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Tiagabine Monotherapy in the Treatment of Partial Epilepsy
Author(s) -
Schachter Steven C.
Publication year - 1995
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1157.1995.tb06011.x
Subject(s) - tiagabine , medicine , discontinuation , placebo , epilepsy , adverse effect , dose ranging study , anticonvulsant , partial seizures , anesthesia , refractory (planetary science) , randomized controlled trial , double blind , physics , pathology , psychiatry , astrobiology , alternative medicine
Summary: Three studies were conducted to assess tiagabine (TGB) hydrochloride monotherapy in patients with partial seizures. The first was a double‐blind, placebo‐controlled trial of 11 patients (seven TGB, four placebo) undergoing evaluation for epilepsy surgery. Baseline antiepileptic drug (AED) therapy was discontinued abruptly before monotherapy. Although 24‐h seizure rates increased during monotherapy in both groups, patients receiving TGB experienced fewer seizures than placebo patients. Subsequent studies (an open‐label, dose‐ranging study; n = 31 and a double‐blind, randomized comparison of 6 and 36 mg/day TGB; n = 102 and 96, respectively) involved discontinuation of baseline AEDs. In the dose‐ranging study, 19 of 31 patients (61%) converted to TGB monotherapy, with a mean final dose of 38.4 mg/day (range 24–54 mg/day) in those who completed the study ( n = 12). In the low‐ vs. high‐dosage study, median 4‐week complex partial seizure rates decreased significantly in patients from both dose groups who completed the monotherapy period ( p <0.05 compared with baseline). In the intent‐to‐treat analysis, significantly more patients in the high‐dose group experienced a reduction in seizures of at least 50% compared with the low‐dose group ( p = 0.038). Overall, the types of adverse events with TGB monotherapy were similar to those observed in add‐on trials. These initial trials in difficult‐to‐treat epilepsy patients indicate that TGB monotherapy may provide a new approach to the treatment of patients with partial seizures refractory to other AEDs.