Abstracts

To analyse dose dependent CNS adverse effects (CNS-AE) of new antiepileptic drugs (AEDs) trough an evaluation of key double-blind studies., we selected all placebo-controlled clinical studies with new AEDs. From each study we extracted the number of patients who complained of CNS-AEs when treated with the active drug (divided for different dose levels) or placebo. For each CNS-AE we calculated the percentage of CNS-AE complaining patients (under treatment or placebo) only from those studies in which the frequency of that CNS-AE was reported. Than we calculated the complaint rate of each CNS-AE (percent of CNS-AE patients under active treatment minus the percent of CNS-AE from patients receiving placebo) (Cramer et al., Epilepsia 1999; 40:590-600). Finally, a summary complaint score (SCS) was calculated for different class of CNS-AEs., SCS for 4 class of CNS-AEs: somnolence, tremor, vestibulocerebellar (ataxia, dizziness, diplopia, blurred vision and gait incoordination) and cognitive are reported in the order.
Gabapentin: 9,6%, 2,3%, 21%, 0%; Lamotrigine: 0%, 0%, 69%, 0%; Levetiracetam: 7%, 0%, 7%, 0%; Pregabalin: 11,6%, 4%, 41%, 9%; Oxcarbazepine: 14,8%, 4,6%, 76%, 0%; Tiagabine: 0%, 26%, 17%, 5%; Topiramate: 30,3%, 0%, 94%, 67,8%; Zonisamide: 6,3%, 0%, 9%, 0%.
From the inspection of data, a relation between dose level and the above reported CNS-AEs was observed in some cases which will be reported., This analysis gives a clear profile of CNS tolerability of various new AEDSs. Overall, levetiracetam had the best profile., (Supported by a grant from the [quot]Ente Cassa di Risparmio di Firenze[quot], Florence, Italy.)