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Tiagabine for complex partial seizures: a randomized, add-on, dose-response trial
B M Uthman1, A J Rowan, P A Ahmann
1Veterans Affairs Medical Center, and the Department of Neurology and Brain Institute, University of Florida College of Medicine, Gainesville 32608, USA.
Archives of Neurology
|January 27, 1998
Summary
Tiagabine effectively reduced complex partial seizures (CPS) in a dose-dependent manner. This antiepileptic drug (AED) demonstrated good tolerability as an add-on therapy for patients with intractable CPS.
Area of Science:
- Neurology
- Pharmacology
Background:
- Complex partial seizures (CPS) are a common form of epilepsy.
- Current treatments for intractable CPS have limitations.
- Tiagabine is an antiepileptic drug (AED) that inhibits gamma-aminobutyric acid (GABA) uptake.
Purpose of the Study:
- To evaluate the efficacy and tolerability of tiagabine as adjunctive therapy for patients with intractable CPS.
- To compare three different doses of tiagabine against a placebo.
Main Methods:
- A randomized, double-blind, placebo-controlled study was conducted across 21 US medical centers.
- 297 patients with CPS, on stable antiepileptic drug regimens, received either placebo or tiagabine (16, 32, or 56 mg daily) for 20 weeks.
- The primary outcome measure was the median change in 4-week CPS frequency.
Main Results:
- Significant reductions in CPS frequency were observed with tiagabine at 32 mg (-2.2) and 56 mg (-2.8) compared to placebo (-0.7).
- A 50% or greater reduction in CPS frequency was achieved by 20% (32 mg) and 29% (56 mg) of patients, versus 4% in the placebo group.
- Adverse events were generally similar, with increased dizziness, tremor, abnormal thinking, and depressed mood noted at specific tiagabine doses.
Conclusions:
- Tiagabine is an effective and well-tolerated adjunctive treatment for patients with intractable complex partial seizures.
- A clear dose-response relationship was established for tiagabine in treating CPS.
- Further research may explore optimal dosing strategies and long-term outcomes.