psychotropic drugs and the ECG: focus on the QTc interval. Expert Opin Pharmacother 2002, 3:479-498.
    • (2002) Expert Opin Pharmacother , vol.3 , pp. 479-498
    • Goodnick, P.1    Jerry, J.2    Parra, F.3
  • 8
    • 0017336951 scopus 로고
    • Doxepin up-to-date: a review of its pharmacological properties and therapeutic efficacy with particular reference to depression
    • Pinder R.M., Brogden R.N., Speight T.M., Avery G.S. Doxepin up-to-date: a review of its pharmacological properties and therapeutic efficacy with particular reference to depression. Drugs 1977, 13:161-218.
    • (1977) Drugs , vol.13 , pp. 161-218
    • Pinder, R.M.1    Brogden, R.N.2    Speight, T.M.3    Avery, G.S.4
  • 10
    • 0031022154 scopus 로고    scopus 로고
    • Electrocardiographic effects of fluoxetine and doxepin in patients with major depressive disorder
    • Baker B., Dorian P., Sandor P., et al. Electrocardiographic effects of fluoxetine and doxepin in patients with major depressive disorder. J Clin Psychopharmacol 1997, 17:15-21.
    • (1997) J Clin Psychopharmacol , vol.17 , pp. 15-21
    • Baker, B.1    Dorian, P.2    Sandor, P.3
  • 11
    • 0020083550 scopus 로고
    • Cardiovascular effects of tricyclic antidepressants in depressed patients with chronic heart disease
    • Veith R.C., Raskind M.A., Caldwell J.H., et al. Cardiovascular effects of tricyclic antidepressants in depressed patients with chronic heart disease. N Engl J Med 1982, 306:954-959.
    • (1982) N Engl J Med , vol.306 , pp. 954-959
    • Veith, R.C.1    Raskind, M.A.2    Caldwell, J.H.3
  • 12
    • 0023186269 scopus 로고
    • Cardiovascular effects of doxepin in cardiac patients with ventricular arrhythmias
    • Giardina E.G., Cooper T.B., Suckow R., Saroff A.L. Cardiovascular effects of doxepin in cardiac patients with ventricular arrhythmias. Clin Pharmacol Ther 1987, 42:20-27.
    • (1987) Clin Pharmacol Ther , vol.42 , pp. 20-27
    • Giardina, E.G.1    Cooper, T.B.2    Suckow, R.3    Saroff, A.L.4
  • 13
    • 0034901881 scopus 로고    scopus 로고
    • Serum levels and cardiovascular effects of tricyclic antidepressants and selective serotonin reuptake inhibitors in depressed patients
    • Rodriguez de la Torre B., Dreher J., Malvany I., et al. Serum levels and cardiovascular effects of tricyclic antidepressants and selective serotonin reuptake inhibitors in depressed patients. Thera Drug Monit 2001, 23:435-440.
    • (2001) Thera Drug Monit , vol.23 , pp. 435-440
    • Rodriguez de la Torre, B.1    Dreher, J.2    Malvany, I.3
  • 14
    • 0021748491 scopus 로고
    • Comparative cardiac effects of maprotiline and doxepin in elderly depressed patients
    • Ahles S., Gwirtsman H., Halaris A., et al. Comparative cardiac effects of maprotiline and doxepin in elderly depressed patients. J Clin Psychiatry 1984, 45:460-465.
    • (1984) J Clin Psychiatry , vol.45 , pp. 460-465
    • Ahles, S.1    Gwirtsman, H.2    Halaris, A.3
  • 15
    • 0016715519 scopus 로고
    • Assessment of cardiovascular side effects of therapeutic doses of tricyclic anti-depressant drugs
    • Vohra J., Burrows G., Sloman G. Assessment of cardiovascular side effects of therapeutic doses of tricyclic anti-depressant drugs. Aust N Z J Med 1975, 5:7-11.
    • (1975) Aust N Z J Med , vol.5 , pp. 7-11
    • Vohra, J.1    Burrows, G.2    Sloman, G.3
  • 16
    • 0027228160 scopus 로고
    • A comparison of the cardiac safety and therapeutic efficacy of trimipramine versus doxepin in depressed geriatric patients
    • Nair N.P., Amin M., Schwartz G., et al. A comparison of the cardiac safety and therapeutic efficacy of trimipramine versus doxepin in depressed geriatric patients. J Am Geriatr Soc 1993, 41:863-867.
