Tiagabine therapy for complex partial seizures. A dose-frequency study. The Tiagabine Study Group
R. C. Sachdeo, R. F. Leroy, G. L. Krauss, M. E. Drake Jr, P. M. Green, I. E. Leppik, V. S. Shu, G. L. Ringham and K. W. Sommerville
Department of Neurology, University of Medicine and Dentistry of New Jersey, New Brunswick 08901-2160, USA.
OBJECTIVE: To evaluate the efficacy and safety of 2 regimens of tiagabine
as add-on therapy for patients with complex partial seizures (CPSs) that
are refractory to other treatment. DESIGN: Randomized, double-blind,
placebo-controlled, add-on, parallel-group trial with an 8-week baseline
period, 12-week experimental period (4 weeks of dose titration and 8 weeks
of fixed-dose therapy), and 4-week termination period. SETTING: Twenty-six
centers throughout the United States. PATIENTS: Three hundred fifty-one
patients were enrolled, 318 were entered in the double-blind period, and
271 completed the study. INTERVENTIONS: Tiagabine, 16 mg 2 times per day
(106 patients); tiagabine, 8 mg 4 times daily (105 patients); and placebo
(107 patients). The doses of tiagabine were titrated in 3 steps to the
fixed dose. MAIN OUTCOME MEASURE: The median change in the 4-week rate of
CPSs from baseline to experimental period. RESULTS: The median change from
baseline was -1.6 CPSs per 4 weeks in the group of patients who were given
tiagabine 2 times per day, and it was -1.2 CPSs in the group of patients
who were given tiagabine 4 time per day (P = .06 and P = .02, respectively,
compared with placebo). The 4-week seizure frequency was reduced by 50% or
more in 31% of the patients who were given tiagabine 2 times per day and in
27% of the patients who were given tiagabine 4 times per day vs 10% of the
placebo-treated patients (P < or = .001 for each tiagabine-treated group
compared with the placebo group). The most frequent adverse events involved
the central nervous system and occurred in comparable proportions in the 3
treatment groups. Similar proportions of patients discontinued the study
prematurely for adverse events. CONCLUSIONS: Tiagabine administered 2 and 4
times daily as add-on pharmacotherapy was effective in reducing CPSs in
patients with epilepsy whose conditions were refractory to treatment with
other antiepileptic agents, and it was well tolerated.
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