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Volumn 39, Issue 4, 1999, Pages 349-358

Assessment of QTc prolongation for non-cardiac-related drugs from a drug development perspective

Author keywords

[No Author keywords available]

Indexed keywords

HALOPERIDOL; NEW DRUG; RISPERIDAL; RISPERIDONE; TERFENADINE; UNCLASSIFIED DRUG;

EID: 0032926293     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/00912709922007912     Document Type: Review
Times cited : (34)

References (37)
  • 1
    • 0025814624 scopus 로고
    • QTc prolongation measured by standard 12-lead ECG is an independent risk factor for sudden death due to cardiac arrest
    • Algra A, Tijssen JGP, Roelandt J, Pool J, Lubsen J: QTc prolongation measured by standard 12-lead ECG is an independent risk factor for sudden death due to cardiac arrest. Circulation 1991;83:1888-1894.
    • (1991) Circulation , vol.83 , pp. 1888-1894
    • Algra, A.1    Tijssen, J.G.P.2    Roelandt, J.3    Pool, J.4    Lubsen, J.5
  • 2
    • 0019428919 scopus 로고
    • Torsades de pointes: Electrophysiologic studies in patients without transient pharmacologic or metabolic abnormalities
    • Horowitz LN, Greenspan AM, Spielman SR, Josephson ME: Torsades de pointes: electrophysiologic studies in patients without transient pharmacologic or metabolic abnormalities. Circulation 1981;63:1120-1128.
    • (1981) Circulation , vol.63 , pp. 1120-1128
    • Horowitz, L.N.1    Greenspan, A.M.2    Spielman, S.R.3    Josephson, M.E.4
  • 3
    • 0017054884 scopus 로고
    • Quinidine syncope: Torsades de pointes with low quinidine plasma concentrations
    • Jenzer HR, Hagemeijer F: Quinidine syncope: torsades de pointes with low quinidine plasma concentrations. Eur J Cardiol 1976;4:447-451.
    • (1976) Eur J Cardiol , vol.4 , pp. 447-451
    • Jenzer, H.R.1    Hagemeijer, F.2
  • 4
    • 0029883856 scopus 로고    scopus 로고
    • Dose-response relation between terfenadine (Seldane) and the QTc interval on the scalar electrocardiogram: Distinguishing a drug effect from spontaneous variability
    • Pratt CM, Ruberg S, Morganroth J, McNutt B, Woodward J, Harris S, et al: Dose-response relation between terfenadine (Seldane) and the QTc interval on the scalar electrocardiogram: distinguishing a drug effect from spontaneous variability. Am Heart J 1996;131:472-480.
    • (1996) Am Heart J , vol.131 , pp. 472-480
    • Pratt, C.M.1    Ruberg, S.2    Morganroth, J.3    McNutt, B.4    Woodward, J.5    Harris, S.6
  • 5
    • 0027515633 scopus 로고
    • Female gender as a risk factor for torsades de pointes associated with cardiovascular drugs
    • Makkar RR, Fromm BS, Steinman RT, Meissner MD, Lehmann MH: Female gender as a risk factor for torsades de pointes associated with cardiovascular drugs. JAMA 1993;270:2590-2597.
    • (1993) JAMA , vol.270 , pp. 2590-2597
    • Makkar, R.R.1    Fromm, B.S.2    Steinman, R.T.3    Meissner, M.D.4    Lehmann, M.H.5
  • 6
    • 0023751667 scopus 로고
    • Evaluation of 10 QT prediction formulas in 881 middle-aged men from the seven countries study: Emphasis on the cubic root Fridericia's equation
    • Puddu PE, Jouve R, Mariotti S, Giampaoli S, Lanti M, Reale A, et al: Evaluation of 10 QT prediction formulas in 881 middle-aged men from the Seven Countries Study: emphasis on the cubic root Fridericia's equation. J Electrocardiol 1988;21:219-229.
    • (1988) J Electrocardiol , vol.21 , pp. 219-229
    • Puddu, P.E.1    Jouve, R.2    Mariotti, S.3    Giampaoli, S.4    Lanti, M.5    Reale, A.6
  • 7
    • 0027218947 scopus 로고
    • Rate-corrected QT interval: Techniques and limitations
    • Funck-Bretano C, Jaillon P: Rate-corrected QT interval: techniques and limitations. Am J Cardiol 1993;72:17B-22B.
    • (1993) Am J Cardiol , vol.72
    • Funck-Bretano, C.1    Jaillon, P.2
  • 8
    • 0001127258 scopus 로고
    • An analysis of time-relations of electrocardiograms
    • Bazett HC: An analysis of time-relations of electrocardiograms. Heart 1920;7:353.
    • (1920) Heart , vol.7 , pp. 353
    • Bazett, H.C.1
  • 9
    • 84980098899 scopus 로고
    • Die systolendauer im elektrokardiogramm bei normalen menschen und bei herzkranken
    • Fridericia LS: Die systolendauer im elektrokardiogramm bei normalen menschen und bei herzkranken. Acta Med Scand 1920;53:469.
