Population Pharmacokinetics of Oral Baclofen in Pediatric Patients with Cerebral Palsy
To characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in order to support its clinical use. Children (2-17 years of age) with CP received a dose of titrated oral baclofen from 2.5 mg 3 times a day t...
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| Published in | The Journal of pediatrics Vol. 164; no. 5; pp. 1181 - 1188.e8 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.05.2014
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0022-3476 1097-6833 1097-6833 |
| DOI | 10.1016/j.jpeds.2014.01.029 |
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| Abstract | To characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in order to support its clinical use.
Children (2-17 years of age) with CP received a dose of titrated oral baclofen from 2.5 mg 3 times a day to a maximum tolerated dose of up to 20 mg 4 times a day. PK sampling followed titration of 10-12 weeks. Serial R- and S-baclofen plasma concentrations were measured for up to 16 hours in 49 subjects. Population PK modeling was performed using NONMEM 7.1 (ICON PLC; Ellicott City, Maryland).
R- and S-baclofen showed identical concentration-time profiles. Both baclofen enantiomers exhibited linear and dose/kg-proportional PK, and no sex differences were observed. Average baclofen terminal half-life was 4.5 hours. A 2-compartment PK model with linear elimination and transit absorption steps adequately described concentration-time profiles of both baclofen enantiomers. The mean population estimate of apparent clearance/F was 0.273 L/h/kg with 33.4% inter-individual variability (IIV), and the apparent volume of distribution (Vss/F) was 1.16 L/kg with 43.9% IIV. Delayed absorption was expressed by a mean transit time of 0.389 hours with 83.7% IIV. Body weight, a possible genetic factor, and age were determinants of apparent clearance in these children.
The PK of oral baclofen exhibited dose-proportionality and were adequately described by a 2-compartment model. Our population PK findings suggest that baclofen dosage can be based on body weight (2 mg/kg per day) and the current baclofen dose escalation strategy is appropriate in the treatment of children with CP older than 2 years of age. |
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| AbstractList | To characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in order to support its clinical use.OBJECTIVETo characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in order to support its clinical use.Children (2-17 years of age) with CP received a dose of titrated oral baclofen from 2.5 mg 3 times a day to a maximum tolerated dose of up to 20 mg 4 times a day. PK sampling followed titration of 10-12 weeks. Serial R- and S-baclofen plasma concentrations were measured for up to 16 hours in 49 subjects. Population PK modeling was performed using NONMEM 7.1 (ICON PLC; Ellicott City, Maryland).SUBJECTS DESIGNChildren (2-17 years of age) with CP received a dose of titrated oral baclofen from 2.5 mg 3 times a day to a maximum tolerated dose of up to 20 mg 4 times a day. PK sampling followed titration of 10-12 weeks. Serial R- and S-baclofen plasma concentrations were measured for up to 16 hours in 49 subjects. Population PK modeling was performed using NONMEM 7.1 (ICON PLC; Ellicott City, Maryland).R- and S-baclofen showed identical concentration-time profiles. Both baclofen enantiomers exhibited linear and dose/kg-proportional PK, and no sex differences were observed. Average baclofen terminal half-life was 4.5 hours. A 2-compartment PK model with linear elimination and transit absorption steps adequately described concentration-time profiles of both baclofen enantiomers. The mean population estimate of apparent clearance/F was 0.273 L/h/kg with 33.4% inter-individual variability (IIV), and the apparent volume of distribution (Vss/F) was 1.16 L/kg with 43.9% IIV. Delayed absorption was expressed by a mean transit time of 0.389 hours with 83.7% IIV. Body weight, a possible genetic factor, and age were determinants of apparent clearance in these children.RESULTSR- and S-baclofen showed identical concentration-time profiles. Both baclofen enantiomers exhibited linear and dose/kg-proportional PK, and no sex differences were observed. Average baclofen terminal half-life was 4.5 hours. A 2-compartment PK model with linear elimination and transit absorption steps adequately described concentration-time profiles of both baclofen enantiomers. The mean population estimate of apparent clearance/F was 0.273 L/h/kg with 33.4% inter-individual variability (IIV), and the apparent volume of distribution (Vss/F) was 1.16 L/kg with 43.9% IIV. Delayed absorption was expressed by a mean transit time of 0.389 hours with 83.7% IIV. Body weight, a possible genetic factor, and age were determinants of apparent clearance in these