Short-Term Effectiveness and Tolerability of Vigabatrin Therapy in Infantile Epileptic Spasms Syndrome.

The study evaluated the short-term effectiveness and tolerability of vigabatrin therapy in children with infantile epileptic spasms syndrome (IESS). Children with IESS were enrolled within two weeks of initiation of vigabatrin and prospectively followed up to 12 wk for complete cessation of epileptic spasms (ES) and occurrence of adverse events. Of 107 children studied, there was a preponderance of structural etiology (82.2%) and male sex (69.2%). Thirty percent of children achieved a complete cessation of ES for at least four weeks at a median dose of 95 mg/kg/d (Q1, Q3: 50, 125). Among responders, 84.4% achieved cessation of ES within two weeks of initiation of therapy. 12.5% of children had a relapse over a 12-wk follow-up. Thirteen percent of children had adverse events, drowsiness being the most common (9.3%). The present study demonstrated modest short-term clinical effectiveness and tolerability of vigabatrin therapy in children with hormonal-therapy-resistant IESS.