A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial‐onset seizures in daily clinical practice: The VITOBA study

Abstract

SummaryObjectiveEvidence for the efficacy and safety of adjunctive lacosamide in the treatment of partial‐onset seizures (POS) was gained during placebo‐controlled clinical trials in patients with treatment‐resistant seizures who were taking one to three concomitant antiepileptic drugs (AEDs). The VITOBA study (NCT01098162) evaluated the effectiveness and tolerability of adjunctive lacosamide added to one baseline AED in real‐world clinical practice.MethodsWe conducted a 6‐month observational study at 112 sites across Germany. Adult patients (≥16 years) with POS received lacosamide adjunctive to only one baseline AED. Seizure frequency reduction at the end of the observation period was compared with a 3‐month retrospective baseline period.ResultsFive hundred seventy‐one patients received lacosamide at least once (Safety Set [SS]); 520 provided evaluable seizure records (Full Analysis Set [FAS]); and 499 took in‐label dosages of lacosamide (up to 400 mg) and were evaluated for effectiveness (modified FAS). Median baseline seizure frequency was 2.0 per 28 days: 47.1% of patients (235/499, mFAS) took a concomitant sodium channel–blocking (SCB) AED; 38.1% (190/499) had only one lifetime AED; and 18.4% (92/499) were aged ≥65 years (mFAS). At the final visit, 72.5% (358/494) of patients showed a ≥50% reduction in seizure frequency from baseline, 63.8% (315/494) showed a ≥75% reduction, and 45.5% (225/494) were seizure‐free. Seizure freedom rates were higher in patients aged ≥65 years (56.7%) compared with patients aged <65 years (43.1%), in patients with ≤5 years epilepsy duration (52.5%) versus >5 years duration (41.0%), and when added to first monotherapy (60.5%) rather than as a later therapy option. Treatment‐emergent adverse events (TEAEs) were reported by 48.5% (277/571) of patients (SS), with a profile similar to that observed in pivotal trials; 466 of patients (81.6%, SS) continued lacosamide therapy after the trial.SignificanceThese results suggest that lacosamide use, added to one concomitant AED, was effective at improving seizure control and was well tolerated in patients treated in routine clinical practice.

Eslicarbazepine acetate as monotherapy in clinical practice: Outcomes from Euro-Esli

“…1,26 For example, in the phase III monotherapy trial conducted in patients with newly diagnosed epilepsy, the most frequently reported ESL-related AEs (≥5% of patients) were dizziness, headache, somnolence, and fatigue, and the AEs that most frequently led to ESL discontinuation (≥1% of patients) were fatigue, nausea, dizziness, somnolence, and rash. [31][32][33] In a retrospective, non-interventional chart review of 439 patients with focal seizures, aged ≥16 years, who were treated with lacosamide monotherapy according to standard clinical practice in Italy, Spain, and the Netherlands, 6-month seizure freedom rates were 66.3% in patients treated with lacosamide as initial monotherapy and 63.0% 26 Therefore, it is perhaps unsurprising that the incidence of AEs leading to discontinuation was higher when ESL was used as adjunctive therapy versus monotherapy, since sodium channel blocking is the most common mechanism of have reported outcomes for the use of monotherapy with another member of the dibenzazepine family of AEDs, oxcarbazepine, in the clinical practice setting.…”

Epileptic seizure, as the first symptom of hypoparathyroidism in children, does not require antiepileptic drugs

“…Runge [11] evaluated the effectiveness of lacosamide for almost 6 months since its addition to therapy. Hussain [12] evaluated the effectiveness of cannabidiol (CBD) as an add-on therapy for patients with infantile spasms (IS) or Lennox–Gastaut (G) syndrome at ∼6.8 months after medication started.…”

New developments in the management of partial-onset epilepsy: role of brivaracetam

“…Furthermore, LCM may work better as first add-on than later adjunctive treatment for uncontrolled POS 39,40. Several recent experiences suggest that LCM monotherapy, either as first-line or after conversion, may be a valuable option, even in the long term, for patients with focal epilepsy 41–43.…”