Abstracts

RATIONALE: Quality of life (QOL) in studies of epilepsy is typically measured solely as the reduction in seizures and is in need of a more encompassing approach. Quality of life can be independent of seizure frequency. Comparison between treatment groups becomes more meaningful when using a multi-faceted approach.
METHODS: Data measuring quality of life were pooled across four clinical trial studies and compared for effects within treatment groups. Basic demographic attributes and 31 questions from the Quality of Life in Epilepsy instrument were used to assess a broad range of health and well-being variables from 651 patients. Data were gathered at two-points in time; at screen and at the end of a 32-week treatment.
RESULTS: We identified 651 patients with epilepsy using the following treatments: 419 lamotrigine, 158 valproate, 70 carbamazepine, and 4 phenytoin. Comparisons were made between the lamotrigine (N= 419) and the conventional AED group (i.e. all others, N=232) across several QOL indicators including seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, health state, social functioning, and overall scores on quality of life and health. Across all nine comparisons, the lamotrigine group[ssquote]s mean change from baseline (screen) scores were more favorable or equal to the other conventional anti-epileptic drugs (AED) group on six variables. Of these, statistical differences were found on two important QOL indicators: energy/fatigue (p=0.05) and medication effects (p=0.002). The conventional AED group did not obtain statistical difference on any QOL indicator when compared to the lamotrigine group. On the important indicator, seizure worry, the lamotrigine group had a lower mean change score but it did not obtain statistical significance.
CONCLUSIONS: There is an increasing awareness of the need for broad-based QOL measures in studies investigating treatment for epilepsy. It has been argued that studies looking only at the frequency of seizures as the sole measure of QOL may be missing other important well-being measures. In these clinical trials data, comparisons were made across several dimensions of QOL between those taking lamotrigine and those taking more conventional AEDs. The results indicate that persons with epilepsy taking lamotrigine either faired equally to those on other treatment medications or had better outcomes on QOL measures; energy/fatigue and medication effects.
[Supported by: GlaxoSmithKline]; (Disclosure: Salary - GlaxoSmithKline, Stock - GlaxoSmithKline)