Clinical Observation of Liver Chemistry Abnormalities in Asthmatics

Author(s): David A. Katz, Jeffrey D. Isaacson, Lixin Han, Jeffrey F. Drajesk, Gail M. Comer, Margo E. Heath-Chiozzi

Journal Name: Current Drug Safety

Volume 4 , Issue 3 , 2009

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Objectives: Describe the population characteristics of liver chemistries, the incidence and patterns of liver chemistry abnormalities, and the longitudinal behavior of alanine aminotransferase in mild-to-moderate asthmatic patients. Methods: We undertook a retrospective analysis of comparator arm data from a long-term safety surveillance study of a leukotriene inhibitor. Results: Several liver chemistry elevations relative to the upper limit of normal were observed. We identified three other types of outliers: liver chemistry elevations relative to screening values, persistent liver chemistry elevations, and unusually variable alanine aminotranferase. Conclusions: In the absence of any common drug therapy, there are considerable within-population differences of liver chemistry profiles including substantial outliers. This ordinary variability should be taken into account in the design of clinical trials and analysis of drug-induced liver injury therein.

Keywords: Alanine aminotransferase, aspartate aminotransferase, bilirubin, alkaline phosphatase, gamma-glutaminyl transferase, observational study

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Article Details

Year: 2009
Page: [173 - 180]
Pages: 8
DOI: 10.2174/157488609789006930
Price: $65

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