Open-Label Assessment of Levetiracetam (LEV) Efficacy and Adverse Effects in a Pediatric Population.
Abstract number :
1.166
Submission category :
Year :
2001
Submission ID :
1184
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
B.F.D. Bourgeois, M.D., Neurology, Children[ssquote]s Hospital, Boston, MA; D.L. Holder, M.D., Neurology, Children[ssquote]s Hospital, Boston, MA; I. Valencia, M.D., Neurology, Children[ssquote]s Hospital, Boston, MA; G.L. Holmes, M.D., Neurology, Childre
RATIONALE: To evaluate the efficacy and adverse effects of LEV in a pediatric population of patients with various seizure types.
METHODS: following the marketing of LEV, all patients who were seen in the Division of Epilepsy and Clinical Neurophysiology at Boston Children[ssquote]s Hospital, and who were prescribed LEV, were entered into the study. All the relevant demographic and clinical data were entered into a database and subsequently analyzed.
RESULTS: Seventy patients were entered, 65 patients with follow-up were entered in the analysis. Age: mean 12.8 years, range 2-34, 9 patients older than 18. Developmental delay in 69%. Mean age at seizure onset 3.7 years. Mean number of previously tried antiepileptic drugs (AEDs): 7.6. Previous epilepsy surgery in 23.1%, vagal nerve stimulator (VNS) in 33.9%, ketogenic diet (KGD) in 18.5%. Other AEDs at time of introduction of LEV: 1 in 30.8%, 2 in 38.5%, 3 in 20.1%, [gt]3 in 9%; VNS alone in 1, KGD in 3 patients. Epilepsy type: 54% localization-related, 46% generalized. Mean duration of follow-up: 5.6 months, range 1-13. In patients with recorded weight, the mean LEV dose was 35 mg/kg/d (7.3-92).
Efficacy: the responder rates ([gte]50% reduction) were: complex partial seizures 10/28 (35.7%); secondarily generalized tonic-clonic seizures 3/6 (50%); primarily generalized tonic-clonic 5/18 (27.8%); generalized tonic 7/20 (35%); drop attacks 1/4 (25%); atypical absences 1/5 (20%); myoclonic 1/8 (12.5%). Seizure-free: 4/65 (2.6%); seizures worse 2/65 (1.3%).
Adverse events occurred in 16 patients (24.6%): behavioral problems in 10 patients (15.4%), severe in 3; lethargy in 4; cognitive slowing in 1; increased appetitie and weight gain in 1; dystonia in 1; nonconvulsive status in 1. LEV was discontinued in 23 patients, in 15 (23.1%) due to lack of efficacy, in 8 (12.3%) due to adverse effects.
CONCLUSIONS: In this group of 65 highly refractory pediatric patients with epilepsy, LEV was remarkably effective against focal onset as well as primarily generalized convulsive seizures (generalized tonic-clonic and tonic). Numbers for other seizure types are still too small for valid assessment. LEV had relatively few side effects. Behavioral abnormalities were by far the single most common adverse effect in this pediatric population.
Support: No funding was received for this study.
Disclosure: Consulting - UCB Pharma; Honoraria - UCB Pharma