Analysis of Relationship between Levofloxacin and Corrected QT Prolongation Using a Clinical Data Warehouse.
- Author:
Man Young PARK
1
;
Eun Yeob KIM
;
Young Ho LEE
;
Woojae KIM
;
Ku Sang KIM
;
Seung Soo SHEEN
;
Hong Seok LIM
;
Rae Woong PARK
Author Information
- Publication Type:Original Article
- Keywords: Long QT Syndrome; Ofloxacin; Data Mining; Product Surveillance; Post-marketing; Hospital Information Systems
- MeSH: Body Temperature; Data Mining; Drug Toxicity; Electrocardiography; Electronic Prescribing; Electronics; Electrons; Hospital Information Systems; Hospitalization; Humans; Long QT Syndrome; Ofloxacin; Smoking
- From:Healthcare Informatics Research 2011;17(1):58-66
- CountryRepublic of Korea
- Language:English
- Abstract: OBJECTIVE: The aim of this study was to examine whether or not levofloxacin has any relationship with QT prolongation in a real clinical setting by analyzing a clinical data warehouse of data collected from different hospital information systems. METHODS: Electronic prescription data and medical charts from 3 different hospitals spanning the past 9 years were reviewed, and a clinical data warehouse was constructed. Patients who were both administrated levofloxacin and given electrocardiograms (ECG) were selected. The correlations between various patient characteristics, concomitant drugs, corrected QT (QTc) prolongation, and the interval difference in QTc before and after levofloxacin administration were analyzed. RESULTS: A total of 2,176 patients from 3 different hospitals were included in the study. QTc prolongation was found in 364 patients (16.7%). The study revealed that age (OR 1.026, p < 0.001), gender (OR 0.676, p = 0.007), body temperature (OR 1.267, p = 0.024), and cigarette smoking (OR 1.641, p = 0.022) were related with QTc prolongation. After adjusting for related factors, 12 drugs concomitant with levofloxacin were associated with QTc prolongation. For patients who took ECGs before and after administration of levofloxacin during their hospitalization (n = 112), there was no significant difference in QTc prolongation. CONCLUSIONS: The age, gender, body temperature, cigarette smoking and various concomitant drugs might be related with QTc prolongation. However, there was no definite causal relationship or interaction between levofloxacin and QTc prolongation. Alternative surveillance methods utilizing the massive accumulation of electronic medical data seem to be essential to adverse drug reaction surveillance in future.