Abstract Details

Title Carbamazepine Clearance and Seizure Control during Pregnancy

Topic Epilepsy

Presentation(s) (-)

Poster/Presentation
Number 002

Objective

Background CBZ is commonly utilized during pregnancy in women with epilepsy (WWE). There are conflicting data on CBZ clearance during pregnancy, ranging from no change to a modest increase in clearance. Current guidelines state monitoring of CBZ levels during pregnancy should be considered.

Design/Methods Prospective observational study. Following informed consent, serum samples were collected throughout pregnancy; preconception and postpartum (>6 weeks) samples were obtained as non-pregnant baseline. Assays were completed in batches in a single lab. Concentrations of total and free CBZ and CBZ-epoxide were obtained to compare the median apparent oral clearances [(mg/kg)/(mg/L)] for each compound, using Wilcoxon with Bonferroni correction, between baseline and each trimester (TM1, TM2, TM3) and between trimesters. Seizure frequency was examined for association with changes in CBZ concentrations.

Results 16 pregnancies from 13 WWE on CBZ and no interacting medications provided 152 serum samples. Median clearances [(mg/kg)/(mg/L)] for total CBZ were 1.57 (baseline), 1.35 (TM1), 1.36 (TM2), and 1.74 (TM3); free CBZ clearances were 8.34 (baseline), 4.7(TM1), 7.67(TM2), and 5.71(TM3). Pair-wise comparisons did not show significant change in clearance from baseline relative to any trimester. Adjustment for hours-post-dose did not alter results. Total and free CBZ-epoxide clearance changes were also non-significant. Seizure data from 9 women on CBZ monotherapy demonstrated that 4 had worsened seizure control during 1-2 months of pregnancy compared to baseline. However, these months did not correspond to lower total or free CBZ or CBZ-epoxide concentrations.

Conclusions The results from this small prospective cohort did not demonstrate clinically significant increases in the clearance of total or free CBZ or CBZ-epoxide. Therapeutic drug monitoring in pregnancy for CBZ is not supported in this cohort, though confirmation in larger samples is warranted prior to definitive recommendations.

Authors/Disclosures
Emily Johnson, MD (Johns Hopkins Epilepsy Center) PRESENTER	Dr. Johnson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EpiWatch. The institution of Dr. Johnson has received research support from NIH.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Timothy K. Vartanian, MD, PhD (Weill Cornell Medical College)	Dr. Vartanian has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Vartanian has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Vartanian has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Vartanian has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Tisch MS Center. Dr. Vartanian has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen.
Melanee Newman (Emory University School of Medicine)	No disclosure on file
	No disclosure on file
	No disclosure on file

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