Zonegran® (zonisamide) continues to be well-tolerated and efficacious when used as long-term montherapy for the treatment of partial onset seizures in adults with newly diagnosed epilepsy, as demonstrated by a new publication in Epilepsia.1 Zonisamide is indicated as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.2
The extension study assesses zonisamide versus carbamazepine monotherapy in patients from 72 sites in 17 countries in Europe, Asia, Australia, and South Africa, with over three-quarters exposed to over 24 months of treatment. No other currently available anti-epileptic drug (AED) has been studied in a double blind monotherapy setting over such a long duration of treatment.1 Safety assessments included treatment-emergent adverse events (TEAEs) and clinical laboratory parameters. Efficacy assessments included retention rate and the proportion of patients who remain seizure free for ≥24 months. Up to 81.6% of patients received the lowest target dose levels (zonisamide 300 mg/day; carbamazepine 600 mg/day).1
"Monotherapy is the optimal treatment approach for newly diagnosed epilepsy and zonisamide's proven long-term efficacy in this setting is demonstrated by this study. This treatment, which is easy to titrate and offers the advantage of once daily dosing, may improve adherence to treatment for people with epilepsy," commented Professor Michel Baulac, manuscript lead author and head of the clinical department at the Hôpital de la Pitié-Salpêtrière, Paris, France.
The international, multicenter, randomised, double-blind extension of the Phase III non-inferiority trial (Study 310)3 shows that once-daily zonisamide monotherapy demonstrates favourable long-term safety and maintenance of efficacy in the treatment of partial onset seizures in adults with newly diagnosed epilepsy. Retention rates are similar between treatment groups at all time-points throughout the extension study. The proportion of patients who remain seizure free for ≥24 months is also similar for zonisamide (32.3%) and carbamazepine (35.2%). The incidence of treatment-related TEAEs is 26.3% for zonisamide compared with 19.6% for carbamazepine and the most frequently reported treatment-related TEAEs are decreased weight (5.1% vs. 0%), decreased appetite (3.6% vs. 0%), memory impairment (2.9% vs. 3.2%), and decreased hemoglobin (1.5% vs. 3.2%). Most TEAEs are of mild or moderate intensity.1
Zonisamide has multiple mechanisms of action and a chemical structure unrelated to any other AED.2 It is one of only four AEDs with level A evidence of efficacy as initial monotherapy for adults with partial onset seizures, as defined in the latest International League Against Epilepsy (ILAE) guidelines.5
The continued development of zonisamide underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of epilepsy and to address the unmet medical needs of people with epilepsy and their families. Eisai is proud to market currently more epilepsy products in EMEA than any other company.
About Zonegran (zonisamide)
Zonisamide is licensed in Europe as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. Zonisamide is also 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.1 It has a broad spectrum of anti-epileptic modes of action and has no appreciable effects on steady-state plasma concentrations of other AEDs, such as phenytoin, carbamazepine and valproate.1 Zonisamide is one of only four AEDs with level A efficacy/effectiveness evidence as initial monotherapy for adults with partial onset seizures.4 Worldwide there has been an estimated 1,274,963 patient-years of exposure to zonisamide (from 31.03.1989 to 31.03.2013).5
Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The recommended daily dose for monotherapy use is 100mg once daily. In the third and fourth weeks the dose may be increased to 200mg daily and then increased to 300mg daily after the next two weeks. The recommended initial daily dose for adjunctive use is 50mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg.1
For further information please visit: www.zonegran.eu