    • (1993) J Am Geriatr Soc , vol.41 , pp. 863-867
    • Nair, N.P.1    Amin, M.2    Schwartz, G.3
  • 17
    • 0018133801 scopus 로고
    • Dosage schedule and plasma levels of doxepin and desmethyldoxepin
    • Biggs J.T., Preskorn S.H., Ziegler V.E., et al. Dosage schedule and plasma levels of doxepin and desmethyldoxepin. J Clin Psychiatry 1978, 39:740-742.
    • (1978) J Clin Psychiatry , vol.39 , pp. 740-742
    • Biggs, J.T.1    Preskorn, S.H.2    Ziegler, V.E.3
  • 18
    • 0017970177 scopus 로고
    • Clinical importance of doxepin antidepressant plasma levels
    • Green D.O. Clinical importance of doxepin antidepressant plasma levels. J Clin Psychiatry 1978, 39:481-482.
    • (1978) J Clin Psychiatry , vol.39 , pp. 481-482
    • Green, D.O.1
  • 19
    • 0020639904 scopus 로고
    • Multiple-dose doxepin kinetics in depressed patients
    • Faulkner R., Pitts W., Lee C., et al. Multiple-dose doxepin kinetics in depressed patients. Clin Pharmacol Ther 1983, 34:509-515.
    • (1983) Clin Pharmacol Ther , vol.34 , pp. 509-515
    • Faulkner, R.1    Pitts, W.2    Lee, C.3
  • 20
    • 50349099149 scopus 로고    scopus 로고
    • The effect of moxifloxacin on QTc and implications for the design of thorough QT studies
    • Bloomfield D.M., Kost J.T., Ghosh K., et al. The effect of moxifloxacin on QTc and implications for the design of thorough QT studies. Clin Pharmacol Ther 2008, 84:475-480.
    • (2008) Clin Pharmacol Ther , vol.84 , pp. 475-480
    • Bloomfield, D.M.1    Kost, J.T.2    Ghosh, K.3
  • 21
    • 77949388473 scopus 로고    scopus 로고
    • No cardiac effects of therapeutic and supratherapeutic doses of rupatadine: results from a thorough QT/QTc study' performed according to ICH guidelines
    • Donado E., Izquierdo I., Pérez I., et al. No cardiac effects of therapeutic and supratherapeutic doses of rupatadine: results from a thorough QT/QTc study' performed according to ICH guidelines. Br J Clin Pharmacol 2010, 69:401-410.
    • (2010) Br J Clin Pharmacol , vol.69 , pp. 401-410
    • Donado, E.1    Izquierdo, I.2    Pérez, I.3
  • 22
    • 77951498815 scopus 로고    scopus 로고
    • Effects of the selective alpha 1a-adrenoceptor antagonist silodosin on ECGs of healthy men in a randomized, double-blind, placebo- and moxifloxacin-controlled study
    • Morganroth J., Lepor H., Hill L.A., et al. Effects of the selective alpha 1a-adrenoceptor antagonist silodosin on ECGs of healthy men in a randomized, double-blind, placebo- and moxifloxacin-controlled study. Clin Pharmacol Ther 2010, 87:609-613.
    • (2010) Clin Pharmacol Ther , vol.87 , pp. 609-613
    • Morganroth, J.1    Lepor, H.2    Hill, L.A.3
  • 23
    • 44949228934 scopus 로고    scopus 로고
    • Assessing QT variability in healthy volunteers. In: Thirty-second annual ACCP meeting abstracts
    • Agin M.A., Kazierad D.J., Abel R., et al. Assessing QT variability in healthy volunteers. In: Thirty-second annual ACCP meeting abstracts. J Clin Pharmacol 2003, 43:1016-1040.
    • (2003) J Clin Pharmacol , vol.43 , pp. 1016-1040
    • Agin, M.A.1    Kazierad, D.J.2    Abel, R.3
  • 24
    • 54949128640 scopus 로고    scopus 로고
    • Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in elderly patients with primary insomnia: a randomized, double-blind, placebo-controlled crossover study
    • Scharf M., Rogowski R., Hull S., et al. Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in elderly patients with primary insomnia: a randomized, double-blind, placebo-controlled crossover study. J Clin Psychiatry 2008, 69:1557-1564.
