Model‐based lamotrigine clearance changes during pregnancy: clinical implication

Objective The objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the postpartum period through a model‐based approach incorporating clinical characteristics that may influence CL/F, in support of developing clinical m...

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Published inAnnals of clinical and translational neurology Vol. 1; no. 2; pp. 99 - 106
Main Authors Polepally, Akshanth R., Pennell, Page B., Brundage, Richard C., Stowe, Zachary N., Newport, Donald J., Viguera, Adele C., Ritchie, James C., Birnbaum, Angela K.
Format Journal Article
LanguageEnglish
Published United States John Wiley & Sons, Inc 01.02.2014
BlackWell Publishing Ltd
Subjects
Bipolar disorder
Convulsions & seizures
Diaries
Drug dosages
Epilepsy
Mental disorders
Pregnancy
Research Papers
Studies
Womens health
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Abstract Objective The objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the postpartum period through a model‐based approach incorporating clinical characteristics that may influence CL/F, in support of developing clinical management guidelines. Methods Women receiving LTG therapy who were pregnant or planning pregnancy were enrolled. Maternal blood samples were collected at each visit. A pharmacokinetic analysis was performed using a population‐based, nonlinear, mixed‐effects model. Results A total of 600 LTG concentrations from 60 women (64 pregnancies) were included. The baseline LTG CL/F was 2.16 L/h with a between‐subject variability of 40.6%. The influence of pregnancy on CL/F was described by gestational week. Two subpopulations of women emerged based on the rate of increase in LTG CL/F during pregnancy. The gestational age‐associated increase in CL/F displayed a 10‐fold higher rate in 77% of the women (0.118 L/h per week) compared to 23% (0.0115 L/h per week). The between‐subject variability in these slopes was 43.0%. The increased CL/F at delivery declined to baseline values with a half‐life of 0.55 weeks. Interpretation The majority of women had a substantial increase in CL/F from 2.16 to 6.88 L/h by the end of pregnancy, whereas 23% of women had a minimal increase. An increase in CL/F may correspond to decreases in LTG blood concentrations necessitating the need for more frequent dosage adjustments and closer monitoring in some pregnant women with epilepsy. Postpartum doses should be tapered to preconception dose ranges within 3 weeks of delivery.
AbstractList Objective The objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the postpartum period through a model‐based approach incorporating clinical characteristics that may influence CL/F, in support of developing clinical management guidelines. Methods Women receiving LTG therapy who were pregnant or planning pregnancy were enrolled. Maternal blood samples were collected at each visit. A pharmacokinetic analysis was performed using a population‐based, nonlinear, mixed‐effects model. Results A total of 600 LTG concentrations from 60 women (64 pregnancies) were included. The baseline LTG CL/F was 2.16 L/h with a between‐subject variability of 40.6%. The influence of pregnancy on CL/F was described by gestational week. Two subpopulations of women emerged based on the rate of increase in LTG CL/F during pregnancy. The gestational age‐associated increase in CL/F displayed a 10‐fold higher rate in 77% of the women (0.118 L/h per week) compared to 23% (0.0115 L/h per week). The between‐subject variability in these slopes was 43.0%. The increased CL/F at delivery declined to baseline values with a half‐life of 0.55 weeks. Interpretation The majority of women had a substantial increase in CL/F from 2.16 to 6.88 L/h by the end of pregnancy, whereas 23% of women had a minimal increase. An increase in CL/F may correspond to decreases in LTG blood concentrations necessitating the need for more frequent dosage adjustments and closer monitoring in some pregnant women with epilepsy. Postpartum doses should be tapered to preconception dose ranges within 3 weeks of delivery.
ObjectiveThe objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the postpartum period through a model‐based approach incorporating clinical characteristics that may influence CL/F, in support of developing clinical management guidelines.MethodsWomen receiving LTG therapy who were pregnant or planning pregnancy were enrolled. Maternal blood samples were collected at each visit. A pharmacokinetic analysis was performed using a population‐based, nonlinear, mixed‐effects model.ResultsA total of 600 LTG concentrations from 60 women (64 pregnancies) were included. The baseline LTG CL/F was 2.16 L/h with a between‐subject variability of 40.6%. The influence of pregnancy on CL/F was described by gestational week. Two subpopulations of women emerged based on the rate of increase in LTG CL/F during pregnancy. The gestational age‐associated increase in CL/F displayed a 10‐fold higher rate in 77% of the women (0.118 L/h per week) compared to 23% (0.0115 L/h per week). The between‐subject variability in these slopes was 43.0%. The increased CL/F at delivery declined to baseline values with a half‐life of 0.55 weeks.InterpretationThe majority of women had a substantial increase in CL/F from 2.16 to 6.88 L/h by the end of pregnancy, whereas 23% of women had a minimal increase. An increase in CL/F may correspond to decreases in LTG blood concentrations necessitating the need for more frequent dosage adjustments and closer monitoring in some pregnant women with epilepsy. Postpartum doses should be tapered to preconception dose ranges within 3 weeks of delivery.
The objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the postpartum period through a model-based approach incorporating clinical characteristics that may influence CL/F, in support of developing clinical management guidelines. Women receiving LTG therapy who were pregnant or planning pregnancy were enrolled. Maternal blood samples were collected at each visit. A pharmacokinetic analysis was performed using a population-based, nonlinear, mixed-effects model. A total of 600 LTG concentrations from 60 women (64 pregnancies) were included. The baseline LTG CL/F was 2.16 L/h with a between-subject variability of 40.6%. The influence of pregnancy on CL/F was described by gestational week. Two subpopulations of women emerged based on the rate of increase of LTG CL/F during pregnancy. The gestational age-associated increase in CL/F displayed a ten-fold higher rate in 77% of the women (0.118 L/h/week) compared to 23% (0.0115 L/h/week). The between-subject variability in these slopes was 43.0%. The increased CL/F at delivery declined to baseline values with a half-life of 0.55 weeks. The majority of women had a substantial increase in CL/F from 2.16 to 6.88 L/h by the end of pregnancy, whereas 23% of women had a minimal increase. An increase in CL/F may correspond to decreases in LTG blood concentrations necessitating the need for more frequent dosage adjustments and closer monitoring in some pregnant women with epilepsy. Postpartum doses should be tapered to preconception dose ranges within 3 weeks of delivery.
The objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the postpartum period through a model-based approach incorporating clinical characteristics that may influence CL/F, in support of developing clinical management guidelines.OBJECTIVEThe objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the postpartum period through a model-based approach incorporating clinical characteristics that may influence CL/F, in support of developing clinical management guidelines.Women receiving LTG therapy who were pregnant or planning pregnancy were enrolled. Maternal blood samples were collected at each visit. A pharmacokinetic analysis was performed using a population-based, nonlinear, mixed-effects model.METHODSWomen receiving LTG therapy who were pregnant or planning pregnancy were enrolled. Maternal blood samples were collected at each visit. A pharmacokinetic analysis was performed using a population-based, nonlinear, mixed-effects model.A total of 600 LTG concentrations from 60 women (64 pregnancies) were included. The baseline LTG CL/F was 2.16 L/h with a between-subject variability of 40.6%. The influence of pregnancy on CL/F was described by gestational week. Two subpopulations of women emerged based on the rate of increase of LTG CL/F during pregnancy. The gestational age-associated increase in CL/F displayed a ten-fold higher rate in 77% of the women (0.118 L/h/week) compared to 23% (0.0115 L/h/week). The between-subject variability in these slopes was 43.0%. The increased CL/F at delivery declined to baseline values with a half-life of 0.55 weeks.RESULTSA total of 600 LTG concentrations from 60 women (64 pregnancies) were included. The baseline LTG CL/F was 2.16 L/h with a between-subject variability of 40.6%. The influence of pregnancy on CL/F was described by gestational week. Two subpopulations of women emerged based on the rate of increase of LTG CL/F during pregnancy. The gestational age-associated increase in CL/F displayed a ten-fold higher rate in 77% of the women (0.118 L/h/week) compared to 23% (0.0115 L/h/week). The between-subject variability in these slopes was 43.0%. The increased CL/F at delivery declined to baseline values with a half-life of 0.55 weeks.The majority of women had a substantial increase in CL/F from 2.16 to 6.88 L/h by the end of pregnancy, whereas 23% of women had a minimal increase. An increase in CL/F may correspond to decreases in LTG blood concentrations necessitating the need for more frequent dosage adjustments and closer monitoring in some pregnant women with epilepsy. Postpartum doses should be tapered to preconception dose ranges within 3 weeks of delivery.INTERPRETATIONThe majority of women had a substantial increase in CL/F from 2.16 to 6.88 L/h by the end of pregnancy, whereas 23% of women had a minimal increase. An increase in CL/F may correspond to decreases in LTG blood concentrations necessitating the need for more frequent dosage adjustments and closer monitoring in some pregnant women with epilepsy. Postpartum doses should be tapered to preconception dose ranges within 3 weeks of delivery.
Author Pennell, Page B.
Stowe, Zachary N.
Viguera, Adele C.
Brundage, Richard C.
Polepally, Akshanth R.
Ritchie, James C.
Newport, Donald J.
Birnbaum, Angela K.
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  givenname: Akshanth R.
  surname: Polepally
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  organization: University of Minnesota
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  givenname: Page B.
  surname: Pennell
  fullname: Pennell, Page B.
  organization: Harvard Medical School
– sequence: 3
  givenname: Richard C.
  surname: Brundage
  fullname: Brundage, Richard C.
  organization: University of Minnesota
– sequence: 4
  givenname: Zachary N.
  surname: Stowe
  fullname: Stowe, Zachary N.
  organization: University of Arkansas for Medical Sciences
– sequence: 5
  givenname: Donald J.
  surname: Newport
  fullname: Newport, Donald J.
  organization: Emory University School of Medicine
– sequence: 6
  givenname: Adele C.
  surname: Viguera
  fullname: Viguera, Adele C.
  organization: Cleveland Clinic
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  givenname: James C.
  surname: Ritchie
  fullname: Ritchie, James C.
  organization: Emory University School of Medicine
– sequence: 8
  givenname: Angela K.
  surname: Birnbaum
  fullname: Birnbaum, Angela K.
  organization: University of Minnesota
BackLink https://www.ncbi.nlm.nih.gov/pubmed/24883336$$D View this record in MEDLINE/PubMed
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Snippet Objective The objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the...
The objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the postpartum period...
ObjectiveThe objective of the study was to characterize changes in the oral clearance (CL/F) of lamotrigine (LTG) over the course of pregnancy and the...
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SourceType Open Access Repository
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StartPage 99
SubjectTerms Bipolar disorder
Convulsions & seizures
Diaries
Drug dosages
Epilepsy
Mental disorders
Pregnancy
Research Papers
Studies
Womens health
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Title Model‐based lamotrigine clearance changes during pregnancy: clinical implication
URI https://onlinelibrary.wiley.com/doi/abs/10.1002%2Facn3.29
https://www.ncbi.nlm.nih.gov/pubmed/24883336
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