Clinical observation of liver chemistry abnormalities in asthmatics.
OBJECTIVE
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.
Katz
David A
DA
Abbott Laboratories, Abbott Park, IL 60064, USA. david.katz@abbott.com
Isaacson
Jeffrey D
JD
Han
Lixin
L
Drajesk
Jeffrey F
JF
Comer
Gail M
GM
Heath-Chiozzi
Margo E
ME
D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood*; D000469:Alkaline Phosphatase / Q000097:blood; D018927:Anti-Asthmatic Agents / Q000009:adverse effects*; D001219:Aspartate Aminotransferases / Q000097:blood; D001249:Asthma / Q000188:drug therapy*; D001663:Bilirubin / Q000097:blood; D015415:Biomarkers / Q000097:blood; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis* / Q000209:etiology; D005260:Female; D006801:Humans; D008099:Liver / Q000737:chemistry* / Q000187:drug effects / Q000201:enzymology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D013997:Time Factors; D055815:Young Adult; D005723:gamma-Glutamyltransferase / Q000097:blood
D018927:Anti-Asthmatic Agents; D015415:Biomarkers; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D001663:Bilirubin