WEDNESDAY, Dec. 18, 2019 (HealthDay News) — Among patients with Dravet syndrome, the reduction in frequency of convulsive seizures is greater with fenfluramine than with placebo, according to a study published online Dec. 17 in The Lancet.
For the study, Lieven Lagae, M.D., from the University of Leuven in Belgium, and colleagues enrolled children and young adults with Dravet syndrome. One hundred nineteen patients were randomly assigned in a 1:1:1 ratio to receive either placebo, fenfluramine 0.2 mg/kg/day, or fenfluramine 0.7 mg/kg/day (40, 39, and 40 patients, respectively) for 14 weeks in addition to existing antiepileptic agents.
The researchers found that the median reduction in seizure frequency during treatment was 74.9 percent in the fenfluramine 0.7 mg/kg group (from median of 20.7 to 4.7 seizures per 28 days), 42.3 percent in the fenfluramine 0.2 mg/kg group (from median of 17.5 to 12.6 seizures per 28 days), and 19.2 percent in the placebo group (from median of 27.3 to 22.0 seizures per 28 days). The primary efficacy end point was met, with a 62.3 and 32.4 percent greater reduction in monthly convulsive seizure frequency for fenfluramine 0.7 and 0.2 mg/kg, respectively, versus placebo. During the trial, echocardiographic examinations revealed valve function within the normal physiological range in all patients and no signs of pulmonary arterial hypertension. “Further study is warranted to assess long-term efficacy and safety of fenfluramine for the treatment of Dravet syndrome, including its effect on cardiac valves,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Zogenix, which manufactured the study drug and funded the study.
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