title: Clinical observation of liver chemistry abnormalities in asthmatics.
abstract: 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.
authors.affiliation: Abbott Laboratories, Abbott Park, IL 60064, USA. david.katz@abbott.com
authors.forename: David A
authors.initials: DA
authors.lastname: Katz
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Isaacson
authors.forename: Lixin
authors.initials: L
authors.lastname: Han
authors.forename: Jeffrey F
authors.initials: JF
authors.lastname: Drajesk
authors.forename: Gail M
authors.initials: GM
authors.lastname: Comer
authors.forename: Margo E
authors.initials: ME
authors.lastname: Heath-Chiozzi
mesh_terms: 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
chemical_list: D018927:Anti-Asthmatic Agents; D015415:Biomarkers; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D001663:Bilirubin