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Current Drug Safety


ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Clinical Observation of Liver Chemistry Abnormalities in Asthmatics

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

Volume 4, Issue 3, 2009

Page: [173 - 180] Pages: 8

DOI: 10.2174/157488609789006930

Price: $65


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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