The influence of renal function on hydroxyurea pharmacokinetics in adults with sickle cell disease

Journal of Clinical Pharmacology

Volumn 45, Issue 4, 2005, Pages 434-445

  Yan, Jing He ^a,d   Ataga, Kenneth ^b   Kaul, Sanjeev ^a   Olson, Jeffery S ^a   Grasela, Dennis M ^a   Gothelf, Samantha ^a   Kutlar, Abdulah ^c   Orringer, Eugene ^b  

^a BRISTOL MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

^c MEDICAL COLLEGE OF GEORGIA   (United States)

^d BRISTOL MYERS SQUIBB   (United States)

Author keywords

Hydroxyurea; Renal function; Sickle cell disease

Indexed keywords

DROXIA; HYDROXYUREA;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; DISEASE COURSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DOSE REGIMEN; DRUG METABOLISM; DRUG SAFETY; DRUG URINE LEVEL; FEMALE; HEMODIALYSIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; KIDNEY FAILURE; KIDNEY FUNCTION; MALE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; SICKLE CELL ANEMIA; SIDE EFFECT;

ADULT; AGED; ANEMIA, SICKLE CELL; FEMALE; HUMANS; HYDROXYUREA; KIDNEY; KIDNEY FAILURE, CHRONIC; KIDNEY FUNCTION TESTS; MALE; MIDDLE AGED;

EID: 16844362802     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270004273526     Document Type: Article

References (26)

1. Bunn HF. Pathogenesis and treatment of sickle cell disease. N Engl J Med. 1997;337:762-769.
2. Steinberg MH. Management of sickle cell disease. N Engl J Med. 1999;340:1021-1030.
3. Hebbel RP, Boogaerts MAB, Eaton JW, Steinberg MH. Erythrocyte adherence to endothelium in sickle cell anemia: a possible determinant of disease severity. N Engl J Med. 1980;302:992-995.
4. Platt OS, Thorington BD, Brambilla DJ, et al. Pain in sickle cell disease: rates and risk factors. N Engl J Med. 1991;325:11-16.
5. Platt OS, Brambilla DJ, Rosse WF, et al. Mortality in sickle cell disease: life expectancy and risk factors for early death. N Engl J Med. 1994;330:1639-1644.
6. Charache S, Terrin ML, Moore RD, et al. Effect of hydroxyurea on the frequency of painful crises in sickle cell anemia. N Engl J Med. 1995;332:1317-1322.
7. Ferster A, Vermylen C, Cornu G, et al. Hydroxyurea for treatment of severe sickle cell anemia: a pediatric clinical trial. Blood. 1996;88: 1960-1964.
8. Steinberg MH, Barton F, Castro O, et al. Effect of hydroxyurea on mortality and morbidity in sickle cell anemia: risks and benefits up to 9 years of treatment. JAMA. In press.
9. Thelander L, Reichard P. Reduction of ribonucleotides. Ann Rev Biochem. 1979;48:133.
10. Charache S, Barton FB, Moore RD, et al. Hydroxyurea and sickle cell anemia: clinical utility of a myelosuppressive "switching" agent: the Multicenter Study of Hydroxyurea in Sickle Cell Anemia. Medicine (Baltimore). 1996;75:300-326.
11. Ataga KI, Orringer EP. Renal abnormalities in sickle cell disease. Am J Hematol. 2000;63:205-211.
12. Rodriguez GI, Kuhn JG, Weiss GR, et al. A bioavailability and pharmacokinetic study of oral and intravenous hydroxyurea. Blood. 1998;91:1533-1541.
13. Dodds, MG, Vicini P. Definition and classification of stages of chronic kidney disease. Am J Kidney Dis. 2002;39(suppl):46-75.
14. Statistical Analysis Systems (SAS), Version 6.12. Gary, NC: SAS Institute; 1997.
15. Charache S. Hydroxyurea: Effects on hemoglobin F production in patients with sickle cell anemia. Blood. 1992;79:2555-2565.
16. Droxia NDA 16-295, supplement S029, Apr 25, 1997, Appendices A, B, and C, BMS document in file.
17. WinNonlin, Version 1.5. Gary, NC: Pharsight; 1998.
18. Tracewell WG, Trump DL, Vaughan WP, et al. Population pharmacokinetics of hydroxyurea in cancer patients. Cancer Chemother Pharmacol. 1995;35:417-422.
19. Belt RJ, Hass CD, Kennedy J, Taylor S. Studies of hydroxyurea administered by continuous infusion. Cancer. 1980;46:455.
20. Veale D, Cantwell BMJ, Kerr N, et al. Phase I study of hydroxyurea in lung cancer. Cancer Chemother Pharmacol. 1988;21:53.
21. Beckloff GL, Lerner HJ, Frost D, et al. Hydroxyurea (NSC-32065) in biologic fluids: dose-concentration relationship. Cancer Chemother Rep. 1965;48:57-58.
22. Gwilt PR, Tracewell WG. Pharmacokinetics and pharmacodynamics of hydroxyurea. Clin Pharmacokinet. 1998;34:347-358.
23. Villani P, Maserati R, Regazzi MB, et al. Pharmacokinetics of hydroxyurea in patients infected with human immunodeficiency virus type 1. J Clin Pharmacol. 1996;36:117-121.
24. Newman EM, Carroll M, Akman SA, et al. Pharmacokinetics and toxicity of 120-hour continuous-infusion hydroxyurea in patients with advanced solid tumors. Cancer Chemother Pharmacol. 1997;39: 254-258.
25. Garcia AA, Muggia FM, Spears CP, et al. Phase I and pharmacologic study of i.v. hydroxyurea infusion given with i.p. 5-fluoro-2′-deoxyuridine and leucovorin. Anticancer Drugs. 2001;12:505-511.
26. Dover GJ, Humphries RK, Moore JG, et al. Hydroxyurea induction of hemoglobin F production in sickle cell disease: relationship between cytotoxicity and F cell production. Blood. 1986;67:735-738.