UCB has announced data from two studies evaluating the efficacy and safety of Vimpat® (lacosamide) as early adjunctive treatment in adults with partial-onset seizures. The results are presented this week at the 11th European Congress on Epileptology (ECE) in Stockholm, Sweden.
"The open-label and real-life data presented at ECE show that early adjunctive therapy with Vimpat® can support patients with partial-onset seizures towards the goal of seizure freedom with manageable side effects." said Dr Plamen Tzvetanov from the Military Medical Academy, Pleven, Bulgaria.
Results from an open-label study showed that lacosamide as first adjunctive therapy was efficacious in achieving seizure freedom and was well-tolerated in patients with uncontrolled partial-onset seizures.1 Final results from the VITOBA™ study showed that in clinical practice lacosamide improved partial-onset seizure control and was generally well-tolerated when used as adjunctive treatment to one baseline antiepileptic drug.2
Abstract title: Efficacy and safety of lacosamide as first adjunctive treatment for uncontrolled partial-onset seizures: a multicenter open-label trial
This open-label trial enrolled 456 patients with partial-onset seizures. Patients received lacosamide as first adjunctive therapy to a first monotherapy within 2 years of diagnosis, or as later add-on to 1-3 concomitant antiepileptic drugs, after 2 or more previous antiepileptic drugs, at ≥5 years since diagnosis. The primary efficacy variable was the proportion of patients achieving seizure freedom for the first 12 weeks of the 24 week maintenance phase.1
Of the 333 patients who completed 12 weeks' treatment, 19.8% were seizure-free. Among 96 patients who received lacosamide as first add-on, 72 completed 12 weeks' treatment and 68 patients completed 24 weeks. 37.5% of patients who completed 12-weeks' treatment and 26.5% of patients who completed 24-weeks' treatment were seizure-free for the respective treatment periods.1
Among 360 patients who received lacosamide as later add-on, 261 completed 12 weeks' treatment and 249 completed 24 weeks. 14.9% of patients who completed 12-weeks' treatment and 11.6% of patients who completed 24-weeks' treatment were seizure-free for the respective treatment periods.1
The most common treatment-emergent adverse events were dizziness (31.3% as first add-on, 33.6% as later add-on), somnolence (6.3% and 15.0%), and headache (13.5% and 11.4%).1
Abstract title: Lacosamide added to a monotherapy in epilepsy patients with partial-onset seizures: final analysis of the VITOBA™ study
VITOBATM was a 6-month, prospective, non-interventional study of the efficacy, safety and tolerability of lacosamide when added to a single antiepileptic drug in 573 adult patients with partial-onset seizures. Outcome variables included seizure freedom and reduction in seizure frequency at last study visit (6 months) compared with 3-month retrospective baseline, as well as treatment-emergent adverse events.2
During the study, 499 patients were treated with lacosamide up to 400 mg/day. During the final three months of the study (n=494), 72.5% of patients showed a ≥50% reduction in seizure frequency of who 45.5% were seizure free. Seizure freedom and ≥50% responder rates in patients aged 65 years or older were higher than in patients younger than 65 years. Seizure freedom and ≥50% responder rates were also higher for patients who received lacosamide after the first monotherapy compared with patients who had received more than one previous AED.2
The most common treatment-emergent adverse events judged by physicians to be related to lacosamide were fatigue (10.3%) and dizziness (8.8%).2