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

Author

Galactéros Frédéric, Pham Kim PD, Bachir Dora, Habibi Anoosha, Sassi Hind, Paule Ines, Girard Pascal, Hulin Anne, and Tod Michel

Subjects
Medicine
Abstract

Abstract Background Hydroxyurea (HU) is the first approved pharmacological treatment of sickle cell anemia (SCA). The objectives of this study were to develop population pharmacokinetic(PK)-pharmacodynamic(PD) models for HU in order to characterize the exposure-efficacy relationships and their variability, compare two dosing regimens by simulations and develop some recommendations for monitoring the treatment. Methods The models were built using population modelling software NONMEM VII based on data from two clinical studies of SCA adult patients receiving 500-2000 mg of HU once daily. Fetal hemoglobin percentage (HbF%) and mean corpuscular volume (MCV) were used as biomarkers for response. A sequential modelling approach was applied. Models were evaluated using simulation-based techniques. Comparisons of two dosing regimens were performed by simulating 10000 patients in each arm during 12 months. Results The PK profiles were described by a bicompartmental model. The median (and interindividual coefficient of variation (CV)) of clearance was 11.6 L/h (30%), the central volume was 45.3 L (35%). PK steady-state was reached in about 35 days. For a given dosing regimen, HU exposure varied approximately fivefold among patients. The dynamics of HbF% and MCV were described by turnover models with inhibition of elimination of response. In the studied range of drug exposures, the effect of HU on HbF% was at its maximum (median Imax was 0.57, CV was 27%); the effect on MCV was close to its maximum, with median value of 0.14 and CV of 49%. Simulations showed that 95% of the steady-state levels of HbF% and MCV need 26 months and 3 months to be reached, respectively. The CV of the steady-state value of HbF% was about 7 times larger than that of MCV. Simulations with two different dosing regimens showed that continuous dosing led to a stronger HbF% increase in some patients. Conclusions The high variability of response to HU was related in part to pharmacokinetics and to pharmacodynamics. The steady-state value of MCV at month 3 is not predictive of the HbF% value at month 26. Hence, HbF% level may be a better biomarker for monitoring HU treatment. Continuous dosing might be more advantageous in terms of HbF% for patients who have a strong response to HU. Trial Registration The clinical studies whose data are analysed and reported in this work were not required to be registered in France at their time. Both studies were approved by local ethics committees (of Mondor Hospital and of Kremlin-Bicetre Hospital) and written informed consent was obtained from each patient.

Published
2011
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37. Iron overload in thalassaemias and genetic haemochromatosis

Author

Aguilar-Martinez, P., Schved, J. F., Badens, C., Thuret, I., Michel, G., Neonato, M. G., Peltier, J. Y., Girot, R., Pissard, S., Galacteros, F., Bachir, D., Rose, C., Picot, M. C., Denamur, E., and Elion, J.

Published
2000

39. PF788 DATA FROM THE FRENCH REGISTRY FOR BETA-THALASSEMIA PATIENTS

Author

Agouti, I., primary, Thuret, I., additional, Bernit, E., additional, Galacteros, F., additional, Steschenko, D., additional, Brousse, V., additional, Rose, C., additional, HOT, A., additional, Ribeil, J.-A., additional, Pegourie, B., additional, Lambilliotte, A., additional, Lionnet, F., additional, Auguste, Y., additional, Loundou, A., additional, and Badens, C., additional

Published
2019
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45. PHYSIOPATHOLOGY OF HEREDITARY XEROCYTOSIS: PIEZO1 GAIN OF FUNCTION MUTATIONS IMPACT HEMOGLOBIN OXYGEN AFFINITY

Author

Kiger, L., Guitton, C., Ghazal, K., Feneant-Thibault, M., Bendelac, L., Galacteros, F., Proulle, V., Garcon, Loic, Picard, V., DESSAIVRE, Louise, Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Université Paris-Est Créteil Val-de-Marne - Faculté de médecine (UPEC Médecine), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Université de Picardie Jules Verne (UPJV), CHU Amiens-Picardie, and AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)

Subjects
[SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio], parasitic diseases, education, social sciences, health care economics and organizations, geographic locations
Abstract

22nd Congress of the European-Hematology-Association, Madrid, SPAIN, JUN 22-25, 2017; International audience

Published
2017

47. Deformities of the hip in adults who have sickle-cell disease and had avascular necrosis in childhood: a natural history of 52 patients

Author

Hernigou, P., Galacteros, F., Bachir, D., and Goutallier, D.

Subjects
Sickle cell anemia -- Complications, Hip joint -- Abnormalities, Avascular necrosis -- Complications, Health
Abstract

In children, sickle cell disease (a chronic, incurable, inherited anemia) is known to be associated with avascular necrosis (tissue death due to inadequate blood supply) of the head of the femur, or thigh bone. A most serious problem at maturity is deformity of the femoral head and late osteoarthrosis (degeneration of the bone and joint). A study was undertaken to determine the incidence of hip problems in sickle-cell patients who had avascular necrosis before the age of 15 and to evaluate the clinical and radiologic results in the mature patient. Of 160 adult patients followed for sickle cell disease, 52 patients showed X-ray evidence of having had avascular necrosis in childhood. The average age of the patients was 31 years and the average age at onset of hip disease was 12 years; thus average time to follow-up was 19 years. At most recent follow-up, 80 percent of the hips were currently painful and had permanent damage with decreased mobility, leg-length discrepancy, and abnormal gait. Sixteen percent of the hips had required surgery, and 63 percent had major problems because of pain. In the 21 hips that were without pain, five patients had abnormal gait. There were correlations found between hip score (a method of quantifying function) and the patient's age at the time of disease onset, as well as between hip score and degenerative changes in the hip. Degenerative hip changes correlated with findings of degeneration on X-rays. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1991

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