HealthDay News — Among patients with Lennox-Gastaut syndrome (LGS), the percentage reduction in the frequency of drop seizures is greater with fenfluramine vs placebo, according to a study published online May 2 in JAMA Neurology.
Kelly G. Knupp, MD, from the Children’s Hospital Colorado in Aurora, and colleagues examined the efficacy and safety of fenfluramine in patients with LGS (aged 2 to 35 years) from 65 sites in North America, Europe, and Australia. Participants were randomly assigned to receive a 0.7- or 0.2-mg/kg/d dose of fenfluramine or placebo (87, 89, and 87 patients, respectively).
The researchers found that the median percentage reduction in frequency of drop seizures was 26.5, 14.2, and 7.6 percentage points in the groups receiving the 0.7- and 0.2-mg/kg/d dose of fenfluramine and placebo, respectively. The trial met its primary efficacy end point, with a −19.9 percentage point estimated median difference in drop seizures from baseline for the 0.7-mg/kg/d dose of fenfluramine versus placebo. More patients in the group receiving the 0.7-mg/kg/d dose of fenfluramine achieved a 50% or greater response versus placebo (25 vs 10%). Generalized tonic-clonic (GTC) seizure was the subtype that seemed most responsive to fenfluramine, with reductions in frequency of 45.7 and 58.2% in the groups receiving the 0.7- and 0.2-mg/kg/d doses of fenfluramine and a 3.7% increase in the placebo group.
“Fenfluramine was also highly effective in reducing GTC seizures, suggesting that fenfluramine may be a particularly advantageous choice in patients with this seizure subtype,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Zogenix, which manufactures fenfluramine and funded the study.