Population pharmacokinetics and pharmacodynamics of hydroxyurea in sickle cell anemia patients, a basis for optimizing the dosing regimen

Orphanet Journal of Rare Diseases

Volumn 6, Issue 1, 2011, Pages

  Paule, Ines ^a,b   Sassi, Hind ^c   Habibi, Anoosha ^c   Pham, Kim P D ^c   Bachir, Dora ^c   Galactéros, Frédéric ^c   Girard, Pascal ^a,b   Hulin, Anne ^c   Tod, Michel ^a,b,d  

^a UNIVERSITÉ DE LYON   (France)

^b UNIVERSITÉ LYON 1   (France)

^c ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^d CROIX ROUSSE HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; BIOLOGICAL MARKER; CREATININE; FERRITIN; HEMOGLOBIN; HEMOGLOBIN F; HYDROXYUREA; LACTATE DEHYDROGENASE; UREA;

ADULT; ARTICLE; BLOOD SAMPLING; BLOOD TOXICITY; BODY WEIGHT; CLINICAL ARTICLE; CLINICAL ASSESSMENT; COMPUTER PROGRAM; CONCENTRATION (PARAMETERS); DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG CLEARANCE; DRUG DOSE REGIMEN; DRUG ELIMINATION; DRUG EXPOSURE; DRUG MECHANISM; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; KIDNEY FAILURE; MALE; MEAN CORPUSCULAR HEMOGLOBIN; MEAN CORPUSCULAR VOLUME; NEUTROPHIL; PHARMACODYNAMICS; POPULATION MODEL; PROSPECTIVE STUDY; RISK BENEFIT ANALYSIS; SICKLE CELL ANEMIA; SIMULATION; STEADY STATE; THROMBOCYTE; TREATMENT DURATION; TREATMENT RESPONSE; ADOLESCENT; BIOLOGICAL MODEL; BLOOD; CLINICAL TRIAL; COMPUTER SIMULATION; DRUG ADMINISTRATION; MIDDLE AGED;

ADOLESCENT; ADULT; ANEMIA, SICKLE CELL; COMPUTER SIMULATION; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; HYDROXYUREA; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; YOUNG ADULT;

EID: 79957454428     PISSN: None     EISSN: 17501172     Source Type: Journal    
DOI: 10.1186/1750-1172-6-30     Document Type: Article

References (26)

