Zonisamide in clinical practice

Dupont, Sophie; Stefan, Hermann

doi:10.1111/ane.12017

Cited by 13 publications

(7 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The efficacy and tolerability of ZNS as adjuvant therapy in adults with refractory partial epilepsy have been demonstrated in several randomized controlled trials. 18 However, the clinical application of these trial results is limited because of the short-term duration of study, strict control of concomitant AEDs, and recruitment of patients who satisfy strict inclusion criteria. 19 Several long-term observational studies have shown the clinical usefulness of ZNS in adult patients with partial epilepsy.…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Zonisamide in Patients with Epilepsy: A Post-Marketing Surveillance Study

et al. 2015

View full text Add to dashboard Cite

Background and Purpose:Zonisamide (ZNS) is one of new antiepileptic drug, which is known to inhibit seizure through multiple mechanisms of action. In Korea, ZNS was approved as an antiepileptic drug in 1992 and has been used for epilepsy patients with partial and generalized seizures. The objective of this study was to investigate the efficacy and tolerability of ZNS in patients with epilepsy and to identify the incidence of adverse events in real clinical setting.Methods:This study was carried out in patients who received ZNS for epilepsy. Patients who were observed for at least 12 weeks after treatment with ZNS were included as evaluable subjects. Information regarding the status and type of adverse events occurring during the course of treatment with ZNS was obtained regardless of causal relationship to ZNS and efficacy was assessed by the study physicians and patients at 12 weeks post dose of ZNS.Results:A total of 1,948 patients were included in the study, and ZNS efficacy was evaluated in 1,744 patients. ZNS was used as a monotherapy in 1,095 patients and as an adjunctive drug in 853 patients. Of the total patients, 1,345 (69.1%) patients had partial seizure, 563 patients had generalized seizure, and 40 patients were undetermined. Adverse events were reported in 65 patients (3.34%) including 1 case of Stevens-Johnson syndrome, but no incidence of serious unexpected adverse drug reactions were reported. 755 patients (43.29%) became seizure free with ZNS treatment, and additional 322 patients (18.41%) experienced marked improvement with ZNS treatment.Conclusions:Our study shows the safety and tolerability of ZNS treatment in patients with epilepsy in real clinical setting. In addition, ZNS was found to be an effective option as a monotherapy or in patients with generalized seizure.

show abstract

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Zonisamide in Patients with Epilepsy: A Post-Marketing Surveillance Study

et al. 2015

View full text Add to dashboard Cite

show abstract

“…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

View full text Add to dashboard Cite

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.

show abstract

“…Zonisamide is approved as monotherapy and adjunctive therapy for partial onset and generalized epilepsies in Japan and South Korea, and as monotherapy or adjunctive therapy for partial onset epilepsy in Europe 3,5. In the USA, the only indication approved by the US Food and Drug Administration (FDA) for zonisamide is adjunctive treatment of partial onset epilepsy.…”

Section: Introductionmentioning

confidence: 99%

Update on once-daily zonisamide monotherapy in partial seizures

Afra¹,

Adamolekun²

2014

NDT

View full text Add to dashboard Cite

Zonisamide is an antiepileptic drug that is structurally different from other antiepileptic agents. Its long half-life, once-daily dosing, lack of induction of hepatic enzymes, and broad spectrum of action makes it a suitable candidate for monotherapy. It has been approved as monotherapy for partial onset epilepsy in Japan and South Korea for more than a decade, and was recently approved as monotherapy in Europe. In the USA, it is only approved by the US Food and Drug Administration for adjunctive treatment of partial onset epilepsy. In this paper, we briefly review the literature on zonisamide monotherapy in partial onset epilepsy with regard to its efficacy, safety, tolerability, and long-term side effects, including a recent noninferiority trial in comparison with extended-release carbamazepine. While European regulatory agencies use noninferiority trials for approval of monotherapy, such a trial design does not meet the current regulatory requirements for approval as monotherapy in the USA.

show abstract

Zonisamide in clinical practice

Cited by 13 publications

References 12 publications

Safety and Efficacy of Zonisamide in Patients with Epilepsy: A Post-Marketing Surveillance Study

Safety and Efficacy of Zonisamide in Patients with Epilepsy: A Post-Marketing Surveillance Study

Zonisamide: Review of Recent Clinical Evidence for Treatment of Epilepsy

Update on once-daily zonisamide monotherapy in partial seizures

Contact Info

Product

Resources

About