About: The pharmacology of multiple regimens of agalsidase alfa enzyme replacement therapy for Fabry disease

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Description	Autoři popisují farmakologii podávání alfa-galaktosidázy alfa v různých léčebných režimech v rámci enzym-substituční léčby Fabryho chorob (cs) Purpose: This 10-week study was conducted to determine the pharmacokinetics of varying doses of agalsidase alfa and evaluate the effect of dose and dosing frequency on plasma Gb(3) levels. Methods: Eighteen adult male Fabry patients, naive to enzyme replacement therapy, were randomized to one of five regimens: 0.1, 0.2, or 0.4 mg/kg weekly; 0.2 mg/kg every other week (the approved dose); or 0.4 mg/kg every other week. Intravenous infusion rate was 0.1 mg/kg per 20 minutes. Plasma Gb(3) levels were assessed at baseline and periodically during the study. Results: The mean half-life was 56-76 minutes, and the mean volume of distribution at steady state was 17%-18% of body weight, with no significant association between dose and half-life, clearance, or volume of distribution at steady state. The area under the curve was linearly proportional to the dose from 0.1 to 0.4 mg/kg. Baseline average plasma Gb(3) was 9.12 +/- 2.61 nmol/mL and after 10 weeks of treatment was significantly reduced by about 50% in Purpose: This 10-week study was conducted to determine the pharmacokinetics of varying doses of agalsidase alfa and evaluate the effect of dose and dosing frequency on plasma Gb(3) levels. Methods: Eighteen adult male Fabry patients, naive to enzyme replacement therapy, were randomized to one of five regimens: 0.1, 0.2, or 0.4 mg/kg weekly; 0.2 mg/kg every other week (the approved dose); or 0.4 mg/kg every other week. Intravenous infusion rate was 0.1 mg/kg per 20 minutes. Plasma Gb(3) levels were assessed at baseline and periodically during the study. Results: The mean half-life was 56-76 minutes, and the mean volume of distribution at steady state was 17%-18% of body weight, with no significant association between dose and half-life, clearance, or volume of distribution at steady state. The area under the curve was linearly proportional to the dose from 0.1 to 0.4 mg/kg. Baseline average plasma Gb(3) was 9.12 +/- 2.61 nmol/mL and after 10 weeks of treatment was significantly reduced by about 50% in (en)
Title	The pharmacology of multiple regimens of agalsidase alfa enzyme replacement therapy for Fabry disease The pharmacology of multiple regimens of agalsidase alfa enzyme replacement therapy for Fabry disease (en) Farmakologie podávání alfa-galaktosidázy alfa v různých léčebných režimech v rámci enzym-substituční léčby Fabryho chorob (cs)
skos:prefLabel	The pharmacology of multiple regimens of agalsidase alfa enzyme replacement therapy for Fabry disease The pharmacology of multiple regimens of agalsidase alfa enzyme replacement therapy for Fabry disease (en) Farmakologie podávání alfa-galaktosidázy alfa v různých léčebných režimech v rámci enzym-substituční léčby Fabryho chorob (cs)
skos:notation	RIV/00216208:11120/07:00000484!RIV08-MSM-11120___
http://linked.open.../vavai/riv/strany	504-509
http://linked.open...avai/riv/aktivita	V
http://linked.open...avai/riv/aktivity	V
http://linked.open...iv/cisloPeriodika	8
http://linked.open...vai/riv/dodaniDat	2008
http://linked.open...aciTvurceVysledku	Bultas, Jan
http://linked.open.../riv/druhVysledku	J - Článek v odborném periodiku
http://linked.open...iv/duvernostUdaju	S - Úplné a pravdivé údaje nepodléhající ochraně podle zvláštních právních předpisů
http://linked.open...titaPredkladatele	Univerzita Karlova v Praze / 3. lékařská fakulta
http://linked.open...dnocenehoVysledku	441152
http://linked.open...ai/riv/idVysledku	RIV/00216208:11120/07:00000484
http://linked.open...riv/jazykVysledku	eng - angličtina
http://linked.open.../riv/klicovaSlova	Fabry disease; agalsidase alfa; enzyme replacement therapy; pharmacodynamics; dose response (en)
http://linked.open.../riv/klicoveSlovo	pharmacodynamics enzyme replacement therapy dose response Fabry disease agalsidase alfa
http://linked.open...odStatuVydavatele	US - Spojené státy americké
http://linked.open...ontrolniKodProRIV	[E35F1C77CA23]
http://linked.open...i/riv/nazevZdroje	Genetetics in Medicine
http://linked.open...in/vavai/riv/obor	FR
http://linked.open...ichTvurcuVysledku	1 (xsd:int)
http://linked.open...cetTvurcuVysledku	4 (xsd:int)
http://linked.open...UplatneniVysledku	2007
http://linked.open...v/svazekPeriodika	9
http://linked.open...iv/tvurceVysledku	Bultas, Jan Clarke, J. T. R. Schiffmann, R. West, M. L.
issn	1098-3600
number of pages	6 (xsd:int)
http://localhost/t...ganizacniJednotka	11120

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