title: A randomized, double-blind comparison of antiepileptic drug treatment in the elderly with new-onset focal epilepsy.
abstract: OBJECTIVE
  To compare the effectiveness of controlled-released carbamazepine (CR-CBZ) to levetiracetam (LEV) and to lamotrigine (LTG) in elderly patients with newly diagnosed focal epilepsy.
  
  
  METHODS
  Randomized, double-blind, parallel-group trial conducted between January 2007 and August 2011, in 47 ambulatory or hospital sites in Germany, Austria, or Switzerland. Eligible participants were aged ≥ 60, had new-onset epilepsy, had no acute illness as the cause of their seizures, and had no contraindication to the drugs in the trial. Patients were randomized 1:1:1 to CR-CBZ, LTG, or LEV. Doses were up-titrated for 6 weeks and could be maintained or adjusted depending on seizure relapse or tolerability over an additional period of 52 weeks. Primary outcome was the retention to treatment at week 58; secondary measures related to seizure and adverse event frequency.
  
  
  RESULTS
  Of 361 randomized patients, 359 were included (CR-CBZ n = 121, LTG n = 117, LEV n = 122) in the modified intent-to-treat population (mean age [range] 71.4 [60-95] years). At week 58, the retention rate for LEV was significantly higher than for CR-CBZ (61.5% vs. 45.8%, p = 0.02), and similar to LTG (55.6%). Seizure freedom rates at weeks 30 and 58 were not different across the groups. Twice as many patients receiving CR-CBZ discontinued due to adverse events or death compared to those in the LEV group (32.2% vs. 17.2%; odds ratio 2.28, 95% confidence interval [CI] 1.25-4.19, p = 0.007), whereas discontinuation was intermediate for LTG (26.3%). Median daily doses of completers (n = 195) were CR-CBZ 380.0 mg/day (333.0-384.0), LTG 95 mg/day (94.0-97.0), and LEV 950 mg/day (940.0-985.0).
  
  
  CONCLUSIONS
  In the initial monotherapy of focal epilepsy in the elderly, 1-year retention to LEV was higher compared to CR-CBZ due to better tolerability. Retention of LTG was intermediate and close to LEV, but did not differ significantly from either comparators. NCT00438451, www.clinicaltrials.gov.
authors: Department of Neurology, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
authors: Konrad J
authors: KJ
authors: Werhahn
authors: Eugen
authors: E
authors: Trinka
authors: Judith
authors: J
authors: Dobesberger
authors: Iris
authors: I
authors: Unterberger
authors: Petra
authors: P
authors: Baum
authors: Maria
authors: M
authors: Deckert-Schmitz
authors: Tobias
authors: T
authors: Kniess
authors: Bettina
authors: B
authors: Schmitz
authors: Viviane
authors: V
authors: Bernedo
authors: Christian
authors: C
authors: Ruckes
authors: Anne
authors: A
authors: Ehrlich
authors: Günter
authors: G
authors: Krämer
mesh_terms: D000368:Aged; D000927:Anticonvulsants / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants
keywords: Antiepileptic drugs; Carbamazepine; Elderly; Levetiracetam; Monotherapy