children.The PK of oral baclofen exhibited dose-proportionality and were adequately described by a 2-compartment model. Our population PK findings suggest that baclofen dosage can be based on body weight (2 mg/kg per day) and the current baclofen dose escalation strategy is appropriate in the treatment of children with CP older than 2 years of age.CONCLUSIONThe PK of oral baclofen exhibited dose-proportionality and were adequately described by a 2-compartment model. Our population PK findings suggest that baclofen dosage can be based on body weight (2 mg/kg per day) and the current baclofen dose escalation strategy is appropriate in the treatment of children with CP older than 2 years of age. To characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in order to support its clinical use. Children (2-17 years of age) with CP received a dose of titrated oral baclofen from 2.5 mg 3 times a day to a maximum tolerated dose of up to 20 mg 4 times a day. PK sampling followed titration of 10-12 weeks. Serial R- and S-baclofen plasma concentrations were measured for up to 16 hours in 49 subjects. Population PK modeling was performed using NONMEM 7.1 (ICON PLC; Ellicott City, Maryland). R- and S-baclofen showed identical concentration-time profiles. Both baclofen enantiomers exhibited linear and dose/kg-proportional PK, and no sex differences were observed. Average baclofen terminal half-life was 4.5 hours. A 2-compartment PK model with linear elimination and transit absorption steps adequately described concentration-time profiles of both baclofen enantiomers. The mean population estimate of apparent clearance/F was 0.273 L/h/kg with 33.4% inter-individual variability (IIV), and the apparent volume of distribution (Vss/F) was 1.16 L/kg with 43.9% IIV. Delayed absorption was expressed by a mean transit time of 0.389 hours with 83.7% IIV. Body weight, a possible genetic factor, and age were determinants of apparent clearance in these children. The PK of oral baclofen exhibited dose-proportionality and were adequately described by a 2-compartment model. Our population PK findings suggest that baclofen dosage can be based on body weight (2 mg/kg per day) and the current baclofen dose escalation strategy is appropriate in the treatment of children with CP older than 2 years of age. To characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in order to support its clinical use. Children (2-17 years of age) with CP received a dose of titrated oral baclofen from 2.5 mg 3 times a day to a maximum tolerated dose of up to 20 mg 4 times a day. PK sampling followed titration of 10-12 weeks. Serial R- and S-baclofen plasma concentrations were measured for up to 16 hours in 49 subjects. Population PK modeling was performed using NONMEM 7.1 (ICON PLC; Ellicott City, Maryland). R- and S-baclofen showed identical concentration-time profiles. Both baclofen enantiomers exhibited linear and dose/kg-proportional PK, and no sex differences were observed. Average baclofen terminal half-life was 4.5 hours. A 2-compartment PK model with linear elimination and transit absorption steps adequately described concentration-time profiles of both baclofen enantiomers. The mean population estimate of apparent clearance/F was 0.273 L/h/kg with 33.4% inter-individual variability (IIV), and the apparent volume of distribution (Vss/F) was 1.16 L/kg with 43.9% IIV. Delayed absorption was expressed by a mean transit time of 0.389 hours with 83.7% IIV. Body weight, a possible genetic factor, and age were determinants of apparent clearance in these children. The PK of oral baclofen exhibited dose-proportionality and were adequately described by a 2-compartment model. Our population PK findings suggest that baclofen dosage can be based on body weight (2 mg/kg per day) and the current baclofen dose escalation strategy is appropriate in the treatment of children with CP older than 2 years of age. Objective To characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in order to support its clinical use. Subjects design Children (2-17 years of age) with CP received a dose of titrated oral baclofen from 2.5 mg 3 times a day to a maximum tolerated dose of up to 20 mg 4 times a day. PK sampling followed titration of 10-12 weeks. Serial R- and S-baclofen plasma concentrations were measured for up to 16 hours in 49 subjects. Population PK modeling was performed using NONMEM 7.1 (ICON PLC; Ellicott City, Maryland). Results R- and S-baclofen showed identical concentration-time profiles. Both baclofen enantiomers exhibited linear and dose/kg-proportional PK, and no sex differences were observed. Average baclofen terminal half-life was 4.5 hours. A 2-compartment PK model with linear elimination and transit absorption steps adequately described concentration-time profiles of both baclofen enantiomers. The mean population estimate of apparent clearance/F was 0.273 L/h/kg with 33.4% inter-individual variability (IIV), and the apparent volume of distribution (Vss /F) was 1.16 L/kg with 43.9% IIV. Delayed absorption was expressed by a mean transit time of 0.389 hours with 83.7% IIV. Body weight, a possible genetic factor, and age were determinants of apparent clearance in these children. Conclusion The PK of oral baclofen exhibited dose-proportionality and were adequately described by a 2-compartment model. Our population PK findings suggest that baclofen dosage can be based on body weight (2 mg/kg per day) and the current baclofen dose escalation strategy is appropriate in the treatment of children with CP older than 2 years of age. |
