Safety of long-term treatment with tiagabine.

Overview

The aim of this study was to evaluate the safety of long-term treatment with tiagabine. We reviewed the case report forms of patients with refractory partial epilepsy who took tiagabine for longer than 6 months in two long-term studies. We classified all adverse events based on severity and persistence, and recorded the dose at onset of each adverse event. We then divided patients into those treated for 6-12 months, 12-24 months and > 24 months. We compared the adverse event profile and change in seizure frequency among the three groups. Forty-two patients took tiagabine for longer than 6 months. The mean duration of treatment was 22.6 months. The mean monthly seizure frequency was 12.7 at baseline and 8.1 at study termination (36% decrease). The most common adverse events were: tiredness (56%), headache (46%), dizziness (44%), visual symptoms (blurring, difficulty focusing, diplopia) (39%), altered mentation (32%), and tremor (31%). The adverse event profile was comparable among the three groups. Seizure frequency was significantly more improved in the > 24 months group. Long-term treatment with tiagabine is well tolerated. The most important predictor of long-term therapy with tiagabine was the degree of seizure improvement.