Abstracts

Pregabalin is a recently licensed antiepileptic drug, which promises, from study datas, an substantial improvement of drug therapy. We report outcome and tolerability datas about 58 patients treated add-on with Pregabalin under clinical conditions. This is a prospective open label observational study. Datas were collected prospectively by patient charts and seizure protocols. All of these patients were drug resistant under usual drug regiment. 44% of the patient had one drug, 44% two drugs and 12% three drugs. The predominant basic drugs were Lamotrigin, Carbamazepin, Levetiracetam and Oxcarbazepin. All patients had focal epilepsies either temporal or frontal. The average observational period was 14 weeks. 49% of the patients were responder with 19% seizure free patients. On the other hand 19% of the patients had worsening of the seizure course either with increase of seizure frequency or change of seizure semiology. In 16 cases weight gain was the predominant adverse event, associated with severe oedema in 1/3 of these cases. 11 cases had psychic adverse events predominantly with irritability and aggressiveness. 13 cases suffered from dizziness and deplopia. Only two types of side effects dizziness and psychic events showed a slide correlation with the co-medication with Oxcarbazepin and Carbamazepin. 1/3 of the patients withdraw Pregabalin during the average observation period of 14 weeks. 2/3 of them because of inefficacy and only 1/3 because of adverse events. There was a linear correlation between Pregabalin dosages and serum concentration, but with a large variation. There was no correlation between serum level and weight gain, but a correlation between serum level and dizziness. Pregabalin shows an additional improvement of drug therapy in so far drug resistant cases. In respect to tolerability, weight gain and severe oedema might be the predominant problems. For these AE there is no correlation with the basic co-medication. So far we are missing predictive factors. Psychic side effects seems to be much more correlated with the co-medication with Oxcarbazepin and Carbamazepin but we are also still missing other predictive factors. In general this drug seems to be well tolerable, only 10% withdraw the drug because of side effects.