title: Safety and tolerability of zonisamide in elderly patients with epilepsy.
abstract: OBJECTIVE
  To assess the safety/tolerability of zonisamide in elderly patients.
  
  
  METHODS
  A pooled analysis of clinical study data from elderly (≥65 years) patients receiving add-on/monotherapy zonisamide for partial seizures was compared with pooled adult (18-65 years) study data. Assessments included treatment-emergent adverse events (TEAEs), clinical laboratory parameters and weight change.
  
  
  RESULTS
  Data were analyzed from 95 elderly and 1389 adult patients. Incidence of total TEAEs was similar (elderly, 78/95 [82%] vs adult, 1165/1389 [84%]); but lower in elderly versus adult patients for treatment-related TEAEs (53/95 [56%] vs 1010/1389 [73%]), severe TEAEs (11/95 [12%] vs 289/1389 [21%]), serious TEAEs (12/95 [13%] vs 230/1389 [17%]) and TEAEs leading to withdrawal (17/95 [18%] vs 312/1389 [23%]). Most TEAEs were of mild-to-moderate intensity. TEAEs reported more frequently by elderly versus adult patients included fatigue (11/95 [12%] vs 135/1389 [10%]), nasopharyngitis (8/95 [8%] vs 100/1389 [7%]), constipation (7/95 [7%] vs 67/1389 [5%]) and pruritus (6/95 [6%] vs 29/1389 [2%]). The only serious TEAEs reported by ≥2% of elderly patients were 'convulsions' (4/95 [4%] vs 49/1389 [4%]). Three elderly patients died; one death was considered treatment-related. TEAEs leading to discontinuation of ≥2% of elderly patients were dizziness (4/95 [4%]), headache (2/95 [2%]), somnolence (2/95 [2%]) and confusional state (2/95 [2%]). For elderly patients, there were minimal changes in clinical laboratory parameters, no reports of respiratory alkalosis or metabolic acidosis and no significant weight changes.
  
  
  CONCLUSIONS
  Zonisamide demonstrated a favourable safety/tolerability profile in elderly patients. No new or unexpected safety findings were identified.
authors.affiliation: Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.
authors.forename: E
authors.initials: E
authors.lastname: Trinka
authors.forename: L
authors.initials: L
authors.lastname: Giorgi
authors.forename: A
authors.initials: A
authors.lastname: Patten
authors.forename: J
authors.initials: J
authors.lastname: Segieth
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000627:therapeutic use*; D016206:Databases, Bibliographic; D004305:Dose-Response Relationship, Drug; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use*; D008297:Male; D016896:Treatment Outcome; D000078305:Zonisamide
chemical_list: D000927:Anticonvulsants; D007555:Isoxazoles; D000078305:Zonisamide
keywords: elderly; epilepsy; pooled analysis; safety; tolerability; zonisamide