Abstracts

Rationale: To evaluate the long term efficacy and tolerability of levetiracetam (LEV) monotherapy for adults patients suffering from focal onset cryptogenic or symptomatic epilepsy. Methods: We studied 65 adult patients, 14-71 years aged (mean 37.6 years), affected by cryptogenic or symptomatic focal onset epilepsies, with partial and/or secondarily generalized seizures. 25 patients, newly diagnosed, received LEV as first line therapy, whereas 40 patients, non responding to another AEDs because inefficacy or side effects, were converted to LEV (21 from CBZ, 6 from PB, 5 from OXC, 5 from VPA, 3 from TPM). We excluded patients with progressive brain disease and patients with “uncountable” (e.g. recurrent cluster) seizures. We considered the following therapeutic outcomes: -Reduction in seizure frequency -Responder rates after 6 months of treatment (proportion of patients with almost 50% reduction in seizure frequency compared to baseline and proportion of patients seizure free) -Retention rates (proportion of patients continuing therapy) after 12 and 18 months -Rate of relapses at 18 months Clinic and demographic data of our sample are summarized in table 1. Results: Reduction in seizure frequency after 6 months of Levetiracetam therapy was high statistically significant (-3 seizures/month = -75%, compared to base-line frequency; p<0.05 or <0.01), without relevant difference between first line and conversion group. After 6 months of treatment we observed 75.4% of responders, 41.5% of patients seizure free (64% in the first line group, 27.5 in conversion group), 24.6% of non responders. Retention Rate after 12 months was 83.1%, without significant difference between two group. Retention Rate after 18 months was 69.2%: 84% in first line group and 60% in conversion group; this difference resulted statistically significant when evaluated with Fischer’s Exact Test (p = 0.05). After 18 months the rate of relapses was 32.0% (8 of 25 patients) in first line group and 67.5% (27 of 40 patients) in the conversion one. These differences resulted highly statistically significant (Fischer’s Exact Test: p<0.01). Main cause of drop out was lack of efficacy (12% of patients in first MT group and 35% in Second line MT one), whereas side effect causing drop out were rare. Side effects were mainly psychic, overall rare, often transient and in all cases reversible. No alteration recurred in laboratory tests. Results are summarized in Table 2 Conclusions: In our sample, also when used in monotherapy, LEV showed low rates of side effects, an excellent safety profile, without any cases of serious advers events, and high responders and retention rates. We doesn’t observe substantial loss of efficacy on long term (18 months) evaluation. We observed better outcome in newly diagnosed patients than in second line patients. This difference reflects the great prevalence of difficult to treat epilepsies in second line group.