Adjunctive brivaracetam safe, effective for long-term treatment of patients with epilepsy
Long-term use of brivaracetam as an adjunctive treatment is well tolerated and effective in patients with focal seizures or primary generalized seizures (PGS), as shown in a study.
The study included patients aged ≥16 years who had completed double‐blind, placebo‐controlled adjunctive brivaracetam trials. Safety analysis involved 652 patients with focal seizures and 15 with PGS, while efficacy analysis comprised 648 and 15 patients, respectively.
Overall, 49.2 percent of patients had ≥48 months of exposure to the drug. Treatment‐emergent adverse events (TEAEs) occurred in 608 patients (91.2 percent), including 595 (91.3 percent) with focal seizures. Brivaracetam discontinuation was reported in 14.8 percent of patients due to TEAEs, in 56.7 percent due to drug‐related TEAEs, and in 22.8 percent due to serious TEAEs. Common reported TEAEs in the focal seizures group were headache (25.3 percent) and dizziness (21.9 percent).
Mean changes from baseline in anxiety and depression (measured using the Hospital Anxiety and Depression Scale) over the 2‐year evaluation period were −0.7 and −0.2, respectively.
In terms of efficacy, median reduction from baseline in focal seizure frequency per 28 days was 57.3 percent. The 50-percent responder rate was 55.6 percent, with 6‐ and 12‐month seizure freedom rates of 30.3 percent and 20.3 percent, respectively.
Efficacy outcomes improved with increasing duration of exposure to brivaracetam, with changes remaining stable through 9 years. Quality of life also improved. Mean improvement in Patient‐Weighted Quality of Life in Epilepsy Inventory total score (efficacy set) from baseline were 5.7 at month 12 and 6.5 at month 24.
The present data support the long‐term use of adjunctive brivaracetam to treat patients with focal seizures, researchers said.