Details

Autor(en) / Beteiligte

• Rosenow, F.
• Kelemen, A.
• Ben-Menachem, E.
• McShea, C.
• Isojarvi, J.
• Doty, P.

Titel

Long-term adjunctive lacosamide treatment in patients with partial-onset seizures

Ist Teil von

• Acta neurologica Scandinavica, 2016-02, Vol.133 (2), p.136-144

Ort / Verlag

Denmark: Blackwell Publishing Ltd

Erscheinungsjahr

2016

Quelle

Psychology & Behavioral Sciences Collection

Beschreibungen/Notizen

• Objective 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). Methods 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. Results 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. Conclusion 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.