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Zonisamide in clinical practice
Author(s) -
Dupont S.,
Stefan H.
Publication year - 2012
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/ane.12017
Subject(s) - zonisamide , tolerability , medicine , adjunctive treatment , clinical trial , randomized controlled trial , clinical practice , epilepsy , placebo , dosing , adverse effect , psychiatry , physical therapy , alternative medicine , topiramate , pathology
Zonisamide is currently licensed in E urope and the USA for the adjunctive treatment of partial seizures (with or without secondary generalization) in adults, based on the results of four pivotal, randomized, double‐blind, placebo‐controlled trials. It is also licensed in E urope as monotherapy for adults with newly diagnosed partial epilepsy, based on the results of a randomized, double‐blind, non‐inferiority trial. Because clinical trials are conducted under tightly controlled conditions, using rigid dosing schedules and employing strict exclusion/exclusion criteria, there is a need for ‘real‐world’ evidence of an antiepileptic drug's effectiveness and tolerability in clinical practice, where patients are much more diverse in terms of clinical characteristics and treatment is tailored to the individual's specific needs. Several studies have demonstrated that adjunctive treatment with zonisamide is effective when administered under everyday clinical practice conditions, with a favourable safety/tolerability profile similar to that observed in clinical trials. In the Z onisamid im A lltag D er E pilepsiepatienten ( ZADE ) study, almost 80% of patients showed a reduction in seizure frequency of ≥50% over a median follow‐up of 18 weeks, and over one‐third of patients became seizure free. Data from these clinical practice studies also indicate that zonisamide is effective and generally well tolerated when administered as a first‐line adjunctive treatment and is associated with high retention rates and improvements in quality of life. Evidence from these clinical practice studies therefore complements data from zonisamide's clinical trial programme, providing pragmatic information on the likely benefits and risks of treatment under real‐life conditions.