Abstract
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
Current Drug Safety
Title: Clinical Observation of Liver Chemistry Abnormalities in Asthmatics
Volume: 4 Issue: 3
Author(s): David A. Katz, Jeffrey D. Isaacson, Lixin Han, Jeffrey F. Drajesk, Gail M. Comer and Margo E. Heath-Chiozzi
Affiliation:
Keywords: Alanine aminotransferase, aspartate aminotransferase, bilirubin, alkaline phosphatase, gamma-glutaminyl transferase, observational study
Abstract: 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.
Export Options
About this article
Cite this article as:
Katz A. David, Isaacson D. Jeffrey, Han Lixin, Drajesk F. Jeffrey, Comer M. Gail and Heath-Chiozzi E. Margo, Clinical Observation of Liver Chemistry Abnormalities in Asthmatics, Current Drug Safety 2009; 4 (3) . https://dx.doi.org/10.2174/157488609789006930
DOI https://dx.doi.org/10.2174/157488609789006930 |
Print ISSN 1574-8863 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3911 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
Editorial from Guest Editors [Hot Topic: Viral Bronchiolitis: The Year in Review (Guest Editors: Louis Bont and Jan Kimpen)]
Current Respiratory Medicine Reviews Nanotechnology and Alzheimer's Disease: What has been Done and What to Do'
Current Medicinal Chemistry Tako-tsubo Cardiomyopathy: A Review of the Literature
Current Cardiology Reviews Antihyperglycemic and Antidyslipidemic Activities of the <i>Aqueous Salvia hispanica</i> Extract in Diabetic Rat
Cardiovascular & Hematological Agents in Medicinal Chemistry Flavonoids: Prospective Drug Candidates
Mini-Reviews in Medicinal Chemistry Detection of Ventricular Arrhythmias using HRV Analysis and Quadratic Features
Recent Advances in Electrical & Electronic Engineering Long Term Treatment with Tetradecylthioacetic Acid Improves the Antioxidant Status in Obese Zucker (fa/fa) Rats
Drug Metabolism Letters Biologic Therapy in Psoriasis: Safety Profile
Current Drug Safety Effects of Tea Catechins on Inflammation-Related Cardiovascular Diseases
Current Immunology Reviews (Discontinued) Random Walks on Biomedical Networks
Current Proteomics Dietary Small Molecules and Large-Scale Gene Expression Studies: An Experimental Approach for Understanding their Beneficial Effects on the Development of Malignant and Non-Malignant Proliferative Diseases
Current Medicinal Chemistry Use of Biguanides and the Risk of Colorectal Cancer: A Register-Based Cohort Study
Current Drug Safety Biomarkers of Atrial Fibrillation in Hypertension
Current Medicinal Chemistry Sex Steroid Hormone Effects in Normal and Pathologic Conditions in Lung Physiology
Mini-Reviews in Medicinal Chemistry Lifestyle Changes and Pharmacological Risk Factor Modification for Effective Vascular Disease Prevention
Vascular Disease Prevention (Discontinued) Recent Advances and Patents on Novel Devices for Minimally Invasive Treatment of Functional Mitral Regurgitation
Recent Patents on Biomedical Engineering (Discontinued) Stem Cells Differentiation: Organic Chemistry is Back
Letters in Organic Chemistry Targeted Therapy Options for Treatment of Bone Metastases; Beyond Bisphosphonates
Current Pharmaceutical Design High Density Lipoprotein Cholesterol and Statin Trials
Current Medicinal Chemistry Vascular microRNAs
Current Drug Targets