Evaluation of safety and efficacy of zonisamide in adult patients with partial, generalized, and combined seizures: an open labeled, noncomparative, observational Indian study

Abstract

A prospective, multicentric, noncomparative open-label observational study was conducted to evaluate the safety and efficacy zonisamide in Indian adult patients for the treatment of partial, generalized, or combined seizures. A total of 655 adult patients with partial, generalized, or combined seizures from 30 centers across India were recruited after initial screening. Patients received 100 mg zonisamide as initiating dose as monotherapy/adjunctive therapy for 24 weeks, with titration of 100 mg every 2 weeks if required. Adverse events, responder rates, and seizure freedom were observed every 4 weeks. Efficacy and safety were also assessed using Clinicians Global Assessment of Response to Therapy and Patients Global Assessment of Tolerability to Therapy, respectively. Follow-up was conducted for a period of 24 weeks after treatment initiation. A total of 655 patients were enrolled and received the treatment and 563 completed the evaluation phase. A total of 20.92% of patients received zonisamide as monotherapy or alternative monotherapy and 59.85% patients received zonisamide as first adjunctive therapy. Compared with baseline, 41.22% of patients achieved seizure freedom and 78.6% as responder rate at the end of 24 week study. Most commonly reported adverse events were loss of appetite, weight loss, sedation, and dizziness, but discontinuation due to adverse events of drug was seen in 0.92% of patients. This open label real-world study suggests that zonisamide is an effective and well-tolerated antiepileptic drug in Indian adults for treatment of partial, generalized as well as combined seizures type. No new safety signals were observed.

Safety And Efficacy of Zonisamide in Refractory Epilepsy Patients: Clinical Experience from A Tertiary Center

“…Literatürde, ZNS kullanımıyla nöbet sıklığı azalan (bazal ile karşılaştırıldığında nöbet sıklığı ≥%50 azalmış hasta yüzdesi olarak tanımlanmıştır) hastaların oranı %40.9 ve %79.7 arasında, tam nöbetsizlik sağlanan hastala oranı ise %15 ve %43.6 arasındadır. [16][17][18][19] Dash ve ark., [20] hastaların %20.92'sinde ZNS'yi monoterapi veya alternatif monoterapi olarak, %59.85'inde de ekleme tedavi olarak kullandığı çalışmasında cevap oranını %78.6 olarak bildirmişler; hastalarının yaklaşık %41.22'sinin 24 haftalık ZNS tedavisinden sonra nöbetsiz olduğunu belirtmişlerdir. Lee ve ark.…”

“…[21] sif davranış, psikoz, uyku bozukluğu, döküntü ve diplopi literatürde bildirilmiş yan etkilerdir. [18,18,20] Hastalarımızın %10. Zonisamid, zayıf bir karbonik anhidraz inhibitörüdür.…”

Anticonvulsant Agents: Zonisamide

“…ZNS is a broad-spectrum AED and has been shown to be effective for the treatment of various generalized seizure types including absence seizures, tonicclonic seizures, and myoclonic seizures. Furthermore, efficacy in various pediatric epilepsy syndromes including juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), progressive myoclonus epilepsies, epilepsy with myoclonic-atonic seizures (Doose syndrome), Lennox-Gastaut syndrome, West syndrome, and Ohtahara syndrome could be documented (Asadi-Pooya 2018; Dash et al 2016;Ferlazzo et al 2017;Nickels et al 2018;Ohtahara 2006;Reimers and Ljung 2019;Serafini et al 2019;Velizarova et al 2014).…”

Development and Validation of a HPTLC Method to Determine Serum Zonisamide levels for Therapeutic Drug Monitoring in Clinical Settings

“…Zonisamide is a 1,2-benzisoxazole derivative, a new generation antiepileptic drug, which suppresses the epileptogenic focus and blocks the spread or propagation of seizure discharges [1,2] . It is used in the treatment of simple and complex partial seizures, refractory partial seizures, generalized tonic-clonic, generalized clonic and infantile spasms [1][2][3][4][5][6] . Prevention and management of seizures requires continuous maintenance of effective levels of the antiepileptic drugs in the body.…”

“…Prevention and management of seizures requires continuous maintenance of effective levels of the antiepileptic drugs in the body. Due to pharmacokinetic variability and interaction with other antiepileptic drugs, there can be issues of either over-dosing resulting in toxicity, side effects like drowsiness, ataxia or under-dosing with zonisamide [1,2] . Hence it becomes imperative to perform regular monitoring of zonisamide level in patients.…”