Inoue, Yushi and Tiamkao, Somsak and Zhou, Dong and Cabral-Lim, Leonor and Lim, Kheng Seang and Lim, Shih-Hui and Tsai, Jing-Jane and Moseley, Brian and Wang, Lin and Sun, Weiwei and Hayakawa, Yoshinobu and Sasamoto, Hiroshi and Sano, Tomonobu and Mcclung, Carrie and Bass, Almasa (2024) Efficacy, safety, and tolerability of adjunctive brivaracetam in adult Asian patients with uncontrolled focal-onset seizures: A phase III randomized, double-blind, placebo-controlled trial. Epilepsia Open, 9 (3). pp. 1007-1020. ISSN 2470-9239, DOI https://doi.org/10.1002/epi4.12929.
Full text not available from this repository.Abstract
Objective: The objective was to assess the efficacy and safety of adjunctive brivaracetam (BRV) with concomitant use of lamotrigine (LTG) or topiramate (TPM) in patients with uncontrolled focal seizures. Methods: Data were pooled from three randomized, placebo-controlled Phase III studies (NCT00490035/N01252, NCT00464269/N01253, NCT01261325/N01358) of adults with focal (partial-onset) seizures. Patients taking concomitant levetiracetam were excluded from the efficacy populations, but included in the safety populations. This post-hoc analysis reports data from patients taking BRV in the approved therapeutic range (50-200 mg/day) concomitantly with LTG or TPM. Results: The number of patients in each of the three BRV dosage groups was small, particularly for the TPM subgroup. Mean percent reduction over placebo in baseline-adjusted focal seizure frequency/28 days for BRV 50, 100, and 200 mg/day was 8.7, 5.3, and 8.9 in the LTG subgroup (n = 220), and 8.4, 21.3, and - 4.2 in the TPM subgroup (n = 122). The >= 50% responder rate with concomitant LTG or TPM with BRV 50, 100, and 200 mg/day or placebo was LTG: 28.1%, 36.1%, 34.1%, and 29.1%; and TPM: 14.3%, 44.4%, 25.0%, and 17.5%. There were numerically >= 50%, >= 75%, >= 90%, and 100% responder rates for patients taking BRV >= 50 mg/day compared with placebo in both subgroups. In the LTG and TPM safety populations (n = 245 versus n = 125), treatment-emergent adverse events (TEAEs) were reported with LTG 68.7% versus 68.4%, and TPM 65.6% versus 57.8% (BRV >= 50 mg/day versus placebo). Discontinuations due to TEAEs versus placebo were LTG 7.3% versus 6.3% and TPM 8.2% versus 4.7%. The three most frequently reported TEAEs for both subgroups were somnolence, dizziness, and fatigue. Of these, the incidence of fatigue in the LTG population appeared to increase with dose. Significance: In this post-hoc pooled analysis, BRV administered with concomitant LTG or TPM reduced seizure frequency and was generally well tolerated for BRV doses of 50-200 mg/day.
| Item Type: | Article |
|---|---|
| Funders: | UCB Pharma SA |
| Uncontrolled Keywords: | antiseizure medication; Asian; clinical trial; concomitant medication; focal-onset epilepsy |
| Subjects: | R Medicine |
| Divisions: | Faculty of Medicine > Medicine Department |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 08 Oct 2024 08:26 |
| Last Modified: | 08 Oct 2024 08:26 |
| URI: | http://eprints.um.edu.my/id/eprint/45329 |
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