Flexible dosing of adjunctive zonisamide in the treatment of adult partial-onset seizures: a non-comparative, open-label study (ZEUS)

Dupont, Sophie; Striano, Salvatore; Trinka, Eugen; Springub, Joachim; Giallonardo, Anna Teresa; Smith, Philip E. M.; Ellis, Simon J.; Yeates, Andrew; Baker, Gus A.

doi:10.1111/j.1600-0404.2009.01311.x

Cited by 22 publications

(26 citation statements)

References 17 publications

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“…Zonisamide in the European Union Study (ZEUS) was an open‐label study designed to determine the efficacy and tolerability of adjunctive zonisamide for treatment of partial seizures in a patient population more diverse and less refractory to treatment than in randomized controlled trials and in a setting more reflective of clinical practice . Involving 76 sites in nine European countries, the study enrolled adult patients, aged 18–75 years, diagnosed with partial seizures (simple or complex) with or without secondary generalization.…”

Section: Zonisamide Clinical Practice Studiesmentioning

confidence: 99%

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Zonisamide in clinical practice

Dupont

Stefan

2012

Acta Neurol Scand

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Zonisamide is currently licensed in Europe 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 Europe 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 Zonisamid im Alltag Der Epilepsiepatienten (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.

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Section: Zonisamide Clinical Practice Studiesmentioning

confidence: 99%

“…The study's primary end point was change in monthly seizure frequency from baseline to fixed‐dose period 2. Safety and tolerability were assessed by monitoring adverse events (AEs) and standard laboratory variables .…”

Section: Zonisamide Clinical Practice Studiesmentioning

confidence: 99%

Zonisamide in clinical practice

Dupont

Stefan

2012

Acta Neurol Scand

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“…After review of all clinical trials, 27 clinical trials met the inclusion criteria and were included for data abstraction in the second part of this meta‐analysis . Table summarizes the major characteristics of the included studies.…”

Section: Resultsmentioning

confidence: 99%

The adverse event profile of zonisamide: a meta-analysis

et al. 2013

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The first aim of our study was to analyze the adverse events statistically significantly associated with zonisamide, through a systematic review and meta-analysis of available randomized placebo-controlled trials (RCTs). The second aim was to compare these results with those obtained from an analysis of non-RCTs and observational studies. Randomized controlled trials were identified using Medline (PubMed), EMBASE (Ovid), and Cochrane CENTRAL, from 1990 to September 2012. RevMan version 5.1 and OpenMeta[Analyst] were used for analyses of RCT and non-RCTs, respectively. Six eligible studies with 1184 patients between 12 and 80 years of age were included in RCTs analysis. Fifteen adverse events were investigated. In this first part of the analysis, no adverse events were statistically significantly associated with zonisamide. In the non-RCT analysis, a high incidence of weight loss and headache was found. In RCTs, zonisamide was statistically significantly associated with an increased risk of adverse event-related study withdrawals [RR (99% CI) = 1.81 (1.07-3.08)]. Although our study revealed no statistically significantly associated adverse effects (AEs) with zonisamide, this is very likely a consequence of the small numbers in the RCTs available. The limited data available from the studies appear to reveal no major safety concerns related to zonisamide. However, the high incidence of weight loss and headache in the non-RCTs suggests that these AEs could be of clinical significance.

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“…As RCTs are conducted under controlled conditions, it can be difficult to translate the results to "real-world" clinical practice [21]. The following six studies show that zonisamide as monotherapy or adjunctive therapy for partial seizures, refractory partial seizures, and generalized seizures is effective when prescribed in the clinic, with safety and tolerability profiles similar to those of the RCTs [22][23][24][25][26][27].…”

Section: Zonisamide In Real-world Clinical Practicementioning

confidence: 99%

Zonisamide: Review of Recent Clinical Evidence for Treatment of Epilepsy

et al. 2015

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Zonisamide is an orally administered antiepileptic drug that was first approved for clinical use in Japan in 1989. Since then, it has been licensed in Korea for a broad spectrum of epilepsies in adults and children, and in the USA for adjunctive therapy of adults with partial seizures, and in Europe for monotherapy of adults with newly diagnosed partial seizures and adjunctive therapy of adults and adolescents and children aged ≥6 years with partial seizures with or without secondary generalization. Zonisamide is a benzisoxazole derivative with a unique chemical structure, predictable dose-dependent pharmacokinetics, and multiple complementary mechanisms of action. Treatment with zonisamide is well tolerated and is not known to be associated with clinically significant drug-drug interactions, including with oral contraceptives or other antiepileptic drugs. There have been >2 million patient-years of experience with zonisamide for treatment of epilepsy, and this drug has International League Against Epilepsy level A evidence for efficacy/effectiveness as initial monotherapy for adults with partial-onset seizures. This review presents the evidence for zonisamide across the spectrum of epilepsy, with emphasis on real-world clinical practice and special populations of patients (children, elderly patients, and women of childbearing age) who are likely to be treated in daily clinical practice.

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Flexible dosing of adjunctive zonisamide in the treatment of adult partial-onset seizures: a non-comparative, open-label study (ZEUS)

Cited by 22 publications

References 17 publications

Zonisamide in clinical practice

Zonisamide in clinical practice

The adverse event profile of zonisamide: a meta-analysis

Zonisamide: Review of Recent Clinical Evidence for Treatment of Epilepsy

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