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Safety and efficacy...
Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years
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Rosenfeld, W. (författare)
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Fountain, N. B. (författare)
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Kaubrys, G. (författare)
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- Ben-Menachem, Elinor, 1945 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap och rehabilitering,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience and Rehabilitation
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McShea, C. (författare)
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Isojarvi, J. (författare)
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Doty, P. (författare)
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(creator_code:org_t)
- Elsevier BV, 2014
- 2014
- Engelska.
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Ingår i: Epilepsy & Behavior. - : Elsevier BV. - 1525-5050. ; 41, s. 164-170
- 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
- Long-term (up to 8 years of exposure) safety and efficacy of the antiepileptic drug lacosamide was evaluated in this open-label extension trial (SP615 [ClinicalTrials.gov identifier: NCT00552305]). Patients were enrolled following participation in a double-blind trial or one of two open-label trials of adjunctive lacosamide for partial-onset seizures. Dosage adjustments of lacosamide (100-800 mg/day) and/or concomitant antiepileptic drugs were allowed to optimize tolerability and seizure reduction. Of the 370 enrolled patients, 77%, 51%, and 39% had >1, >3, or >5 years of lacosamide exposure, respectively. Median lacosamide modal dose was 400 mg/day. Common treatment-emergent adverse events (TEAEs) were dizziness (39.7%), headache (20.8%), nausea (17.3%), diplopia (17.0%), fatigue (16.5%), upper respiratory tract infection (16.5%), nasopharyngitis (16.2%), and contusion (15.4%). Dizziness (2.2%) was the only TEAE that led to discontinuation in N2% of patients. Ranges for median percent reductions in seizure frequency were 47-65%, and those for =50% responder rates were 49-63% for 1-, 3-, and 5-year completer cohorts. Exposure to lacosamide for up to 8 years was generally well tolerated, with a safety profile similar to previous double-blind trials, and efficacy was maintained.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Nyckelord
- Epilepsy
- Partial-onset seizures
- Antiepileptic drug
- Lacosamide
- RANDOMIZED CONTROLLED-TRIAL
- CLINICAL-TRIALS
- ESLICARBAZEPINE ACETATE
- PARTIAL EPILEPSY
- THERAPY
- ADULTS
- Behavioral Sciences
- Clinical Neurology
- Psychiatry
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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