Safety and tolerability of zonisamide in elderly patients with epilepsy.
Acta Neurol Scand
; 128(6): 422-8, 2013 Dec.
Article
em En
| MEDLINE
| ID: mdl-23773051
ABSTRACT
OBJECTIVES:
To assess the safety/tolerability of zonisamide in elderly patients. MATERIALS &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.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Epilepsia
/
Isoxazóis
/
Anticonvulsivantes
Tipo de estudo:
Prognostic_studies
Limite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article