An integrated analysis of liver safety data from orlistat clinical trials

Obesity Facts

Volumn 5, Issue 4, 2012, Pages 485-494

  Morris, Marc ^a   Lane, Peter ^a   Lee, Kwan ^a   Parks, Daniel ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

Drug toxicity; Epidemiology; Meta analysis; Obesity management; Pharmacological therapy

Indexed keywords

PLACEBO; TETRAHYDROLIPSTATIN;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BILIRUBIN BLOOD LEVEL; DRUG INFORMATION; DRUG SAFETY; HUMAN; LIVER FUNCTION TEST; LIVER INJURY; LOW CALORY DIET; META ANALYSIS; OBESITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW;

ALANINE TRANSAMINASE; ANTI-OBESITY AGENTS; BILIRUBIN; HUMANS; KAPLAN-MEIER ESTIMATE; LACTONES; LIVER; OBESITY; ODDS RATIO;

EID: 84864416628     PISSN: 16624025     EISSN: 16624033     Source Type: Journal    
DOI: 10.1159/000341589     Document Type: Article

References (18)

1. Temple RJ, Himmel MH: Safety of newly approved drugs: implications for prescribing. JAMA 2002; 287: 2273-2275.
2. US Food and Drug Administration: Questions and Answers: Orlistat and Severe Liver Injury. www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm213040.htm.
3. Zhi J, Mulligan TE, Hauptman JB: Long-term systemic exposure of orlistat a lipase inhibitor and its metabolites in obese people. J Clin Pharmacol 1999; 39: 41-46.
4. Lee WM, Senior JR: Recognizing drug-induced liver injury: current problems, possible solutions. Toxicol Pathol 2005; 33: 155-164.
5. Lee WM: Acute liver failure in the united states. Semin Liver Dis 2003; 23: 217-226.
6. Chitturi S, Farrell GC: Etiopathogenesis of non-alcoholic steatohepatitis. Semin Liver Dis 2001; 21: 27-41.
7. El-Serag HB, Everhart JE: Diabetes increases the risk of acute hepatic failure. Gastroenterology 2002; 122: 1822-1828.
8. Harrison SA, Fecht W, Brunt EM, Neuschwander-Tetri BA: Orlistat for overweight subjects with non-alcoholic steatohepatitis: a randomized prospective trial. Hepatology 2009; 49: 80-86.
9. Shapiro MA, Lewis JH: Causality assessment of drug-induced hepatotoxicity: promises and pitfalls. Clin Liver Dis 2007; 11: 477-505.
10. Sutton AJ, Cooper NJ, Lambert PC, Jones DR, Abrams KR, Sweeting MJ: Meta-analysis of rare and adverse event data. Expert Rev Pharmacoecon Outcomes Res 2002; 2: 367-379.
11. Zimmerman HJ: The spectrum of hepatotoxicity. Perspect Biol Med 1968; 12: 135-161.
12. Guo T, Gelperin K, Senior J: A tool to help you decide (detect potentially serious liver injury). 2008. www.fda. gov/downloads/Drugs/ ScienceResearch/ResearchAreas/ucm076777.pdf.
13. Cai Z, Christianson M, Stahle L, Keisu M: Reexamining transaminase elevation in Phase I clinical trials: the importance of baseline and change from baseline. Eur J Clin Parmacol 2009; 65: 1025-1035.
14. Chuang-Stein C: The regression fallacy . Drug Inform J 1993; 27: 1213-1220.
15. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations . JAm StatistAssoc 1958; 53: 457-481.
16. Lane PW, Nelder JA: Analysis of covariance and standardization as instances of prediction . Biometrics 1980; 38: 613-621.
17. Breslow NE, Cain KC: Logistic regression for two-stage case-control data. Biometrika 1998; 75: 11-20.
18. Borenstein M, Hedges LV, Higgins JPT, Rothstein HR. Introduction to Meta-Analysis. Chichester, John Wiley & Sons Ltd., 2009.