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Efficacy and safety...
Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies
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- Ben-Menachem, Elinor, 1945 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology
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Mameniskiene, R. (författare)
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Quarato, P. P. (författare)
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Klein, P. (författare)
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Gamage, J. (författare)
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Schiemann, J. (författare)
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Johnson, M. E. (författare)
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Whitesides, J. (författare)
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McDonough, B. (författare)
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Eckhardt, K. (författare)
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(creator_code:org_t)
- 2016
- 2016
- Engelska.
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Ingår i: Neurology. - 0028-3878. ; 87:3, s. 314-323
- Relaterad länk:
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Objective: To assess the efficacy, safety, and tolerability of adjunctive brivaracetam (BRV), a selective, high-affinity ligand for SV2A, for treatment of partial-onset (focal) seizures (POS) in adults. Methods: Data were pooled from patients (aged 16-80 years) with POS uncontrolled by 1 to 2 antiepileptic drugs receiving BRV 50, 100, or 200 mg/d or placebo, without titration, in 3 phase III studies of BRV (NCT00490035, NCT00464269, and NCT01261325, ClinicalTrials.gov, funded by UCB Pharma). The studies had an 8 -week baseline and a 12 -week treatment period. Patients receiving concomitant levetiracetam were excluded from the efficacy pool. Results: In the efficacy population (n = 1,160), reduction over placebo (95% confidence interval) in baseline-adjusted POS frequency/28 days was 19.5% (8.0%-29.6%) for 50 mg/d (p = 0.0015), 24.4% (16.8%-31.2%) for 100 mg/d (p < 0.00001), and 24.0% (15.3%-31.8%) for 200 mg/d (p < 0.00001). The >50% responder rate was 34.2% (50 mg/d, p 0.0015), 39.5% (100 mg/d, p < 0.00001), and 37.8% (200 mg/d, p = 0.00003) vs 20.3% for placebo (p < 0.01). Across the safety population groups (n = 1,262), 90.0% to 93.9% completed the studies. Treatment -emergent adverse events (TEAEs) were reported by 68.0% BRV overall (n 803) and 62.1% placebo (n = 459). Serious TEAEs were reported by 3.0% (BRV) and 2.8% (placebo); 3 patients receiving BRV and one patient receiving placebo died. TEAEs in >5% patients taking BRV (vs placebo) were somnolence (15.2% vs 8.5%), dizziness (11.2% vs 7.2%), headache (9.6% vs 10.2%), and fatigue (8.7% vs 3.7%). Conclusions: Adjunctive BRV was effective and generally well tolerated in adults with POS.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Nyckelord
- refractory partial seizures
- synaptic vesicle protein
- placebo-controlled trial
- double-blind
- adjunctive brivaracetam
- antiepileptic drugs
- epilepsy
- anticonvulsant
- sv2a
- levetiracetam
- Neurosciences & Neurology
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Ben-Menachem, El ...
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Mameniskiene, R.
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Quarato, P. P.
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Klein, P.
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Gamage, J.
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Schiemann, J.
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visa fler...
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Johnson, M. E.
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Whitesides, J.
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McDonough, B.
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Eckhardt, K.
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visa färre...
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- MEDICIN OCH HÄLSOVETENSKAP
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och Klinisk medicin
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Neurology
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Göteborgs universitet