Efficacy and tolerability of fenfluramine with concomitant potassium bromide in patients with Dravet syndrome.

ABSTRACT:

Objective

To assess the efficacy and tolerability of fenfluramine (FFA) with concomitant potassium bromide (BR) in patients with Dravet syndrome (DS).

Methods

This multicenter retrospective study, conducted within the German compassionate use program, analyzed BR doses and serum levels before and after FFA initiation, adverse events (AEs), seizure reduction, and symptoms changes using the Clinical Global Impression of Change (CGIC) scale. Timepoints were defined as T0 (baseline), T1 (FFA initiation), T2 and T3 (first and second BR level measurement after FFA initiation).

Results

Twenty-two patients (median age 8.9 years, range 2.2-26.7) treated with BR were included. Median duration of BR-FFA combination therapy was 7 months (range 0-28). BR doses were reduced at leas

SUBMITTER: Pringsheim M 

PROVIDER: S-EPMC12514371 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature