Abstracts

RATIONALE: Oxcarbazepine (OXC) is a newer anti-epileptic drug (AED) approved for monotherapy and polytherapy for partial epilepsy. OXC has been described as having fewer associated adverse events (AEs) than carbamazepine (CBZ). To explore the role of OXC and CBZ in [dsquote]real world[dsquote] epilepsy therapy, we compared spontaneously-reported AEs for both medications from the FDA[ssquote]s Adverse Event Reporting System (AERS).
METHODS: Data from the AERS were analyzed from the second quarter of 2000 (April 1 - June 30 2000). All reported AEs in which CBZ or OXC was specified as the primary or concomitant agent were included. To evaluate the costs of AE treatment, we matched symptoms and outcomes from hospitalizations in the AERS with data from the 1997 National Hospital Discharge Database to project duration of hospitalization. An average U.S. per diem cost was applied to days of hospitalization to determine total hospitalization cost per reported AE.
RESULTS: The hospitalization rate for reported OXC AEs was 1.8% lower than that for reported CBZ AEs. Among all patients (those hospitalized and those not hospitalized), the average duration of hospitalization for reported CBZ AEs was 5.58 days, while the duration for reported OXC AEs was 4.98 days, a reduction of 10.8%. This difference (0.60 hospital days) corresponds to approximately $600 per adverse event. Among only patients requiring hospitalization for AEs, the mean length of stay per reported CBZ AE is 7.35 days versus 6.69 days per reported OXC AE (difference of 0.66 days, reduction of 9.0%).
CONCLUSIONS: These results indicate that OXC therapy results in fewer reported AEs requiring hospitalization than does CBZ therapy and the OXC hospitalizations are shorter and less costly.
Support: This study was funded by the Novartis Pharmaceuticals Corporation.
Disclosure: Salary - Novartis Pharmaceuticals Corporation; Grant - Novartis Pharmaceuticals Corporation; Consulting - Novartis Pharmaceuticals Corporation