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Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis
DC Field | Value | Language |
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dc.contributor.author | 허경 | - |
dc.date.accessioned | 2022-11-24T00:39:13Z | - |
dc.date.available | 2022-11-24T00:39:13Z | - |
dc.date.issued | 2021-07 | - |
dc.identifier.issn | 0741-238X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190862 | - |
dc.description.abstract | Introduction: 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. Methods: 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). Results: 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 < 0.05) for BRV 100, 200, and 50-200 mg/day. In 0-4 previous ASMs subgroup (BRV 50, 100, 200 mg/day: n = 135, n = 195, n = 129; placebo: n = 267), all BRV dosages showed statistically significant (1) percentage reduction over placebo in 28-day adjusted focal seizure frequency (21.4-28.7%); (2) differences from placebo in median percentage reduction in 28-day adjusted focal seizure frequency from baseline (35.5-45.9%; placebo: 21.3%); and (3) odds ratios versus placebo (favoring BRV) for 50% responder rates. In BRV-treated patients, treatment-emergent adverse event (TEAE) incidence (73.8% [217/294] vs. 64.6% [329/509]) and discontinuation due to TEAEs (10.5% vs. 4.5%) were higher in the ≥ 5 versus 0-4 previous ASMs subgroup; serious TEAEs were rare in both subgroups (≥ 5 previous ASMs: 3.1%; 0-4 previous ASMs: 2.9%). Conclusion: Adjunctive BRV showed efficacy and was generally well tolerated in adults with focal seizures independent of the number of previous ASMs. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Health Communications | - |
dc.relation.isPartOf | ADVANCES IN THERAPY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Anticonvulsants* / adverse effects | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Pyrrolidinones | - |
dc.subject.MESH | Seizures* / drug therapy | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Neurology (신경과학교실) | - |
dc.contributor.googleauthor | Sang-Kun Lee | - |
dc.contributor.googleauthor | Kyoung Heo | - |
dc.contributor.googleauthor | Sung-Eun Kim | - |
dc.contributor.googleauthor | Sang-Ahm Lee | - |
dc.contributor.googleauthor | Sami Elmoufti | - |
dc.contributor.googleauthor | Cédric Laloyaux | - |
dc.contributor.googleauthor | Boeun Hur | - |
dc.identifier.doi | 10.1007/s12325-021-01816-5 | - |
dc.contributor.localId | A04341 | - |
dc.relation.journalcode | J00048 | - |
dc.identifier.eissn | 1865-8652 | - |
dc.identifier.pmid | 34155568 | - |
dc.identifier.url | https://link.springer.com/article/10.1007/s12325-021-01816-5 | - |
dc.subject.keyword | Anti-epileptic drugs | - |
dc.subject.keyword | Antiseizure medications | - |
dc.subject.keyword | Brivaracetam | - |
dc.subject.keyword | Drug-resistant epilepsy | - |
dc.subject.keyword | Drug-resistant focal seizures | - |
dc.subject.keyword | Efficacy | - |
dc.subject.keyword | Focal epilepsy | - |
dc.subject.keyword | Tolerability | - |
dc.contributor.alternativeName | Heo, Kyoung | - |
dc.contributor.affiliatedAuthor | 허경 | - |
dc.citation.volume | 38 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 4082 | - |
dc.citation.endPage | 4099 | - |
dc.identifier.bibliographicCitation | ADVANCES IN THERAPY, Vol.38(7) : 4082-4099, 2021-07 | - |
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