    • (2008) J Clin Psychiatry , vol.69 , pp. 1557-1564
    • Scharf, M.1    Rogowski, R.2    Hull, S.3
  • 25
    • 33644961372 scopus 로고    scopus 로고
    • Antidepressants: their effects on cardiac channels, QT prolongation and torsade de pointes
    • Sala M., Coppa F., Cappucciati C., et al. Antidepressants: their effects on cardiac channels, QT prolongation and torsade de pointes. Curr Opinion Invest Drugs 2006, 7:256-263.
    • (2006) Curr Opinion Invest Drugs , vol.7 , pp. 256-263
    • Sala, M.1    Coppa, F.2    Cappucciati, C.3
  • 26
    • 47549087939 scopus 로고    scopus 로고
    • Cardiotoxic effects of antihistamines: from basics to clinics (and back)
    • Soldovieri M.V., Miceli F., Taglialatela M. Cardiotoxic effects of antihistamines: from basics to clinics (and back). Chem Res Toxicol 2008, 21:997-1004.
    • (2008) Chem Res Toxicol , vol.21 , pp. 997-1004
    • Soldovieri, M.V.1    Miceli, F.2    Taglialatela, M.3
  • 27
    • 0029761822 scopus 로고    scopus 로고
    • HERG, a primary human ventricular target of the nonsedating antihistamine terfenadine
    • Roy M., Dumaine R., Brown A.M. HERG, a primary human ventricular target of the nonsedating antihistamine terfenadine. Circulation 1996, 94:817-823.
    • (1996) Circulation , vol.94 , pp. 817-823
    • Roy, M.1    Dumaine, R.2    Brown, A.M.3
  • 28
    • 68349146244 scopus 로고    scopus 로고
    • Structural determinants for histamine H(1) affinity, hERG affinity and QTc prolongation in a series of terfenadine analogs
    • Aslanian R., Piwinski J.J., Zhu X., et al. Structural determinants for histamine H(1) affinity, hERG affinity and QTc prolongation in a series of terfenadine analogs. Bioorg Med Chem Lett 2009, 19:5043-5047.
    • (2009) Bioorg Med Chem Lett , vol.19 , pp. 5043-5047
    • Aslanian, R.1    Piwinski, J.J.2    Zhu, X.3
  • 29
    • 34250749314 scopus 로고    scopus 로고
    • Inhibition of the HERG potassium channel by the tricyclic antidepressant doxepin
    • Duncan R.S., McPate M.J., Ridley J.M., et al. Inhibition of the HERG potassium channel by the tricyclic antidepressant doxepin. Biochemical Pharmacol 2007, 74:425-437.
    • (2007) Biochemical Pharmacol , vol.74 , pp. 425-437
    • Duncan, R.S.1    McPate, M.J.2    Ridley, J.M.3
  • 30
    • 0032789964 scopus 로고    scopus 로고
    • ECG abnormalities in tricyclic antidepressant ingestion
    • Harrigan R.A., Brady W.J. ECG abnormalities in tricyclic antidepressant ingestion. Am J Emerg Med 1999, 17:387-393.
    • (1999) Am J Emerg Med , vol.17 , pp. 387-393
    • Harrigan, R.A.1    Brady, W.J.2
  • 31
    • 0035806986 scopus 로고    scopus 로고
    • Doxepin-induced torsade de pointes tachycardia
    • Alter P., Tontsch D., Grimm W. Doxepin-induced torsade de pointes tachycardia. Ann Intern Med 2001, 135:384-385.
    • (2001) Ann Intern Med , vol.135 , pp. 384-385
    • Alter, P.1    Tontsch, D.2    Grimm, W.3
  • 34
    • 0344492207 scopus 로고    scopus 로고
    • Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety margin in drug development
    • Redfern W.S., Carlsson L., Davis A.S., et al. Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety margin in drug development. Cardiovas Res 2003, 58:32-45.
    • (2003) Cardiovas Res , vol.58 , pp. 32-45
    • Redfern, W.S.1    Carlsson, L.2    Davis, A.S.3
  • 35
    • 0034922147 scopus 로고    scopus 로고
    • Doxepin plasma concentrations: is there really a therapeutic range?
    • Leucht S., Steimer W., Kreuz S., et al. Doxepin plasma concentrations: is there really a therapeutic range?. J Clin Psychopharmacol 2001, 21:432-439.
    • (2001) J Clin Psychopharmacol , vol.21 , pp. 432-439
    • Leucht, S.1    Steimer, W.2    Kreuz, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.