Tiagabine-HCI (Gabitril((R))) as comedication in the treatment of epilepsy

Tiagabine-hydrochloricle (HCl) is a newly developed antiepileptic drug. In this study it was used as a co-drug in the treatment of patients with epile psy resistant to previous anticonvulsant medication. Primary target criteri a of the study were tolerability and compliance during treatment with Tiaga bine-HCl. Furthermore, its anticonvulsant effect was documented. Patients a nd methods: We included 711 patients with epilepsy (374 men and 337 women) with a mean age of 38.5 +/- 14.9 years. Carbamazepine and valproate were th e most common drugs to which Tiagabine-HCL was added. In 48.8% of patients Tiagabine-HCL was added to two or more antiepileptic drugs. Severity of sei zures, cognitive functions and adverse events were documented prior to ther apy with Tiagabine-HCL and during the follow-up period. Results: Focal seiz ures occurred in 574 patients (117 patients with simple focal, 269 patients with complex focal and 188 patients with secondary generalized seizures). Seizures were classified as primarily generalized in 100 patients. In 37 pa tients seizures could not be classified as focal or generalized. The median daily dose of Tiagabin-HCl was 15 mg b.i.d. The average duration of treatm ent was 96.2 +/- 43.5 days, the average monthly frequency of seizures was 4 .5 seizures prior to treatment with Tiagabine-HCl. Median monthly seizure f requency decreased to 2.0 during therapy with Tiagabin-HCl. At the end of t he observation period 12.3% of the patients remained free from seizures. In 62% of patients seizure frequency decreased by at least 50%. Severity of s eizures diminished in 54% of patients, it remained unchanged in 28.1% and s eizures were more severe in 3.7% of patients. Tiagabin-HCl demonstrated an anticonvulsant effect in the treatment of both focal and generalized seizur es. Adverse events were reported in 91 patients (12.8%) mostly affecting th e central and peripheral nervous system. Serious side effects were noticed in 1% of patients. Nonconvulsive status epileptici occurred in 2 patients. During comedication with Tiagabin-HCL cognitive functions improved in 29.1% of patients, remained unchanged in 55.3% and worsened in 3.5% of patients. Conclusions: Tiagabin-HCl proved to be an effective and well tolerated ant iepileptic drug in the add-on treatment of epilepsy with focal and generali zed seizures.