Fenfluramine effectively reduces seizure in patients with Dravet Syndrome: Study

USA: Fenfluramine is well-tolerated and helps to control seizures for a long period in patients with Dravet syndrome, suggests a recent study in the journal Epilepsia.

Recent randomized, placebo‐controlled clinical trials have shown fenfluramine to provide significant reductions in convulsive seizure frequency in children and adolescents (aged 2‐18 years) with Dravet syndrome. The objective of this study by Joseph Sullivan, University of California San Francisco, San Francisco, CA, USA, and colleagues was to assess longer‐term safety and efficacy of fenfluramine in patients who completed one of the double‐blind studies and entered an open‐label extension (OLE) study.

232 patients enrolled in the OLE study were initiated fenfluramine at 0.2 mg/kg/d regardless of their treatment assignment in the double‐blind study. After 4 weeks, the fenfluramine dose could be titrated based on efficacy and tolerability to maximum of 0.7 mg/kg/d (absolute maximum 27 mg/d) or maximum of 0.4 mg/kg/d (absolute maximum 17 mg/d) in patients receiving concomitant stiripentol. The number and type of seizures were recorded daily in an electronic diary, and safety, including echocardiography, was assessed at Months 1, 2, and 3, and at 3‐month intervals thereafter.