Long-term hepatic safety of ambrisentan in patients with pulmonary arterial hypertension

Journal of the American College of Cardiology

Volumn 60, Issue 1, 2012, Pages 80-81

  Ben Yehuda, Ori ^a   Pizzuti, David ^b   Brown, Andrea ^b   Littman, Marcus ^b   Gillies, Hunter ^b   Henig, Noreen ^b   Peschel, Tobias ^b  

^a GILEAD SCIENCES   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; AMBRISENTAN; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; BOSENTAN; ENDOTHELIN RECEPTOR ANTAGONIST; PLACEBO; SITAXSENTAN;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; DISEASE ASSOCIATION; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; LETTER; LIVER CELL DAMAGE; LIVER DISEASE; LIVER FUNCTION TEST; LIVER TOXICITY; PATIENT MONITORING; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PULMONARY HYPERTENSION; TREATMENT DURATION; TREATMENT RESPONSE;

ADULT; AGED; ALANINE TRANSAMINASE; ANTIHYPERTENSIVE AGENTS; ASPARTATE AMINOTRANSFERASES; DRUG ADMINISTRATION SCHEDULE; DRUG-INDUCED LIVER INJURY; ENDOTHELINS; FEMALE; HUMANS; HYPERTENSION, PULMONARY; INCIDENCE; LIVER; LIVER FUNCTION TESTS; MALE; MIDDLE AGED; PHENYLPROPIONATES; PYRIDAZINES; RECEPTOR, ENDOTHELIN A; RISK FACTORS; UNITED STATES;

EID: 84862896499     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2012.03.025     Document Type: Letter

References (6)

1. V.J. Navarro, J.R. Senior Drug-related hepatotoxicity N Engl J Med 354 2006 731 739
2. FDA Medical Review of Efficacy (Bosentan) NDA #21,290 June 29, 2001 http://www.fda.gov/ohrms/dockets/ac/01/briefing/3775b2-04-efficacy.pdf Accessed November 11, 2011
3. R. Temple Hy's law: predicting serious hepatotoxicity Pharmacoepidemiol Drug Saf 15 2006 241 243
4. R.J. Barst, D. Langleben, D. Badesch STRIDE-2 Study Group Treatment of pulmonary arterial hypertension with the selective endothelin-A receptor antagonist sitaxsentan J Am Coll Cardiol 47 2006 2049 2056
5. M. Lazo, E. Selvin, J.M. Clark Brief communication: clinical implications of short-term variability in liver function test results Ann Intern Med 148 2008 348 352
6. J. Hartman, K. Brouwer, A. Mandagere, L. Melvin, R. Gorczynski Evaluation of the endothelin receptor antagonists ambrisentan, darusentan, bosentan, and sitaxsentan as substrates and inhibitors of hepatobiliary transporters in sandwich-cultured human hepatocytes Can J Physiol Pharmacol 88 2010 682 691