A Pooled Analysis of Lacosamide Clinical Trial Data Grouped by Mechanism of Action of Concomitant Antiepileptic Drugs
| Autor: | Jouko I. T. Isojärvi, Kendra Davies, David Hebert, Andrea Eggert-Formella, Pamela Doty, John-Kenneth Sake, Marc De Backer, James Zackheim |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Lacosamide Population Pharmacology Lamotrigine Placebo Clinical Trials Phase II as Topic Double-Blind Method Internal medicine Acetamides medicine Humans Pharmacology (medical) Oxcarbazepine education Randomized Controlled Trials as Topic education.field_of_study Dose-Response Relationship Drug business.industry Carbamazepine Middle Aged Psychiatry and Mental health Treatment Outcome Clinical Trials Phase III as Topic Concomitant Adjunctive treatment Anticonvulsants Drug Therapy Combination Female Epilepsies Partial Neurology (clinical) business Sodium Channel Blockers medicine.drug |
| Zdroj: | CNS Drugs. 24:1055-1068 |
| ISSN: | 1172-7047 |
| DOI: | 10.2165/11587550-000000000-00000 |
| Popis: | Background: Lacosamide, a new antiepileptic drug (AED) with a different pharmacological action that enhances sodium channel slow inactivation, is approved for the adjunctive treatment of partial-onset seizures in adults. Previous analyses of pooled phase II/III trials have demonstrated that lacosamide provides additional efficacy when added to a broad range of AEDs. Objective: To further evaluate the efficacy and safety of lacosamide by grouping patients based upon the sodium channel-blocking properties of their concomitant AEDs. Study Design: Post hoc exploratory analyses were performed on pooled data in which patients were grouped based upon inclusion or non-inclusion of at least one ‘traditional’ sodium channel-blocking AED (defined as carbamazepine, lamotrigine, oxcarbazepine and phenytoin derivatives) as part of their concomitant AED regimen. Setting: Data pooled from previously conducted phase II/III clinical trials of lacosamide. Patients: Adult patients with partial-onset seizures with or without secondary generalization (N = 1308). Intervention: Four- to six-week Titration Phase followed by 12-week maintenance treatment with adjunctive lacosamide (Vimpat®) [200, 400 or 600 mg/day] or placebo. Main Outcome Measure: Efficacy variables included change in seizure frequency per 28 days and the proportion of patients experiencing a ≥50% reduction in seizure frequency (50% responder rate) from Baseline to the Maintenance Phase. The proportion of patients experiencing a ≥75% reduction in seizure frequency from Baseline to the Maintenance Phase (75% responder rate) was also assessed. Safety parameters assessed were treatment-emergent adverse events (TEAEs) and discontinuation due to TEAEs. Additional safety assessments were changes in ECG and laboratory parameters as well as vital signs (including bodyweight). Results: Of 1308 patients in the pooled phase II/III population, the majority (82%) were using at least one ‘traditional’ sodium channel-blocking concomitant AED. In this subgroup of patients, adjunctive lacosamide showed significant reductions in seizure frequency (p |
| Databáze: | OpenAIRE |
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