Tiagabine: The Safety Landscape

Summary: Tiagabine (TGB) hydrochloride is a potential new antiepileptic drug (AED) undergoing clinical development. Experience in humans amounts to 1,810 patient‐years of exposure. TGB was found to be tolerated in an integrated safety analysis of five double‐blind, add‐on therapy trials involving approximately 1,000 patients with epilepsy with difficult‐to‐control seizures with existing AEDs. Discontinuation resulting from adverse events were infrequent, occurring in 15% of patients receiving TGB compared to 5% receiving placebo. The most frequently reported adverse event was dizziness, which was usually transient and did not require medical intervention. Adverse events that were statistically significantly more common with TGB than placebo were dizziness, asthenia, nervousness, tremor, diarrhea, and depression (not major depression). Adverse events were usually mild to moderate in severity and transient, and most were associated with dose titration. The incidence, type, and severity of adverse events in long‐term studies were comparable with those in short‐term studies. Serious adverse events were uncommon and no idiosyncratic events were reported.