Comparison of Antiseizure Medication Concentrations Measured Within and Outside a Central Laboratory
Abstract number :
2.239
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2022
Submission ID :
2204839
Source :
www.aesnet.org
Presentation date :
12/4/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:26 AM
Authors :
Charul Avachat, MS – University of Minnesota, College of Pharmacy; Page Pennell, MD, FAES – University of Pittsburgh School of Medicine; Kimford Meador, MD, FAAN, FAES, FRCPE – Stanford University School of Medicine; Abigail Matthews, PhD – The EMMES Corporation; Carrie Brown, MS, MA – The EMMES Corporation; Chelsea Robalino, MSTAT – The EMMES Corporation; Angela Birnbaum, Ph.D., FAES – University of Minnesota
Rationale: Clinical samples collected for therapeutic drug monitoring are measured by designated laboratories and vary across institutions. Multi-site clinical trials often employ a central laboratory to perform bioanalyses to decrease the inter-laboratory variability and standardize measurements within individuals. Our objective was to compare antiseizure medication (ASM) blood concentrations measured within and outside of a central laboratory setting enabling characterization of variability associated with bioanalytical sample processing.
Methods: Data from women enrolled in the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study were included. Seven blood samples were collected over seven time points in pregnant women (during and up to 9 months after delivery) and nonpregnant women (over 18 months) who were between the ages of 14 and 45 years. Plasma samples collected during the study were split into two sets: 1) one frozen and shipped on dry ice to the MONEAD central lab (University of Minnesota) for periodic batch analyses and 2) one sent to the respective clinical site laboratory for immediate analysis. Samples from an individual subject were batched and run on one analytical assay within the central laboratory to decrease inter-assay variability. Samples were measured for lamotrigine (LTG), levetiracetam (LEV), carbamazepine (CBZ), oxcarbazepine (OXC), zonisamide (ZNS), lacosamide (LCM) and topiramate (TPM) depending on treatment. The percentage difference in the concentrations obtained in each laboratory (central vs clinical) was calculated. Paired t-test was used to compare the concentration results between laboratories using R version 4.0.3. A p-value < 0.05 was considered statistically significant.
Anti-seizure Medications