Dataset Information

Data on the relationship between lamotrigine and levetiracetam serum/plasma levels and toxicity: Experience at an academic medical center

ABSTRACT: Lamotrigine and levetiracetam are second-generation anti-epileptic drugs used for the management of seizure disorders and some other medical conditions. In the related research article using retrospective data from an academic medical center, we analyzed 5046 samples originating from 1930 unique patients that had lamotrigine drug levels performed on serum/plasma and 4359 samples from 2451 patients that had levetiracetam drug levels performed. The data in this article provides the patient demographic, clinical location at time of drug level, and specific lamotrigine or levetiracetam serum/plasma drug level for all patients. For those instances with lamotrigine drug level greater than 14.0 mg/L or levetiracetam drug level of 80 mg/L or higher, additional data from chart review includes: indication for ordering the drug level, two main presenting signs or symptoms at time of drug level, timing of drug level (random, trough, peak, or unknown), changes in drug dosing following the drug level, concomitant therapy with valproic acid (lamotrigine only), and details related to drug overdose (if applicable). The analyzed data is provided in the supplementary tables included in this article. Volumes of test ordering by year is included in a figure. The dataset reported is related to the research article entitled “Correlation of Elevated Lamotrigine and Levetiracetam Serum/Plasma Levels with Toxicity: A Long-Term Retrospective Review at an Academic Medical Center” [K. E. Wood, K. L. Palmer, M.D. Krasowski, Correlation of elevated lamotrigine and levetiracetam serum/plasma levels with toxicity: A long-term retrospective review at an academic medical center, Toxicol. Rep. (2021) 8:1592-1598]

SUBMITTER: Wood K

PROVIDER: S-EPMC8603012 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Amidst the therapeutic void at the onset of the COVID-19 pandemic, a critical mass of scientific and clinical interest coalesced around COVID-19 convalescent plasma (CCP). To date, the CCP literature has focused largely on safety and efficacy outcomes, but little on implementation outcomes or experience. Expert opinion suggests that if CCP has a role in COVID-19 treatment, it is early in the disease course, and it must deliver a sufficiently high titer of neutralizing antibodies (nAb). Missing in the literature are comprehensive evaluations of how local CCP programs were implemented as part of pandemic preparedness and response, including considerations of the core components and personnel required to meet demand with adequately qualified CCP in a timely and sustained manner. To address this gap, we conducted an evaluation of a local CCP program at a large U.S. academic medical center, the University of North Carolina Medical Center (UNCMC), and patterned our evaluation around the dimensions of the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to systematically describe key implementation-relevant metrics. We aligned our evaluation with program goals of reaching the target population with severe or critical COVID-19, integrating into the structure of the hospital-wide pandemic response, adapting to shifting landscapes, and sustaining the program over time during a compassionate use expanded access program (EAP) era and a randomized controlled trial (RCT) era. During the EAP era, the UNCMC CCP program was associated with faster CCP infusion after admission compared with contemporaneous affiliate hospitals without a local program: median 29.6 hours (interquartile range, IQR: 21.2-48.1) for the UNCMC CCP program versus 47.6 hours (IQR 32.6-71.6) for affiliate hospitals; (P<0.0001). Sixty-eight of 87 CCP recipients in the EAP (78.2%) received CCP containing the FDA recommended minimum nAb titer of ≥1:160. CCP delivery to hospitalized patients operated with equal efficiency regardless of receiving treatment via a RCT or a compassionate-use mechanism. It was found that in a highly resourced academic medical center, rapid implementation of a local CCP collection, treatment, and clinical trial program could be achieved through re-deployment of highly trained laboratory and clinical personnel. These data provide important pragmatic considerations critical for health systems considering the use of CCP as part of an integrated pandemic response.

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Data on the relationship between lamotrigine and levetiracetam serum/plasma levels and toxicity: Experience at an academic medical center

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