Electrocardiogram Reference Ranges Derived from a Standardized Clinical Trial Population
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Aloxoi A. Dmitrioh, PbD Eli Lilly and Company, Indianapdis, Indiana Grqory D. Sidos, I D Eli Lilly and Company, Indianapdis, Indiana
INTERVAL PROLONGATION
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Electrocardiogram Reference Ranges Derived From a Standardized Clinical Trial Population
K o n ~ t b1. Wintrs, I D Eli Lilly and Company, Indianapdis, Indiana Rlcbard 1. KOVKS, MD Kmnnnt Institute of Curdidogy, Department of Medicine, Indiana University S c h d of Medicine, Indianapdis, Indiana Dawn M. Robbum, BS Eli Lilly and Company, Indianapdis, Indiana
Jobi C. Bloom, DVM, PbD Eli Lilly and Company, Indianapdis, Indiana William Grob, MD Kmnnnt Institute of Cardidogy, Department of Medicine, Indiana University S c h d of Medicine, Indianapdis, Indiana Paul R. Eisoaborg, MD Eli Lilly and Company, Indianapdis, Indiana
Koy Words Electrocardiograms; Reference mngs; Clinical trials; QT interval Corrospondonco Addross Alan' Dmiirimko, filly Rseurch Labomton's, Eli Lilly and Company, Lilb Corpomte Cmter, Indianapdis, IN 46285 (nail: Dmitrimko,4lcx@lillycorn).
INTRODUCTION A large number of publications focus on the
derivation of normal limits for QT interval and other ECG parameters (1-5). Macfarlane and Lawie (1)and Sagie et al. (2) reported the results of two studies conducted in Glasgow, Scotland, and Framingham, Massachusetts. The analysis sample in the Glasgow study consisted of 1,338 subjects between the ages of 16 and 64. The analysis was based on 12-lead electrocardiograms (ECGs) with all parameters measured using a computer algorithm. In the Framingham study, 12-lead ECGs were obtained from 5,209 subjects between the ages of 28 and 62 years. ECG parameters were measured manually by two readers. The two studies described are fairly representative of the majority of community-based studies found in the literature in which it is common to develop normal limits for numerical ECG parameters from relatively small samplesof healthy subjects. In these studies, every attempt is made to ensure that the chosen population is homogeneous and represents a "normal" population of subjects without ECG abnormalities. For example, more than 100 subjects (2%) with coronary heart disease, very low heart rates, or very high heart rates were excluded from the analysis in the Framingham study. Similarly, children
with known cardiovascular abnormalities were excluded in the study summarized in Rijnbeek et al. (3). Rautahaju et al. (4) summarizedthe results of one of the most comprehensive ECG studies conducted in North America. The analysis sample consisted of 14,379 children and adults ranging in age from birth to 75 years. The study emphasized that the sample was created by excluding primary ECG abnormalities known to affect the duration of QT interval. Criteria such as these are unlikely to produce samples of subjects representative of patient populations typically seen in either clinical trials or clinical practice. Computer-based measurement of heart rate and PR QRS, and QT interval duration from 12lead resting ECGs is becoming popular in the pharmaceutical industry
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