Abstracts

Pregabalin (PGB) is a new antiepileptic drug, availabe in Europe since February 2005, which has shown, in randomized clinical trials, efficacy and good tolerability as add-on treatment in patients with refractory epilepsy. Our objective was to study the efficacy and tolerability of PGB when used in every day clinical practice to treat refractory patients in two tertiary centers., We retrospectively reviewed 101 patients (60 women, 41 men) who received PGB as add on treatment for refractory seizures, at the Epilepsy Units of Hospital Cl[iacute]nic (Barcelona, Spain) and Hospital Joseph Trueta (Girona, Spain). Mean age was 40 years (16-64), mean time from seizure onset was 22 years (7-53), mean number of concomitant AEDs was 2.8. Most patients had temporal lobe epilepsy (43 patients), followed by frontal lobe epilepsy (29), unlocalized focal epilepsy (23 patients), parieto-occipital epilepsy (4 patients) and multifocal epilepsy (2). Seizures were highly refractory, with a mean number of seizures per month of 48.5. Mean follow up was 8 months (3-14)., Mean PGB dose used was 412.5 mg. Fifty three patients (52%) were responders (had [ge] 50% seizure reduction). A significant number of patients (14, 13.8%) became seizure free. Seizure frequency increased in 4 patients (3.6%). Three patients reported similar number of seizures but less severity (shorter seizures or absence of generalized tonic clonic convulsions).
PGB was generally well tolerated. Sixty per cent of patients reported adverse events, being weight gain [gt] 10% the most frequent, seen in 25 patients (24.7%). Dizziness/ataxia was seen in 14 patients (13.8%). Seven patients (6.9%) displayed lower limb edema not accompanied by metabolic disturbance, and 4 patients (3.9%) had dose-dependent blurred vision. Adverse effects were generally mild to moderate in severity. Twenty two patients discontinued PGB, either because of adverse effects (9 patients), inefficacy (6) or both (7 patients). Prescribing physicians rated 18 patients (17.8%) as [quot]highly improved[quot], 42 patients (41.5%) as [quot]improved[quot], 33 patients (32%) as [quot]unchanged[quot], 6 patients (5.9%) as [quot]worse[quot] and 4 patients as [quot]much worse[quot] (3.9%)., PGB, when used in every day clinical practice, is effective and safe as add-on treatment in refractoy epilepsy. In our series of highly refractory patients, 52% had at least a 50% seizure reduction and 14% of patients became seizure free. Most frequent adverse events were weight gain and dizziness/ataxia. Most patients were rated as highly improved or improved by the prescribing physician.,