    • (1920) Acta Med Scand , vol.53 , pp. 469
    • Fridericia, L.S.1
  • 10
    • 0028358346 scopus 로고
    • Relation between QT intervals and heart rates from 40 to 120 beats/min in rest electrocardiograms of men and a simple method to adjust QT interval values
    • Karjalainen J, Viitasalo M, Manttari M, Manninen V: Relation between QT intervals and heart rates from 40 to 120 beats/min in rest electrocardiograms of men and a simple method to adjust QT interval values. J Am Coll Cardiol 1994;23:1547-1553.
    • (1994) J Am Coll Cardiol , vol.23 , pp. 1547-1553
    • Karjalainen, J.1    Viitasalo, M.2    Manttari, M.3    Manninen, V.4
  • 11
    • 0027326837 scopus 로고
    • QT interval: A measure of drug action
    • Woosley R, Sale M: QT interval: a measure of drug action. Am J Cardiol 1993;72:36B-43B.
    • (1993) Am J Cardiol , vol.72
    • Woosley, R.1    Sale, M.2
  • 12
    • 0013545440 scopus 로고
    • Seven treacherous pitfalls in statistics, illustrated
    • Weitzman RA: Seven treacherous pitfalls in statistics, illustrated. Psychol Rep 1984;54:355-356.
    • (1984) Psychol Rep , vol.54 , pp. 355-356
    • Weitzman, R.A.1
  • 13
    • 0000758303 scopus 로고
    • If the null hypothesis is impossible, why test for it?
    • Murphy KR: If the null hypothesis is impossible, why test for it? Amer Psychol 1990;45:403-404.
    • (1990) Amer Psychol , vol.45 , pp. 403-404
    • Murphy, K.R.1
  • 14
    • 0028855801 scopus 로고
    • Accepting the null hypothesis
    • Frick RW: Accepting the null hypothesis. Memory & Cognition 1995;23:132-138.
    • (1995) Memory & Cognition , vol.23 , pp. 132-138
    • Frick, R.W.1
  • 15
    • 0018484431 scopus 로고
    • When can "non-significantly different" treatments be considered as "equivalent."
    • Spriet A, Beiler D: When can "non-significantly different" treatments be considered as "equivalent." Br J Clin Pharmacol 1979;7:623-624.
    • (1979) Br J Clin Pharmacol , vol.7 , pp. 623-624
    • Spriet, A.1    Beiler, D.2
  • 16
    • 0018076475 scopus 로고
    • The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial: Survey of 71 "negative" trials
    • Freiman JA, Chalmers TC, Smith H, Kuebler RR: The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial: survey of 71 "negative" trials. New Eng J Med 1978;299:690-694.
    • (1978) New Eng J Med , vol.299 , pp. 690-694
    • Freiman, J.A.1    Chalmers, T.C.2    Smith, H.3    Kuebler, R.R.4
  • 17
    • 0022371344 scopus 로고
    • Beta, or type II error in psychiatric controlled clinical trials
    • Edlund MJ, Overall JE, Rhoades H: Beta, or type II error in psychiatric controlled clinical trials. J Psych Res 1985;19:563-567.
    • (1985) J Psych Res , vol.19 , pp. 563-567
    • Edlund, M.J.1    Overall, J.E.2    Rhoades, H.3
  • 18
    • 0022710709 scopus 로고
    • A proposal for interpreting and reporting negative studies
    • Hauck WH, Anderson S: A proposal for interpreting and reporting negative studies. Stat Med 1986;5:203-209.
    • (1986) Stat Med , vol.5 , pp. 203-209
    • Hauck, W.H.1    Anderson, S.2
  • 19
    • 0013522130 scopus 로고    scopus 로고
    • European Agency for the Evaluation of Medicinal Products (EMEA): Committee for Proprietary Medicinal Products (CPMP) (1997): The assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products
    • European Agency for the Evaluation of Medicinal Products (EMEA): Committee for Proprietary Medicinal Products (CPMP) (1997): The assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products.
  • 20
    • 0027197984 scopus 로고
    • How to measure the QT interval: What is normal?
    • Carson A: How to measure the QT interval: what is normal? Am J Cardiol 1993;72:14B-16B.
    • (1993) Am J Cardiol , vol.72
    • Garson, A.1
  • 21
    • 0025825919 scopus 로고
    • Variability of the QT measurement in healthy men, with implications for selection of an abnormal QT value to predict drug toxicity and proarrhythmia
    • Morganroth J, Brozovich FV, McDonald JT, Jacobs RA: Variability of the QT measurement in healthy men, with implications for selection of an abnormal QT value to predict drug toxicity and proarrhythmia. Am J Cardiol 1991;67:774-776.
