Long-term adjunctive lacosamide treatment in patients with partial-onset seizures.
Details
Serval ID
serval:BIB_2A4FFCB7C5F3
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Long-term adjunctive lacosamide treatment in patients with partial-onset seizures.
Journal
Acta neurologica Scandinavica
Working group(s)
SP774 study investigators
Contributor(s)
Berkovic S., Kiley M., O'Brien T., Reutens D.C., Seneviratne W.U., Robinson M.K., Schapel G.J., Somerville E.R., Babic T., Poljakovic Z., Demarin V., Hajnsek S., Bar M., Buresova J., Hojdikova H., Kralove H., Marusic P., Nespor E., Rektor I., Vacovska H., Zarubova J., Kälviäinen R.K., Keränen T., Korpelainen J.T., Lamusuo SLK, Nylund T., Crespel A., Derambure P., Ryvlin P., Semah F., Tibergé M., Valton L., Arnold S., Siebold C., Holtkamp M., Schmitz B., Lerche H., Meencke H.J., Nitsche M., Tergau F., Stefan H., Balogh A., Halász P., Horvath A., Komoly S., Kondakor I., Sólyom A., Vécsei L., Endziniene M., Liesiene V., Mameniskiene R., Skaringa A.A., Czlonkowska A., Fryze W., Kochanowicz J., Mazurkiewicz-Beldzinska M., Motyl R., Fedin A., Guekht A., Guzeva V., Karlov V., Kotov S., Petrukhin A., Skoromets A., Gil-Nagel A., Llerda JAM, Moro M.M., Molins A., Sanchez J.C., Serratosa M., Lindström P., Söderfeldt B., Brodie J., Cockerell O.C., Cooper P.N., Roberts R.C., Sawhney IMS, Smith E.M.
ISSN
1600-0404 (Electronic)
ISSN-L
0001-6314
Publication state
Published
Issued date
02/2016
Peer-reviewed
Oui
Volume
133
Number
2
Pages
136-144
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Publication Status: ppublish
Abstract
To evaluate long-term (up to 5.5 years) safety, seizure reduction, and maintenance of efficacy of the antiepileptic drug (AED) lacosamide as adjunctive treatment in an open-label extension trial (SP774; ClinicalTrials.gov: NCT00515619).
Three hundred and seventy-six adults with partial-onset seizures taking 1-3 AEDs enrolled following completion of a double-blind trial of adjunctive lacosamide. During open-label treatment, dosage of lacosamide (100-800 mg/day) and/or concomitant AEDs could be adjusted to optimize tolerability and seizure control.
Kaplan-Meier estimates of patient retention were 74.5% at 12 months, 52.9% at 36 months, and 40.6% at 60 months; median open-label treatment duration was 1183 days (~3.2 years). The most frequently reported treatment-emergent adverse events were dizziness (24.2%), headache (14.4%), diplopia (13.8%), and nasopharyngitis (13.8%); 9.0% of patients discontinued due to adverse events, most commonly dizziness (1.3%). Median percent reduction in 28-day seizure frequency from baseline of the double-blind trial was 49.9% overall, 55.4% for 1-year completers, and 62.3% for 3-year completers. Overall, 50.0% of patients were considered ≥50% responders (achieved ≥50% reduction in 28-day seizure frequency); 55.9% of 1-year completers and 63.0% of 3-year completers were ≥50% responders.
In eligible patients who entered the open-label extension trial, lacosamide was generally well tolerated. For most patients within each yearly completer cohort, seizure reduction was maintained over time.
Three hundred and seventy-six adults with partial-onset seizures taking 1-3 AEDs enrolled following completion of a double-blind trial of adjunctive lacosamide. During open-label treatment, dosage of lacosamide (100-800 mg/day) and/or concomitant AEDs could be adjusted to optimize tolerability and seizure control.
Kaplan-Meier estimates of patient retention were 74.5% at 12 months, 52.9% at 36 months, and 40.6% at 60 months; median open-label treatment duration was 1183 days (~3.2 years). The most frequently reported treatment-emergent adverse events were dizziness (24.2%), headache (14.4%), diplopia (13.8%), and nasopharyngitis (13.8%); 9.0% of patients discontinued due to adverse events, most commonly dizziness (1.3%). Median percent reduction in 28-day seizure frequency from baseline of the double-blind trial was 49.9% overall, 55.4% for 1-year completers, and 62.3% for 3-year completers. Overall, 50.0% of patients were considered ≥50% responders (achieved ≥50% reduction in 28-day seizure frequency); 55.9% of 1-year completers and 63.0% of 3-year completers were ≥50% responders.
In eligible patients who entered the open-label extension trial, lacosamide was generally well tolerated. For most patients within each yearly completer cohort, seizure reduction was maintained over time.
Keywords
lacosamide, open label, partial-onset seizures, responders, safety, tolerability
Pubmed
Web of science
Create date
04/01/2019 16:28
Last modification date
20/08/2019 13:10
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