title: Levetiracetam versus carbamazepine in patients with late poststroke seizures: a multicenter prospective randomized open-label study (EpIC Project).
abstract: BACKGROUND
  Strokes are the leading cause of epileptic seizures in adults and account for 50% of seizures in those over the age of 65 years. The use of antiepileptic drugs to prevent recurrent poststroke seizures is recommended.
  
  
  METHODS
  One hundred and twenty-eight patients with poststroke seizures were randomly allocated to treatment with either levetiracetam (LEV) or sustained-release carbamazepine (CBZ) in a multicenter randomized open-label study. After a titration study phase (2 weeks), the optimal individual dose of trial medication was determined and treatment was continued for another 52 weeks. The primary endpoint was defined as the proportion of seizure-free patients; the secondary endpoints were: evaluation of time recurrence to the first seizure, EEG tracings, cognitive functions and side effects.
  
  
  RESULTS
  Of 128 patients, 22 discontinued the trial prematurely; thus a total of 106 patients (52 treated with LEV and 54 treated with CBZ) were included in the analysis. The results of the study were as follows: no significant difference in number of seizure-free patients between LEV and CBZ (p = 0.08); time to the first recurrence tended to be longer among patients on LEV; there was no correlation between the therapeutic effect and the EEG findings in either treatment group; LEV caused significantly fewer (p = 0.02) side effects than CBZ; attention deficit, frontal executive functions and functional scales (Activities of Daily Living and Instrumental Activities of Daily Living indices) were significantly worse in the CBZ group.
  
  
  CONCLUSIONS
  This trial suggests that LEV may be a valid alternative to CBZ in poststroke seizures, particularly in terms of efficacy and safety. In addition, our results show that LEV has significant advantages over CBZ on cognitive functions. This trial also indicates that LEV in monotherapy is a safe and effective therapeutic option in elderly patients who have suffered epileptic seizures following a stroke.
authors.affiliation: Operative Unit of Neurology, Jazzolino Hospital, IT–89900 Vibo Valentia, Italy. neurologiavv@live.it
authors.forename: D
authors.initials: D
authors.lastname: Consoli
authors.forename: D
authors.initials: D
authors.lastname: Bosco
authors.forename: P
authors.initials: P
authors.lastname: Postorino
authors.forename: F
authors.initials: F
authors.lastname: Galati
authors.forename: M
authors.initials: M
authors.lastname: Plastino
authors.forename: G F
authors.initials: GF
authors.lastname: Perticoni
authors.forename: G A
authors.initials: GA
authors.lastname: Ottonello
authors.forename: B
authors.initials: B
authors.lastname: Passarella
authors.forename: S
authors.initials: S
authors.lastname: Ricci
authors.forename: G
authors.initials: G
authors.lastname: Neri
authors.forename: D
authors.initials: D
authors.lastname: Toni
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002220:Carbamazepine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D010889:Piracetam / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D012640:Seizures / Q000188:drug therapy* / Q000209:etiology; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D002220:Carbamazepine; D000077287:Levetiracetam; D010889:Piracetam