A rational approach to the planning and analysis of electrocardiogram safety data in clinical trials

International Journal of Pharmaceutical Medicine

Volumn 16, Issue 3, 2002, Pages 133-140

  Steare, S E ^a   Morganroth, J ^b  

^a Bayer plc UK   (United Kingdom)

^b University of Philadelphia   (United States)

Author keywords

Cardiac safety; Clinical trials; Electrocardiogram; QTc interval prolongation

Indexed keywords

ARTICLE; CLINICAL RESEARCH; COMORBIDITY; DIAGNOSTIC ACCURACY; ELECTROCARDIOGRAM; HEART INFARCTION; HEART LEFT VENTRICLE HYPERTROPHY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QT INTERVAL; REGULATORY MECHANISM; SIGNAL NOISE RATIO; STATISTICAL ANALYSIS;

EID: 0036622648     PISSN: 13649027     EISSN: None     Source Type: Journal    
DOI: 10.1097/00124363-200206000-00005     Document Type: Article

References (12)

1. CPMP Points to Consider: The assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products. London: EMEA; December 1997.
2. De Bacquer D, De Backer G, Kornitzer M. Prevalences of ECG findings in large population based samples of men and women, Heart 2000; 84:625-633.
3. Mansi IA, Nash IS. Ethnic differences in the ST segment of the electrocardiogram: A comparative study among six ethnic groups. Am J Emerg Med 2001; 19:541-544.
4. Berkin KE, Ball SG. Essential hypertension: the heart and hypertension. Heart 2000; 86:467-475.
5. The Joint European Society of Cardiology/American College of Cardiology Committee. Myocardial infarction redefined - A consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. Eur Heart J 2000; 21:1502-1513.
6. De Ponti F, Poluzzi E, Montanaro N. Organising evidence on QT prolongation and occurrence of Torsade de Pointes with non-antiarrhythmic drugs: a call for a consensus. Eur J Clin Pharmacol 2001; 57:185-209.
7. Morganroth J. Focus on issues in measuring and interpreting changes in the QT interval duration. Eur Heart J 2001; 3:K105-K111.
8. Gunput MD, Williams P, Yogendran L, Keene ON, Maconchie JG. QTc, PR interval and heart rate variability in healthy volunteers: a review of 12 lead ECG data from clinical pharmacology studies. Br J Clin Pharmacol 1994; 39:P577-P578.
9. Montgomery H, Hunter S, Morris S, Naunton-Morgan R, Marshall RH. Interpretation of electrocardiograms by doctors. Br Med J 1994; 309:1551-1552.
10. Haverkamp W, Breithardt G, Camm AJ, Janse MJ, Rosen MR, Antzelevitch C, et al. The potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs: clinical and regulatory implications. Report on a policy conference of the European Society of Cardiology. Eur Heart J 2000; 21:1216-1231.
11. Peterson R. Therapeutic Products Directorate Guidance Document (Draft). Ottawa: Health Canada; March 2001.
12. Moss AJ, Zareba W, Benhorin J, Malik M, Couderc J-P, Kennedy H, et al. ISHNE Guidelines for the Electrocardiographic Evaluation of Drug-related QT Prolongation and Other Alterations in Ventricular Repolarisation: Task Force Summary. Ann Noninvasive Electrocardiol 2001; 6:333-341.