1. Hematologic responses of patients with sickle cell disease to treatment with hydroxyurea. GP Rodgers GJ Dover CT Noguchi AN Schechter AW Nienhuis, N Engl J Med 1990 322 15 1037 1045 10.1056/NEJM199004123221504 1690857 (Pubitemid 20146662)
2. Hydroxyurea induces fetal hemoglobin by the nitric oxide-dependant activation of soluble fetal hemoglobin by the nitric oxide-dependant activation of soluble guanylyl cyclase. VP Cokic RD Smith BB Beleskin-Cokic JM Njoroge JL Miller MT Gladwin AN Schechter, J Clin Invest 2003 111 2 231 239 12531879 (Pubitemid 36105922)
3. New therapies for sickle cell disease. IE Okpala, Hematol Oncol Clin North Am 2005 19 5 975 987 10.1016/j.hoc.2005.08.004 16214656 (Pubitemid 41427122)
4. Decreased sickle red blood cell adhesion to laminin by hudroxyurea is associated with inhibition of Lu/BCAM protein phosphorylation. P Bartolucci V Chaar J Picot D Bachir A Habibi C Fauroux F Galactéros Y Colin C Le Van Kim W El Nemer, Blood 2010 116 12 2152 2159 10.1182/blood-2009-12-257444 20566895
5. Effect of hydroxyurea on the frequency of painful crises in sickle cell anemia. S Charache ML Terrin RD Moore GJ Dover FB Barton SV Eckert RP McMahon DR Bonds the investigators of the multicenter study of hydroxyurea in sickle cell anemia, N Engl J Med 1995 332 1317 1322 10.1056/NEJM199505183322001 7715639
6. Effect of hydroxyurea on mortality and morbidity in adult sickle cell anemia. MH Steinberg F Barton O Castro CH Pegelow SK Ballas A Kutlar E Orringer R Bellevue N Olivieri J Eckman M Varma G Ramirez B Adler W Smith T Carlos K Ataga L DeCastro C Bigelow Y Saunthararajah M Telfer E Vichinsky S Claster S Shurin K Bridges M Waclawiw D Bonds M Terrin, JAMA 2003 289 1645 1651 10.1001/jama.289.13.1645 12672732
7. Hydroxyurea for the treatment of sickle cell anemia. OS Platt, N Engl J Med 2008 358 13 1362 1369 10.1056/NEJMct0708272 18367739
8. A vision for the future of genomics research. FS Collins ED Green AE Guttmacher MS Guyer, Nature 2003 422 6934 835 847 10.1038/nature01626 12695777 (Pubitemid 36520032)
9. Fetal hemoglobin in sickle cell anemia: genetic determinants of response to hydroxyurea. Q Ma DF Wyszynski JJ Farrell A Kutlar LA Farrer CT Baldwin MH Steinberg, Pharmacogenomics J 2007 7 386 394 10.1038/sj.tpj.6500433 17299377 (Pubitemid 350187450)
10. Fetal haemoglobin response to hydroxycarbamide treatment and sar1a promoter polymorphisms in sickle cell anaemia. C Kumkhaek C Kumkhaek JG Taylor J Zhu C Hoppe GJ Kato GP Rodgers, Br J Haematol 2008 141 254 259 10.1111/j.1365-2141.2008.07045.x 18318767 (Pubitemid 351406217)
11. Plasma and urine hydroxyurea levels might be useful in the management of adult sickle cell disease. D Bachir A Hulin E Huet A Habibi R Nzouakou M El Mahrab A Astier F Galacteros, Hemoglobin 2007 31 4 417 425 10.1080/ 03630260701587745 17994375 (Pubitemid 350125631)
12. Pharmacokinetics of hydroxyurea 1000 mg coated breakable tablets and 500 mg capsules in pediatric and adult patients with sickle cell disease. M De Montalembert D Bachir A Hulin L Gimeno A Mogenet JL Bresson I Macquin-Mavier F Roudot-Thoraval A Astier F Galactéros, Haematologica 2006 91 12 1685 1688 17145606 (Pubitemid 46032966)
13. S Beal LB Sheiner A Boeckmann RJ Bauer, NONMEM User's Guides (1989-2009) Ellicott City, Icon Development Solutions 2009 21575245
14. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. K Brendel E Comets C Laffont C Laveille F Mentré Pharm Res 2006 23 2036 2049 10.1007/s11095-006-9067-5 16906454
15. Ways to fit a PK model with some data below the quantification limit. SL Beal, J Pharmacokinet Pharmacodyn 2001 28 5 481 504 10.1023/A:1012299115260 11768292 (Pubitemid 33151426)
16. Prediction of creatinine clearance from serum creatinine. D Cockcroft MD Gault, Nephron 1976 16 1 31 41 10.1159/000180580 1244564
17. Mathematical formalism and characteristics of four basic models of indirect pharmacodynamic responses for drug infusions. W Krzyzanski WJ Jusko, J Pharmacokinet Biopharm 1998 26 4 385 408 10.1023/A:1021060000789 10214559 (Pubitemid 29153519)
18. Evaluating the IPPSE method for PKPD analysis [abstract]. BD Lacroix LE Friberg MO Karlsson, Population Approach Group in Europe: 8-11 June 2010; Berlin http://www.page-meeting.org/default.asp?abstract=1843 Abstract Nr. 1843
19. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. M Bergstrand AC Hooker JE Wallin MO Karlsson, AAPS J Published online 08-02-2011.
20. Pharmacokinetics and pharmacodynamics of hydroxyurea. PR Gwilt WG Tracewell, Clin Pharmacokinet 1998 34 5 347 358 10.2165/00003088-199834050-00002 9592619 (Pubitemid 28192905)
21. A general model for the origin of allometric scaling laws in biology. GB West JH Brown BJ Enquist, Science 1997 276 5309 122 6 10.1126/science.276.5309. 122 9082983 (Pubitemid 27161259)
22. What is the best size descriptor to use for pharmacokinetic studies in the obese? B Green SB Duffull, Br J Clin Pharmacol 2004 58 2 119 33 10.1111/j.1365-2125.2004.02157.x 15255794 (Pubitemid 39043992)
23. Systematic review: Hydroxyurea for the treatment of adults with sickle cell disease. S Lanzkron JJ Strouse R Wilson MC Beach C Haywood H Park C Witkop EB Bass JB Segal, Ann Intern Med 2008 148 12 939 955 18458272 (Pubitemid 351860826)
24. The hydroxyurea-induced small GTP-binding protein SAR modulates gamma-globin gene expression in human erythroid cells. DC Tang J Zhu W Liu K Chin J Sun L Chen JA Hanover GP Rodgers, Blood 2005 106 3256 3263 10.1182/blood-2003-10-3458 15985540 (Pubitemid 41565927)
25. Physiopathology of sickle cell disease is mirrored by red blood cells metabolome. D Darghouth B Koehl G Madalinski JF Heilier P Bovee Y Xu MF Olivier P Bartolucci M Benkerrou S Pissard Y Colin F Galacteros G Bosman C Junot PH Roméo, Blood 2010 prepublished online December 6
26. Phosphatidylserine externalization in sickle red blood cells: associations with cell age, density, and hemoglobin F. Z Yasin S Witting MB Palascak CH Joiner DL Rucknagel RS Franco, Blood 2003 102 1 365 370 10.1182/blood-2002-11-3416 12609840 (Pubitemid 36759678)