| Author | Roge, Desiree Tilton, Ann Kuroda, Maxine M. Dai, Hongying Jusko, William J. Butler, Maureen Brunstrom-Hernandez, Janice E. Kennedy, Diane Gaebler-Spira, Deborah He, Yang Lewandowski, Andrew Christensen, Ana Thio, Liu Lin Schwabe, Aloysia Krach, Linda E. Vargus-Adams, Jilda Leeder, J. Steven Gaedigk, Andrea Stevenson, Richard D. Lackey, Shellie Lowenhaupt, Stephanie McLaughlin, John F. Lopez, Christina Hoon, Alexander H. Stashinko, Elaine Dosa, Nienke P. |
| AuthorAffiliation | 11 Center for Development, Behavior, and Genetics 12 Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY 8 Department of Pediatrics-Developmental Pediatrics 2 Pediatric Neurology Cerebral Palsy Center and Departments of Neurology and Pediatrics, Washington University School of Medicine and St. Louis Children's Hospital 4 Rehabilitation Institute of Chicago 16 Department of Neurology and Pediatrics, Louisiana State University Health Sciences Center, New Orleans, LA 18 The EMMES Corporation, Rockville, MD 15 Department of Rehabilitation Medicine, Children's Mercy Hospital, Kansas City, MO 19 Department of Medical Research 9 Department of Neurology, University of Virginia School of Medicine, Charlottesville, VA 1 Department of Pharmaceutical Sciences, University at Buffalo SUNY, Buffalo, NY 6 Department of Neurology and Developmental Medicine, Kennedy Krieger Institute and Johns Hopkins University, Baltimore, MD 3 Department of Urology, St. Louis Children's Hospital, St. Louis, MO |
| AuthorAffiliation_xml | – name: 7 Division of Pediatric Rehabilitation, Cincinnati Children's Hospital Medical Center, and Center for Epidemiology and Biostatistics, University of Cincinnati College of Medicine, Cincinnati, OH – name: 19 Department of Medical Research – name: 8 Department of Pediatrics-Developmental Pediatrics – name: 1 Department of Pharmaceutical Sciences, University at Buffalo SUNY, Buffalo, NY – name: 14 Department of Pediatric Neurology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX – name: 20 Division of Clinical Pharmacology and Therapeutic Innovation, Department of Pediatrics, Children's Mercy Hospitals and Clinics, Kansas City, MO – name: 3 Department of Urology, St. Louis Children's Hospital, St. Louis, MO – name: 13 Department of Physical Medicine and Rehabilitation – name: 12 Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY – name: 18 The EMMES Corporation, Rockville, MD – name: 15 Department of Rehabilitation Medicine, Children's Mercy Hospital, Kansas City, MO – name: 6 Department of Neurology and Developmental Medicine, Kennedy Krieger Institute and Johns Hopkins University, Baltimore, MD – name: 9 Department of Neurology, University of Virginia School of Medicine, Charlottesville, VA – name: 17 Department of Physical Medicine and Rehabilitation, University of Minnesota, Minneapolis, MN – name: 4 Rehabilitation Institute of Chicago – name: 10 Department of Pediatrics Developmental Medicine, Seattle Children's Hospital, Seattle, WA – name: 11 Center for Development, Behavior, and Genetics – name: 2 Pediatric Neurology Cerebral Palsy Center and Departments of Neurology and Pediatrics, Washington University School of Medicine and St. Louis Children's Hospital – name: 16 Department of Neurology and Pediatrics, Louisiana State University Health Sciences Center, New Orleans, LA – name: 5 Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine at Northwestern University, Chicago, IL |
| Author_xml | – sequence: 1 givenname: Yang surname: He fullname: He, Yang organization: Department of Pharmaceutical Sciences, University at Buffalo SUNY, Buffalo, NY – sequence: 2 givenname: Janice E. surname: Brunstrom-Hernandez fullname: Brunstrom-Hernandez, Janice E. organization: Pediatric Neurology Cerebral Palsy Center and Departments of Neurology and Pediatrics, Washington University School of Medicine and St. Louis Children's Hospital, St. Louis, MO – sequence: 3 givenname: Liu Lin surname: Thio fullname: Thio, Liu Lin organization: Pediatric Neurology Cerebral Palsy Center and Departments of Neurology and Pediatrics, Washington University School of Medicine and St. Louis Children's Hospital, St. Louis, MO – sequence: 4 givenname: Shellie surname: Lackey fullname: Lackey, Shellie