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Pooled efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures: Data from four double-blind placebo-controlled pivotal phase III clinical studies

Elger, Christian (author)
Koepp, Mathias (author)
Trinka, Eugen (author)
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Villanueva, Vicente (author)
Chaves, João (author)
Ben-Menachem, Elinor, 1945 (author)
Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience
Kowacs, Pedro A. (author)
Gil-Nagel, António (author)
Moreira, Joana (author)
Gama, Helena (author)
Rocha, José Francisco (author)
Soares-da-Silva, Patrício (author)
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 (creator_code:org_t)
2017-10-13
2017
English.
In: CNS Neuroscience and Therapeutics. - : Wiley. - 1755-5930 .- 1755-5949. ; 23, s. 961-972
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • © 2017 The Authors. CNS Neuroscience & Therapeutics Published by John Wiley & Sons Ltd. Purpose: Pooled evaluation of the key efficacy and safety profile of eslicarbazepine acetate (ESL) added-on to stable antiepileptic therapy in adults with focal-onset seizures. Methods: Data from 1703 patients enrolled in four phase III double-blind, randomized, placebo-controlled studies were pooled and analyzed. Following a 2week titration period, ESL was administered at 400mg, 800mg, and 1200mg once-daily doses for 12weeks (maintenance period). Pooled efficacy variable was standardized (/4weeks) seizure frequency (SSF) analyzed over the maintenance period as reduction in absolute and relative SSF and proportion of responders (≥50% reduction in SSF). Pooled safety was analyzed by means of adverse events and clinical laboratory assessments. Results: SSF was significantly reduced with ESL 800mg (P<0.0001) and 1200mg (P<0.0001) compared to placebo. Median relative reduction in SSF was 33.4% for ESL 800mg and 37.8% for 1200mg (placebo: 17.6%), and responder rate was 33.8% and 43.1% (placebo: 22.2%). ESL was more efficacious than placebo regardless of gender, geographical region, epilepsy duration, age at time of diagnosis, seizure type, and type of concomitant antiepileptic drugs (AED). Incidence of adverse events (AEs) and AEs leading to discontinuation was dose dependent. Most common AEs (>10% patients) were dizziness, somnolence, and nausea. The incidence of treatment-emergent AEs (dizziness, somnolence, ataxia, vomiting, and nausea) was lower in patients who began taking ESL 400mg (followed by 400mg increments to 800 or 1200mg) than in those who began taking ESL 600mg or 800mg. Conclusions: Once-daily ESL 800mg and 1200mg showed consistent results across all efficacy and safety endpoints, independent of study population characteristics and type of concomitant AEDs. Treatment initiated with ESL 400mg followed by 400mg increments to 800 or 1200mg provides optimal balance of efficacy and tolerability.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Neurosciences (hsv//eng)

Keyword

adjunctive therapy
adults
antiepileptic drugs
eslicarbazepine acetate
focal-onset seizures
refractory epilepsy

Publication and Content Type

ref (subject category)
art (subject category)

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