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Epilepsy: pooled data from 17 clinical studies support safety of adjunctive Zonegran® (zonisamide) in children aged six and above

The safety profile of adjunctive Zonegran® () in paediatric patients with is confirmed by pooled data published in the European Journal of Paediatric Neurology(EJPN).[i] These newly published safety data from 17 studies support zonisamide’s proven clinical efficacy in children aged six years and above.[ii],[iii] Zonisamide is indicated in Europe as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.[iv]

“Selection of the most appropriate treatment approach for children with epilepsy is a challenge as epileptic seizures can often impact a child’s neurological development, as well as physical well-being. This makes well-tolerated treatment options that can be used in this age group, such as zonisamide, valuable for doctors and patients alike,” commented Professor Helen Cross, Great Ormond Street Hospital and Young Epilepsy, UK.

It is estimated that there are 900,000 children and adolescents who live with active epilepsy in Europe.[v] Although epilepsy is common among this age group, only two thirds will achieve seizure control and many will require additional AEDs to improve seizure control.[vi] Epilepsy in children often presents major challenges such as developmental and behavioural problems which can result in educational underachievement and a lack of self-esteem. These issues, which are frequently manifested in an attention deficit disorder, withdrawal, anxiety or depression, have a negative impact on both the child and their family.[vii]

The pooled analysis includes 507 people aged ?16 years involved in four randomised, double-blind studies and 13 uncontrolled, open-label trials.[i] A total of 398 children received zonisamide and 109 received placebo. Most treatment emergent adverse events (TEAEs) were of mild or moderate intensity, the majority of which are already described in the safety profile for zonisamide. The most frequent treatment-related TEAEs were decreased appetite (15.6%), somnolence (12.1%), fatigue (9.3%), dizziness (6.0%), decreased weight (5.8%), irritability (5.8%) and headache (5.3%). The incidence of TEAEs that led to discontinuation was low 10.3%.[i]

Zonisamide has multiple mechanisms of action and a chemical structure unrelated to any other AED.[ii] The use of adjunctive zonisamide in the treatment of partial seizures (with or without secondary generalisation) in children aged six years and above was approved by the European Commission in October 2013.