organization: Department of Urology, St. Louis Children's Hospital, St. Louis, MO – sequence: 5 givenname: Deborah surname: Gaebler-Spira fullname: Gaebler-Spira, Deborah organization: Rehabilitation Institute of Chicago, Feinberg School of Medicine at Northwestern University, Chicago, IL – sequence: 6 givenname: Maxine M. surname: Kuroda fullname: Kuroda, Maxine M. organization: Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine at Northwestern University, Chicago, IL – sequence: 7 givenname: Elaine surname: Stashinko fullname: Stashinko, Elaine organization: Department of Neurology and Developmental Medicine, Kennedy Krieger Institute and Johns Hopkins University, Baltimore, MD – sequence: 8 givenname: Alexander H. surname: Hoon fullname: Hoon, Alexander H. organization: Department of Neurology and Developmental Medicine, Kennedy Krieger Institute and Johns Hopkins University, Baltimore, MD – sequence: 9 givenname: Jilda surname: Vargus-Adams fullname: Vargus-Adams, Jilda organization: Division of Pediatric Rehabilitation, Cincinnati Children's Hospital Medical Center, and Center for Epidemiology and Biostatistics, University of Cincinnati College of Medicine, Cincinnati, OH – sequence: 10 givenname: Richard D. surname: Stevenson fullname: Stevenson, Richard D. organization: Department of Pediatrics-Developmental Pediatrics, University of Virginia School of Medicine, Charlottesville, VA – sequence: 11 givenname: Stephanie surname: Lowenhaupt fullname: Lowenhaupt, Stephanie organization: Department of Neurology, University of Virginia School of Medicine, Charlottesville, VA – sequence: 12 givenname: John F. surname: McLaughlin fullname: McLaughlin, John F. organization: Department of Pediatrics Developmental Medicine, Seattle Children's Hospital, Seattle, WA – sequence: 13 givenname: Ana surname: Christensen fullname: Christensen, Ana organization: Department of Pediatrics Developmental Medicine, Seattle Children's Hospital, Seattle, WA – sequence: 14 givenname: Nienke P. surname: Dosa fullname: Dosa, Nienke P. organization: Center for Development, Behavior, and Genetics, SUNY Upstate Medical University, Syracuse, NY – sequence: 15 givenname: Maureen surname: Butler fullname: Butler, Maureen organization: Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY – sequence: 16 givenname: Aloysia surname: Schwabe fullname: Schwabe, Aloysia organization: Department of Physical Medicine and Rehabilitation, Baylor College of Medicine and Texas Children's Hospital, Houston, TX – sequence: 17 givenname: Christina surname: Lopez fullname: Lopez, Christina organization: Department of Pediatric Neurology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX – sequence: 18 givenname: Desiree surname: Roge fullname: Roge, Desiree organization: Department of Rehabilitation Medicine, Children's Mercy Hospital, Kansas City, MO – sequence: 19 givenname: Diane surname: Kennedy fullname: Kennedy, Diane organization: Department of Rehabilitation Medicine, Children's Mercy Hospital, Kansas City, MO – sequence: 20 givenname: Ann surname: Tilton fullname: Tilton, Ann organization: Department of Neurology and Pediatrics, Louisiana State University Health Sciences Center, New Orleans, LA – sequence: 21 givenname: Linda E. surname: Krach fullname: Krach, Linda E. organization: Department of Physical Medicine and Rehabilitation, University of Minnesota, Minneapolis, MN – sequence: 22 givenname: Andrew surname: Lewandowski fullname: Lewandowski, Andrew organization: The EMMES Corporation, Rockville, MD – sequence: 23 givenname: Hongying surname: Dai fullname: Dai, Hongying organization: Department of Medical Research, Children's Mercy Hospitals and Clinics, Kansas City, MO – sequence: 24 givenname: Andrea surname: Gaedigk fullname: Gaedigk, Andrea organization: Division of Clinical Pharmacology and Therapeutic Innovation, Department of Pediatrics, Children's Mercy Hospitals and Clinics, Kansas City, MO – sequence: 25 givenname: J. 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| Snippet | To characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in... Objective To characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral... |
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| SubjectTerms | Absorption Administration, Oral Adolescent Baclofen - blood Baclofen - pharmacokinetics Baclofen - therapeutic use Body Weight Cerebral Palsy - blood Cerebral Palsy - drug therapy Child Child, Preschool Dose-Response Relationship, Drug Drug Administration Schedule Female Half-Life Humans Male Metabolic Clearance Rate Models, Statistical Multivariate Analysis Muscle Relaxants, Central - blood Muscle Relaxants, Central - pharmacokinetics Muscle Relaxants, Central - therapeutic use Pediatrics |
| Title | Population Pharmacokinetics of Oral Baclofen in Pediatric Patients with Cerebral Palsy |
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