Abstracts

Rationale: Levetiracetam (LEV) is considered to be a generally well-tolerated antiepileptic drug however limited data is available to describe the tolerability in different racial groups. Previously reported clinical trials were conducted in predominantly white patients. This retrospective review will evaluate the use and adverse event (AE) profile of LEV in black patients admitted to Detroit Receiving Hospital.Methods: Single-center, retrospective analysis of black patients receiving LEV during a 1-year period. Charts were reviewed for admission diagnosis, medication and seizure history, pertinent baseline and inpatient laboratory values, and medication therapy during hospital stay. Adverse effects were documented and graded using the Naranjo algorithm. The adverse event rates in this cohort were compared to adverse events reported in previous clinical trials.Results: 96 patients were identified. They were 51% male with a median age 50 (range 18-85) and 89% with a history of a seizure disorder. In the patients with an identified seizure type the most common were complex partial (17%) and generalized tonic-clonic (18%). The majority of patients were admitted due to acute seizure/status epilepticus (40%) with 62% receiving LEV prior to admission. Of the 36 patients who started LEV during hospitalization, 8% received a median loading dose of 1000 mg and only 5.5% had the maintenance dose titrated. The most common total LEV dose was 1000mg/day (59%). LEV monotherapy was utilized in 41% of the cohort. Phenytoin (39%) was the most commonly administered concomitant antiepileptic drug (AED). Overall 39.6% of patients experienced an adverse event (AE). The most commonly reported AE were aggression/hostility (12.5%), confusion (11%) and somnolence/lethargy (10%). Based upon the Naranjo algorithm the majority of the AE were classified as possibly related to LEV. These events were predominately mild to moderate in nature with only one patient requiring LEV discontinuation due to excessive somnolence. While 4 patients had their LEV dosage decreased due to AE. No laboratory abnormalities were identified. Table 1 shows a profile of adverse events based upon patients receiving LEV prior to admission compared to those initiated on LEV during the hospitalization. No risk factors for adverse events in this cohort could be identified based upon logistic regression. EEG results were available for 29% of the cohort with 54% showing no epileptiform activity.Conclusions: Overall LEV is well tolerated in this cohort of black patients with adverse events occurring in rates similar to the non-black population except for aggression/hostility which occurred in 12.5% of this cohort compared to 2% in other populations. No variables were associated with the occurrence of AE in our cohort. This report provides an important source of information about the tolerability of LEV in black patients.