Abstracts

RATIONALE: Levetiracetam (LEV) has been studied in a large population since the 1980 s, only some of which were epilepsy patients included in well controlled clinical studies. The adverse experience (AE) profile has been characterized as mild to moderate. An examination of the serious adverse experience (SAE) profile including the SUDEP rate was undertaken. METHODS: Overall exposure data was reviewed. Treatment emergent SAEs were reviewed for the well controlled add-on studies. The SUDEP rate is reported and compared to other reports. RESULTS: A total of 3347 patients had been exposed to LEV from 1980 through November 1998 (1537 placebo). When exposure is reported in person years, for all studies, LEV 2449.0 (placebo 243.4) person years. For epilepsy patients, LEV 2257.6 (placebo 152.1) person years. The most frequently reported SAEs in the well controlled add-on studies among LEV-treated (n=769) patients were somnolence (3.1%), asthenia (1.6%), convulsion (1.6%), and grand mal convulsion (1.0%). Accidental injury and headache were also among the most common SAEs in patients receiving LEV (1.4%) and (1.7%) respectively, however, these were more common in placebo-treated (n=439) patients (2.1%). The rate of SUDEP (which includes definite, probable, and possible) in the overall program was 3.7. The SUDEP rate for LEV was 3.54 (placebo 6.58). CONCLUSIONS: The number of patients exposed to LEV overall far exceeds the epilepsy population studied in well controlled studies, however majority of person years exposure was from the well controlled studies. The small number of SAEs confirms the mild to moderate LEV AE profile. The LEV SUDEP rate is less than or similar to that seen for recently approved AEDs or devices.