Abstracts

Rationale: 20-30% of patients with epilepsy still remain refractory to medical treatment, though big effort was done in last two decades in developping new drugs. The efectivity and safety premarketing data are usually obtained from time limited studies. Informations about long-term utility of new drugs are usually obtained from extension phases of this studies, and from postmarketing real clinical praxis data also. The need of new antiepileptic drugs (AEDs) is still declared as actuall, efficacy and tolerability data about the newest are still incomplete. Methods: We prospectivelly followed -up and analysed data in clinical cohort of 50 outpatients (21 men and 29 women) with refractory partial epilepsy visiting tertiary epilepsy centre in University Hospital in Bratislava Slovakia after 36 month treatment with lacosamide (LCS) as add-on therapy. Subgroup of 40 patients were observed for 48 month and subgroup of 36 patients for 54 month . Mean age in this group of patients was 35,6years (20-84y), mean duration of epilepsy 18,4 years(2-47y). 30/50 patients (60%) used before LCS 5 or more AEDs, which is known risk factor for farmacoresistance. The mean used therapeutic dose in our patients was 280,6mg of LCS per day. The frequency of seiures was checked in diares. The efficacy was calculated as responder rate (at minimum 50% reduction in seizure frequency), retention rate, the portion of seizure free (SF) patients was also calculated. Results: Retention rates in this different goups of patients were 50% after 54 and 48 month, and 58% after 36month. Responder rates were 44,4% after 54month, 45% after 48 month and 48 % after 36month. Patients, who became seizure free after adding LCS, remain seizure free (SF) for next period steadily: 10%SF after 36 and 48 month, 11,1% after 54 month ( table 1). SF patients were treated before LCS with less than 4 AEDs, in the patients treated with more than 5 AEDs before LCS none became seizure free. Afxter 36 month in 18% (9/50) of patients LCS was withdrawn due to intolerable side effects, and the rest (24%) due to lack of efficacy. The most often seen adverse events were dizziness and instabile gate, seizure aggravation, diplopia and headache. Isolated patients complained about fatigue, tremor, diarrhoe, depression, one patient with suicidal ideations. No sever idiosyncratic reaction was seen in our patients. Conclusions: Our results are compatible with other long-term follow-up data of LCS as ad-on therapy in refractory partial epilepsy, and seems to be promising from the point of view of the long term treatment of epilepsy. Still, seizure freedom was achieved only in patients treated with less than 4 antiepileptics before LCS administration. LCS has got potential to be used in long term antiepileptic therapy, the highest withdrawal rate of the drug could be expected in the first months of the treatment, and in the patients, who respond from the beggining, one can expect long term efficacy.