    • (1991) Am J Cardiol , vol.67 , pp. 774-776
    • Morganroth, J.1    Brozovich, F.V.2    McDonald, J.T.3    Jacobs, R.A.4
  • 22
    • 0025221958 scopus 로고
    • Covariation and reliability of ECG parameters during 24 hour monitoring
    • Myrtek M: Covariation and reliability of ECG parameters during 24 hour monitoring. Int J Psychophysiol 1990;10:117-123.
    • (1990) Int J Psychophysiol , vol.10 , pp. 117-123
    • Myrtek, M.1
  • 23
    • 0013513817 scopus 로고
    • Aptech systems I
    • Kent, WA: Aptech Systems
    • Aptech Systems I: GAUSS System, Version 3.2. Kent, WA: Aptech Systems, 1995.
    • (1995) GAUSS System, Version 3.2
  • 26
    • 0030058329 scopus 로고    scopus 로고
    • Dirunal pattern of QTc interval: How long is prolonged? Possible relation to circadian triggers of cardiovascular events
    • Molnar J, Zhang F, Weiss J, Ehlert FA, Rosenthal JE: Dirunal pattern of QTc interval: how long is prolonged? Possible relation to circadian triggers of cardiovascular events. J Am Coll Cardiol 1996;27:76-83.
    • (1996) J Am Coll Cardiol , vol.27 , pp. 76-83
    • Molnar, J.1    Zhang, F.2    Weiss, J.3    Ehlert, F.A.4    Rosenthal, J.E.5
  • 27
    • 0027052236 scopus 로고
    • Optimum numerical integration methods for area-under-the-curve (AUC) and area-under-the-moment-curve (AUMC)
    • Purves RD: Optimum numerical integration methods for area-under-the-curve (AUC) and area-under-the-moment-curve (AUMC). J Pharmacokin Biopharm 1992;20:211-226.
    • (1992) J Pharmacokin Biopharm , vol.20 , pp. 211-226
    • Purves, R.D.1
  • 28
    • 0021061991 scopus 로고
    • How much of the placebo "effect" is really statistical regression?
    • McDonald CJ, Mazzuca SA, McCabe GP: How much of the placebo "effect" is really statistical regression? Stat Med 1983;2:417-427.
    • (1983) Stat Med , vol.2 , pp. 417-427
    • McDonald, C.J.1    Mazzuca, S.A.2    McCabe, G.P.3
  • 29
    • 0017173907 scopus 로고
    • The effect of regression to the mean in epidemiologic and clinical studies
    • Davis CE: The effect of regression to the mean in epidemiologic and clinical studies. Am J Epid 1976;104:493-498.
    • (1976) Am J Epid , vol.104 , pp. 493-498
    • Davis, C.E.1
  • 30
    • 0019475701 scopus 로고
    • Reliability of blood pressure measurements: Implications for designing and evaluating programs to control hypertension
    • Shepard DS: Reliability of blood pressure measurements: implications for designing and evaluating programs to control hypertension. J Chron Dis 1981;34:191-209.
    • (1981) J Chron Dis , vol.34 , pp. 191-209
    • Shepard, D.S.1
  • 31
    • 0025130208 scopus 로고
    • Baseline comparability in clinical trials: Prevention of "poststudy anxiety."
    • Enas GG, Enas NH, Spradlin CT, Wilson MG, Wiltse CG: Baseline comparability in clinical trials: prevention of "poststudy anxiety." Drug Info J 1990;24:541-548.
    • (1990) Drug Info J , vol.24 , pp. 541-548
    • Enas, G.G.1    Enas, N.H.2    Spradlin, C.T.3    Wilson, M.G.4    Wiltse, C.G.5
  • 32
    • 0028101076 scopus 로고
    • Testing for baseline differences in clinical trials
    • Senn S: Testing for baseline differences in clinical trials. Stat Med 1994;13:1715-1726.
    • (1994) Stat Med , vol.13 , pp. 1715-1726
    • Senn, S.1
  • 34
    • 0030831433 scopus 로고    scopus 로고
    • An example of using mixed models and PROC MIXED for longitudinal data
    • Wolfinger RD: An example of using mixed models and PROC MIXED for longitudinal data. J Biopharm Stat 1997;7:481-500.
    • (1997) J Biopharm Stat , vol.7 , pp. 481-500
    • Wolfinger, R.D.1
  • 35
  • 36
    • 0019785890 scopus 로고
    • Understanding the dose-effect relationship: Clinical application of pharmacokinetic-pharmacodynamic models
    • Holford NHG, Sheiner LB: Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clin Pharmacokin 1981;6:429-453.
    • (1981) Clin Pharmacokin , vol.6 , pp. 429-453
    • Holford, N.H.G.1    Sheiner, L.B.2
  • 37
    • 0030026158 scopus 로고    scopus 로고
    • Standards for ECGs in clinical trials
    • Goodman DB: Standards for ECGs in clinical trials. Drug Info J 1996;30:237-242.
    • (1996) Drug Info J , vol.30 , pp. 237-242
    • Goodman, D.B.1


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