title: 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: OBJECTIVE
  Evidence 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.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  Five 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.
  
  
  CONCLUSIONS
  These 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.
authors.affiliation: University Clinic for Neurology, Greifswald, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Runge
authors.affiliation: NeuroCenter Nymphenburg, Munich, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Arnold
authors.affiliation: Bethel Epilepsy Centre, Mara Hospital, Bielefeld, Germany.
authors.forename: Christian
authors.identifier: http://orcid.org/0000-0001-8666-1640
authors.initials: C
authors.lastname: Brandt
authors.affiliation: NeuroNetwork of Lusatia of the Technical University of Brandenburg, Cottbus-Senftenberg, Germany.
authors.forename: Fritjof
authors.initials: F
authors.lastname: Reinhardt
authors.affiliation: Private Practice, Oranienburg, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Kühn
authors.affiliation: UCB Pharma, Monheim am Rhein, Germany.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Isensee
authors.affiliation: UCB Pharma, Monheim am Rhein, Germany.
authors.forename: Francisco
authors.initials: F
authors.lastname: Ramirez
authors.affiliation: UCB Pharma, Brussels, Belgium.
authors.forename: Peter
authors.initials: P
authors.lastname: Dedeken
authors.affiliation: UCB Pharma, Monheim am Rhein, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lauterbach
authors.affiliation: UCB Pharma, Monheim am Rhein, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Noack-Rink
authors.affiliation: Saxonian Center for Epilepsy, Radeberg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Mayer
mesh_terms: D000081:Acetamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000078334:Lacosamide; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000081:Acetamides; D000927:Anticonvulsants; D000078334:Lacosamide
keywords: Adjunctive; Antiepileptic drug; Open-label; Real-world; Safety; Treatment