Evidence map›Paper›PMID 24883336›Full record

ArticleAnnals of clinical and translational neurology2014

MODEL-BASED LAMOTRIGINE CLEARANCE CHANGES DURING PREGNANCY: CLINICAL IMPLICATION.

Akshanth R Polepally, Page B Pennell, Richard C Brundage, Zachary N Stowe, D Jeffrey Newport, Adele C Viguera, James C Ritchie, Angela K Birnbaum

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Annals of clinical and translational neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03774641 (A Pilot Study of Prophylactic Management of Lamotrigine for Bipolar Disorder in Pregnant Women), which is not on this map. Cited by 40 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 4 pooled it
9.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03774641 completednot on this mapstarted 2018, after this paper: background citation

A Pilot Study of Prophylactic Management of Lamotrigine for Bipolar Disorder in Pregnant Women

TypeobservationalSponsorJohns Hopkins UniversityRan2018 to 2024Enrolled10ConditionsBipolar Disorder, Major Depressive Disorder, Schizo Affective DisorderArmsLamictal
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 4 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Observational
  7. Observational
  8. Article
  9. Observational
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Levetiracetam, lamotrigine and carbamazepine: which monotherapy during pregnancy?Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Akshanth R PolepallyExperimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota.
Page B PennellDepartment of Neurology and Division of Women's Health at Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Richard C BrundageExperimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota.
Zachary N StoweDepartment of Psychiatry, Pediatrics, and Obstetrics & Gynecology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
D Jeffrey NewportDepartments of Psychiatry and Obstetrics & Gynecology, The Ohio State University College of Medicine, Columbus, Ohio ; Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia.
Adele C VigueraDepartment of Psychiatry, Cleveland Clinic, Cleveland, Ohio.
James C RitchieDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia ; Department of Pathology, Emory University School of Medicine.
Angela K BirnbaumExperimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota.
University of Minnesota · USEmory University · USCleveland Clinic · USHarvard University · USUniversity of Arkansas for Medical Sciences · US

Funding

Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)U01NS038455 · NINDS · STANFORD UNIVERSITY · PI MATTHEWS, ABIGAIL GOREN, MEADOR, KIMFORD J · 2012 to 2022
$27.7M
X LINKED NYSTAGMUS SYNDROME WITH FEATURES OF ALBINISMM01RR000039 · NCRR · EMORY UNIVERSITY · PI VACCARINO, VIOLA · 1985 to 2007
$21.3M
Mood and Anxiety Disorders in Pregnancy and LactationP50MH068036 · NIMH · EMORY UNIVERSITY · PI STOWE, ZACHARY N · 2002 to 2006
$6.1M
Bipolar Disorder in Pregnancy: Predictors of MorbidityR01MH071762 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI VIGUERA, ADELE CASALS · 2005 to 2009
$2.1M
Bipolar Disorder in Pregnancy: Predictors of MorbidityR01MH071531 · NIMH · EMORY UNIVERSITY · PI NEWPORT, DONALD JEFFREY · 2005 to 2009
$2.1M
NCRR NIH HHS M01 RR000039NIMH NIH HHS P50 MH068036NIMH NIH HHS R01 MH071531NIMH NIH HHS R01 MH071762NINDS NIH HHS U01 NS038455
6 · The paper itself

Abstract

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 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.

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.

Identifiers

PMID24883336
PMCPMC4038031
OpenAlexW2049517853

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.