Randomized controlled trial of zonisamide for the treatment of refractory partial-onset seizures

Faught, Edward; Ayala, Ricardo; Montouris, G. G.; Leppik, Ilo E.

doi:10.1212/wnl.57.10.1774

Cited by 206 publications

(123 citation statements)

References 13 publications

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“…Two class I placebo-controlled studies [Faught et al 2001;Schmidt et al 1993] which compared zonisamide (at doses of 20 mg/kg in the Schmidt and colleagues study, and doses of 100, 200, and 400 mg/day in the study by Faught and colleagues) with placebo were reviewed. The discontinuation rates were 10% for both placebo and zonisamide-treated patients.…”

Section: Zonisamidementioning

confidence: 99%

New generation antiepileptic drugs: what do they offer in terms of improved tolerability and safety?

French

Gazzola

2011

Therapeutic Advances in Drug Safety

114

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Over the last two decades a total of 11 antiepileptic drugs (AEDs) have been introduced to the US market. Randomized, placebo-controlled trials have yielded information about each drug's efficacy, tolerability, and safety profile; however, few studies have compared the newer generation AEDs directly with the older generation. Comparative studies are not always straightforward in their interpretation, as many characteristics of drugs, both favorable and unfavorable, may not be highlighted by such studies. In general, findings from the literature suggest that the newer generation AEDs (including vigabatrin, felbamate, gabapentin, lamotrigine, tiagabine, topiramate, levetiracetam, oxcarbazepine, zonisamide, pregabalin, rufinamide, and lacosamide) enjoy both improved tolerability and safety compared with older agents such as phenobarbital, phenytoin, carbamazepine, and valproate. This is partially supported by some of the findings of the QSS and the TTA Committee of the American Academy of Neurology (AAN), whose review of four AEDs (gabapentin, lamotrigine, topiramate, and tiagabine) is discussed. Briefly, when compared with carbamazepine, lamotrigine was better tolerated; topiramate adverse events (AEs) were fairly comparable to carbamazepine and valproate; and tiagabine compared with placebo was associated with a higher discontinuation rate due to AEs. The findings of the SANAD trial are also presented; when administered to patients with partial epilepsy, carbamazepine was most likely to fail due to AEs, and lamotrigine and gabapentin were least likely to fail due to AEs. When administered to patients with idiopathic generalized epilepsy, topiramate was most frequently associated with AE-related discontinuation, followed by valproate; and while valproate was the most efficacious drug in this arm of the study, lamotrigine was more tolerable. What makes the SANAD study valuable and somewhat unique is its head-to-head comparison of one drug with another. Such comparative trials are overall lacking for new AEDs, although some conclusions can be drawn from the available data. In the end, however, AED selection must be based on individual patient and drug characteristics.

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Section: Zonisamidementioning

confidence: 99%

New generation antiepileptic drugs: what do they offer in terms of improved tolerability and safety?

French

Gazzola

2011

Therapeutic Advances in Drug Safety

114

View full text Add to dashboard Cite

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“…Two studies with class I evidence have been published to date: one study compared the efficacy of a 20 mg/kg dose (or a maximal blood level of 40 mg/L) to placebo, 31 and the second study compared efficacies of three different doses of zonisamide (100 mg/day, 200 mg/day, and 400 mg/day) to placebo. 32 In the first study, zonisamide's 50% responder rate was 30% and the placebo's was 9.4%. In the second study, zonisamide's 50% responder rate at both 100 mg/day and 200 mg/day was 25% (versus 9.8 and 11.3% for placebo) and at 400 mg/day the responder rate was 43% (versus 9% for placebo).…”

mentioning

confidence: 99%

Efficacy and tolerability of the new antiepileptic drugs II: Treatment of refractory epilepsy [RETIRED]

et al. 2004

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Abstract-Objective:To assess the evidence demonstrating efficacy, tolerability, and safety of seven new antiepileptic drugs (AEDs) (gabapentin, lamotrigine, topiramate, tiagabine, oxcarbazepine, levetiracetam, and zonisamide) in the treatment of children and adults with refractory partial and generalized epilepsies. Methods: A 23-member committee including general neurologists, pediatric neurologists, epileptologists, and doctors in pharmacy evaluated the available evidence based on a structured literature review including MEDLINE, Current Contents, and Cochrane library for relevant articles from 1987 until March 2003. Results: All of the new AEDs were found to be appropriate for adjunctive treatment of refractory partial seizures in adults. Gabapentin can be effective for the treatment of mixed seizure disorders, and gabapentin, lamotrigine, oxcarbazepine, and topiramate for the treatment of refractory partial seizures in children. Limited evidence suggests that lamotrigine and topiramate are also effective for adjunctive treatment of idiopathic generalized epilepsy in adults and children, as well as treatment of the Lennox Gastaut syndrome. Conclusions: The choice of AED depends upon seizure and/or syndrome type, patient age, concomitant medications, AED tolerability, safety, and efficacy. The results of this evidence-based assessment provide guidelines for the prescription of AEDs for patients with refractory epilepsy and identify those seizure types and syndromes where more evidence is necessary.

