title: The LaLiMo Trial: lamotrigine compared with levetiracetam in the initial 26 weeks of monotherapy for focal and generalised epilepsy--an open-label, prospective, randomised controlled multicenter study.
abstract: BACKGROUND
  Of the newer antiepileptic drugs, lamotrigine (LTG) and levetiracetam (LEV) are popular first choice drugs for epilepsy. The authors compared these drugs with regard to their efficacy and tolerability in the initial monotherapy for epilepsy.
  
  
  METHODS
  A randomised, open-label, controlled, parallel group, multicenter trial was conducted to test the superiority of the LEV arm over the LTG arm. The primary endpoint was the rate of seizure-free patients in the first 6 weeks (two-sided Fisher's exact test, α=0.05, intent-to-treat set). Furthermore, efficacy, tolerability and quality of life were evaluated. The authors included 409 patients aged ≥12 years with newly diagnosed focal or generalised epilepsy defined by either two or more unprovoked seizures or one first seizure with high risk for recurrence. Patients were titrated to 2000 mg/day of LEV or 200 mg/day of LTG reached on day 22 or 71, respectively. Two dose adjustments by 500/50 mg were allowed.
  
  
  RESULTS
  The proportions of seizure-free patients were 67.5% (LEV) versus 64.0% (LTG) 6 weeks after randomisation (p=0.47), and 45.2% (LEV) versus 47.8% (LTG) during the whole treatment period of 26 weeks. The HR (LEV vs. LTG) for seizure-free time was 0.86 (95% CI, 0.61 to 1.22). Adverse events occurred in 74.5% (LEV) versus 70.6% (LTG) of the patients (p=0.38). Adverse events associated with study discontinuation occurred in 17/204 (LEV) versus 8/201 (LTG) patients (p=0.07).
  
  
  CONCLUSIONS
  There were no significant differences with regard to efficacy and tolerability of LEV and LTG in newly diagnosed focal and generalised epilepsy despite more rapid titration in the LEV arm.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT00242606.
authors.affiliation: Epilepsy Center Hessen, Department of Neurology, University Hospitals Giessen & Marburg, Baldingerstrasse, 35043 Marburg, Germany. rosenow@med.uni-marburg.de
authors.forename: Felix
authors.initials: F
authors.lastname: Rosenow
authors.forename: Carmen
authors.initials: C
authors.lastname: Schade-Brittinger
authors.forename: Nicole
authors.initials: N
authors.lastname: Burchardi
authors.forename: Sebastian
authors.initials: S
authors.lastname: Bauer
authors.forename: Karl Martin
authors.initials: KM
authors.lastname: Klein
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Weber
authors.forename: Holger
authors.initials: H
authors.lastname: Lerche
authors.forename: Stefan
authors.initials: S
authors.lastname: Evers
authors.forename: Stjepana
authors.initials: S
authors.lastname: Kovac
authors.forename: Susanne
authors.initials: S
authors.lastname: Hallmeyer-Elgner
authors.forename: Götz
authors.initials: G
authors.lastname: Winkler
authors.forename: Joachim
authors.initials: J
authors.lastname: Springub
authors.forename: Mathias
authors.initials: M
authors.lastname: Niedhammer
authors.forename: Erhard
authors.initials: E
authors.lastname: Roth
authors.forename: Ilonka
authors.initials: I
authors.lastname: Eisensehr
authors.forename: Jörg
authors.initials: J
authors.lastname: Berrouschot
authors.forename: Stephan
authors.initials: S
authors.lastname: Arnold
authors.forename: Michael
authors.initials: M
authors.lastname: Schröder
authors.forename: Anja
authors.initials: A
authors.lastname: Beige
authors.forename: Wolfgang H
authors.initials: WH
authors.lastname: Oertel
authors.forename: Adam
authors.initials: A
authors.lastname: Strzelczyk
authors.forename: Anja
authors.initials: A
authors.lastname: Haag
authors.forename: Philipp S
authors.initials: PS
authors.lastname: Reif
authors.forename: Hajo M
authors.initials: HM
authors.lastname: Hamer
mesh_terms: D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D042241:Early Diagnosis; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077213:Lamotrigine; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D010889:Piracetam / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011788:Quality of Life; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000927:Anticonvulsants; D014227:Triazines; D000077287:Levetiracetam; D000077213:Lamotrigine; D010889:Piracetam