The aim of a study was to evaluate the efficacy and safety of the new antiepileptic drug Brivaracetam ( Briviact ) as add-on treatment for drug-resistant partial epilepsy using meta-analytical techniques.
Randomized, placebo-controlled, single- or double-blind, add-on trials of Brivaracetam in adult patients with drug-resistant partial epilepsy were identified through a systematic literature search.
The following outcomes were assessed: 50% or greater reduction in seizure frequency, seizure freedom, incidence of treatment-emergent adverse events ( TEAEs ), and treatment withdrawal.
Six trials were included involving 2,399 participants according to the intent-to-treat, 1,715 for Brivaracetam, and 684 for placebo groups, respectively.
The pooled risk ratios ( RRs ) for the 50% responders and seizure freedom were 1.79 ( 95% CI,1.51-2.12 ) and 4.74 ( 95% CI, 2.00-11.25), respectively.
The subanalysis by Levetiracetam status did not show a statistically significant difference in the 50% responder rate when comparing Brivaracetam with placebo in patients with concomitant assumption of Levetiracetam.
The TEAEs significantly associated with Brivaracetam were irritability ( 2.99 [ 1.28-6.97 ] ), fatigue ( 2.19 [ 1.44-3.33 ] ), somnolence ( 1.97 [ 1.45-2.68 ] ), and dizziness ( 1.66 [ 1.19-2.31 ] ).
The overall RRs for treatment withdrawal due to TEAEs or any reason were 1.58 ( 95% CI, 1.04-2.40 ) and 1.27 ( 95% CI, 0.93-1.73 ), respectively.
In conclusion, in adults with drug-refractory focal epilepsy, add-on Brivaracetam was effective to reduce seizure frequency and fairly well-tolerated.
Further studies are needed to draw definitive conclusions about its efficacy in non-Levetiracetam-naive participants and evaluate its long-term safety profile. ( Xagena )
Lattanzi S et al, Neurology 2016;86:1344-1352