Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis
Autor: | Sang-Ahm Lee, Cédric Laloyaux, Boeun Hur, Sung Eun Kim, Sang-Kun Lee, Sami Elmoufti, Kyoung Heo |
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Rok vydání: | 2021 |
Předmět: |
Adult
030213 general clinical medicine medicine.medical_specialty Brivaracetam Placebo 03 medical and health sciences 0302 clinical medicine Double-Blind Method Seizures Internal medicine Post-hoc analysis Medicine Humans Pharmacology (medical) Adverse effect business.industry General Medicine Odds ratio Pyrrolidinones Discontinuation Treatment Outcome Tolerability 030220 oncology & carcinogenesis Concomitant Anticonvulsants Drug Therapy Combination business medicine.drug |
Zdroj: | Advances in therapy. 38(7) |
ISSN: | 1865-8652 |
Popis: | The aim was to evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with severely drug-resistant focal seizures versus adults with less drug-resistant disease. Data were pooled from patients with focal seizures on 1–2 concomitant antiseizure medications (ASMs) randomized to BRV 50, 100, 200 mg/day, or placebo in 3 phase 3 trials (N01252 [NCT00490035], N01253 [NCT00464269], and N01358 [NCT01261325]) with a 12-week treatment period. Outcomes were assessed in patients with ≥ 5 and 0–4 previous ASMs (stopped before trial drug initiation). In ≥ 5 previous ASMs subgroup (BRV 50, 100, 200 mg/day: n = 26, n = 137, n = 120; placebo: n = 151), percentage reduction over placebo in 28-day adjusted focal seizure frequency was 13.0% for 50 mg/day (p = 0.38), 18.1% for 100 mg/day (p = 0.006), 19.8% for 200 mg/day (p = 0.004), and 17.0% for all BRV-treated patients (p = 0.001). The 50% responder rate was 26.9%, 29.9%, 30.0%, and 29.7% for BRV 50, 100, 200, and 50–200 mg/day, respectively (placebo: 13.2%); odds ratios versus placebo were statistically significant (p |
Databáze: | OpenAIRE |
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