International experience with tiagabine add-on therapy.
Tiagabine (TGB) hydrochloride is a novel antiepileptic drug (AED) that is a potent and specific inhibitor of gamma-aminobutyric acid (GABA) uptake into glial and neuronal elements. In accordance with medical and regulatory standards, the clinical development program for TGB as an AED has assessed the value of TGB in add-on treatment, focusing mainly on partial seizures, including secondarily generalized seizures. Five add-on, placebo-controlled trials and six noncomparative, open-label, long-term multicenter trials have been or are being conducted in Australia, Europe, and the U.S.A. The results of these trials, involving 2,261 patients, indicate that TGB has efficacy as add-on therapy in patients with epilepsy difficult to control with existing AEDs. Efficacy of TGB is also sustained with long-term treatment. A clear dose-response has been demonstrated, and the minimal effective dose level is 30 mg. TGB is also tolerated, and with long-term therapy no new or more severe types of adverse events develop. These studies have included a wide age range of patients, including adolescents and the elderly.
Ben-Menachem
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Department of Clinical Neuroscience, Sahlgren Hospital, Göteborg, Sweden.
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000927:Anticonvulsants / Q000627:therapeutic use*; D001315:Australia; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005060:Europe; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009557:Nipecotic Acids / Q000627:therapeutic use*; D010919:Placebos; D000078308:Tiagabine; D016896:Treatment Outcome; D014481:United States; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*
D000927:Anticonvulsants; D009557:Nipecotic Acids; D010919:Placebos; D005680:gamma-Aminobutyric Acid; D000078308:Tiagabine