QT analysis: A complex answer to a 'simple' problem

Statistics in Medicine

Volumn 23, Issue 17, 2004, Pages 2625-2643

  Li, Lang ^a   Desai, Mehul ^a   Desta, Zeruesenay ^a   Flockhart, David ^a  

^a INDIANA UNIVERSITY   (United States)

Author keywords

Linear mixed model; QT; Restricted maximum likelihood estimate

Indexed keywords

HALOPERIDOL; PLACEBO;

ADULT; ANALYTICAL ERROR; ARTICLE; CALCULATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEVICE; DOUBLE BLIND PROCEDURE; ELECTROCARDIOGRAPHY; FEMALE; HEART ARRHYTHMIA; HEART RATE; HUMAN; HUMAN EXPERIMENT; MALE; MATHEMATICAL COMPUTING; QT INTERVAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RR INTERVAL; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE;

ADULT; ANTIPSYCHOTIC AGENTS; ARRHYTHMIA; BIOLOGICAL MARKERS; COMPUTER SIMULATION; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; ELECTROCARDIOGRAPHY; FEMALE; HALOPERIDOL; HEART RATE; HUMANS; MALE; MODELS, CARDIOVASCULAR; MODELS, STATISTICAL; RANDOMIZED CONTROLLED TRIALS;

EID: 4444256528     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1863     Document Type: Article

References (16)

1. www.torsades.org, 03/04/2004.
2. Desai M, Tanus-Santos J, Li L, Gorski JC, Arefayene M, Liu Y, Desta Z, Flockhart D. Pharmacokinetics and QT interval pharmacodynamics of oral halporeridol in poor and extensive metabolizers of CYP2D6. The Pharmacogenomic Journal 2003; 3(2):105-113.
3. Bazett JC. An analysis of time relations of electrocardiograms. Heart 1920; 7:353-367.
4. Fridericia LS. Die Systolendauer im Elekrokardiogramm bei normalen Menschen und bei Herzkranken. Acta Medica Scandinavica 1920; 53:469-486.
5. Malik M. Problems of heart rate correction in assessment of drug-induced QT interval prolongation. Journal of Cardiovascular Electrophysiology 2001; 12:411-420.
6. Searle SR, Casella G, McCulloch CE. Variance Components. Wiley: New York, 1992.
7. Davidian M, Giltinan DG. Nonlinear Models for Repeated Measurement Data. Chapman & Hall: London, 1995.
8. Desai M, Li L, Desta Z, Malik M, Flockhart D. Variability of heart rate correction methods for the QT interval: potential for QTc overestimation with a low dose of haloperidol. British Journal of Clinical Pharmacology 2003; 55(6):511-517.
9. Carroll RJ, Ruppert D. Transformation and Weighting in Regression. Chapman & Hall: New York, 1988.
10. Harville D. Maximum likelihood approaches to variance component estimation and to related problems. Journal of the American Statistical Association 1977; 72:320-340.
11. Davidian M, Carroll RJ. Variance function estimation. Journal of the American Statistical Association 1987; 82:1079-1091.
12. Mayuga KA, Parker M, Sukthanker ND, Perlowski A, Schwartz JB, Kadish AH. Effects of age and gender on the QT response to exercise. American Journal of Cardiology 2001; 87:163-167.
13. Benton RE, Sale M, Flockhart DA, Woosley RL. Greater quinidine-induced QTc interval prolongation in women. Clinical Pharmacology and Therapeutics 2000; 67:413-418.
14. Laired NM, Ware JH. Random effects models for longitudinal data. Biometrics 1982; 38:963-974.
15. Lehmann EL. Theory of Point Estimation. Chapman & Hall: London, 1986.
16. www.fda.gov/cder/calendar/meeting/qt4jam.pdf. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. 10/20/2003.