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“…Magas dózisú zonisamiddal kezelt betegek esetében a depresszió előfordulását mintegy 7%-nak találták, de amennyiben monoterápiát alkalmaznak és fokozatosan állítják be a dózist, jelentősen csökkenthető a hangulati zavarok előfordulásának a valószínűsége [17,18]. Más antiepileptikumok, így a tiagabin, a levetiracetam és a felbamat esetében a depresszogén hatás közepes mértékű, és a betegek nagyjából 4%-ánál alakul ki depresszió a kezelés során.…”

Section: Epilepszia Kezelésére Alkalmazott Gyógyszerekunclassified

Anxiogenic and depressogenic side-effects of non-psychiatric drugs

et al. 2013

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Annak ellenére, hogy számos szomatikus betegség kezelésére alkalmazott -például daganatellenes, antimikrobás, immunmoduláns, neurológiai, illetve hormonháztartásra ható -gyógyszer hathat negatív irányban a hangulatra, ezt egészen a rimonabant 2008-ban emiatt történt visszavonásáig nem kezelték jelentőségének megfelelően. A szerzők a teljes gyógyszerpalettát áttekintve tárgyalják a szorongást és a depressziót, mint gyógyszer-mellékhatásokat. A gyógyszerválasztásnál minden esetben fi gyelembe kell venni, ha a betegeknél magas a depresszió kialakulásának a kockázata, például, ha már korábban előfordult vagy jelenleg is fennáll a depressziós epizód vagy betegség, ha a családi anamnézisben előfordul depresszió, illetve ha a betegnél olyan neurotikus személyiségvonások állnak fenn, amelyek következtében sérülékenyebb a depressziót kiváltó hatásokkal szemben. A veszélyt jelentő gyógyszerek felírása előtt emellett célszerű fi gyelembe venni az alkalmazni kívánt szer hatékonyságát, a rendelkezésre álló alternatív gyógyszeres és nem gyógyszeres terápiás lehetőségeket, és minden esetben biztosítani kell a beteg monitorozását a kezelés során az esetleges depressziós vagy szorongásos tünetek mihamarabbi észlelése érdekében. Orv. Hetil., 2013, 154, 1327-1336.Kulcsszavak: depresszió, pszichiátriai mellékhatások, rimonabant, gyógyszermellékhatás, személyre szabott orvoslás Anxiogenic and depressogenic side-effects of non-psychiatric drugsAlthough medications such as anticancer, antimicrobial, immunomodulatory, neurological or hormonal therapies may have a negative impact on mood, adequate attention was not paid until the withdrawal of rimonabant in 2008. In the present study the authors review full spectrum of currently available medications discussing anxiety and depression as possible adverse effects of treatment. A relatively high risk of depression should always be considered when pharmacotherapy applied, especially if current depressive episodes, positive family history, or neurotic personality traits increasing susceptibility to depressogenic effects. Prior to start of medical treatment, the potential effectiveness of the given drug should be precisely evaluated, and alternative medical and non-medical treatment options should also be carefully considered. In addition, monitoring patients during treatment for signs of depressive or anxious symptoms is necessary. Orv. Hetil., 2013, 154, 1327-1336

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Randomized controlled trial of zonisamide for the treatment of refractory partial-onset seizures

Abstract: Zonisamide is effective and well tolerated as an adjunctive agent for refractory partial-onset seizures. The minimal effective dosage was 100 mg/d, but 400 mg/d was the most effective dosage.

Cited by 206 publications

References 13 publications

New generation antiepileptic drugs: what do they offer in terms of improved tolerability and safety?

New generation antiepileptic drugs: what do they offer in terms of improved tolerability and safety?

Efficacy and tolerability of the new antiepileptic drugs II: Treatment of refractory epilepsy [RETIRED]

Anxiogenic and depressogenic side-effects of non-psychiatric drugs

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