A randomized, open-label, multicenter comparative trial of levetiracetam and topiramate as adjunctive treatment for patients with focal epilepsy in Korea
- Authors
- Lee, Sang Kun; Le, Sang Ahm; Kim, Dong Wook; Loesch, Christian; Pelgrims, Barbara; Osakabe, Toru; Lee, Byungin; Cho, Yong-Won; Park, Sung-Pa; Heo, Kyoung; Hong, Bong Seung; Kim, Dong-Wook; Kim, Ji Hyun; Song, Hong-Ki; Shon, Young Min; Kim, Young In; Kim, Woo Jun; Kim, Bo Mi; Fang, Sang-Hyun; Kim, Jae Moon; Ji, KiHwan; Kim, Sang-Ho; Kim, Sung Eun; Son, Je Yong; No, Soon Kee; Kim, Kwang-Ki; Song, Pamela; Park, Hee Kyung; Kim, Myeong Kyu; Kim, Joo-Yong; Kim, OkJoon; Lee, Eun Mi; Lim, Sung-Chul; Shin, Dong-Jin
- Issue Date
- 8월-2019
- Publisher
- ACADEMIC PRESS INC ELSEVIER SCIENCE
- Keywords
- Partial-onset seizures; Antiepileptic drugs; Add-on
- Citation
- EPILEPSY & BEHAVIOR, v.97, pp.67 - 74
- Indexed
- SCIE
SCOPUS
- Journal Title
- EPILEPSY & BEHAVIOR
- Volume
- 97
- Start Page
- 67
- End Page
- 74
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/64042
- DOI
- 10.1016/j.yebeh.2019.05.014
- ISSN
- 1525-5050
- Abstract
- Objective: The objective of this trial was to compare the effectiveness of levetiracetam (LEV) and topiramate (TPM) as adjunctive treatment for patients with focal seizures in Korea. Methods: In this Phase IV, open-label, multicenter trial (NCT01229735), adults were randomized to treatment with LEV (1000-3000 mg/day) or TPM (200-400 mg/day). Only patients achieving LEV >= 1000 mg/day or TPM >= 100 mg/day after a 4-week up-titration entered the 20-week dose-finding and subsequent 28-week maintenance periods. The primary outcome was the 52-week retention rate; others included safety and exploratory efficacy outcomes. Results: Of343 randomized patients (LEV 177; TPM 166), 211 (61.5%) completed the trial. In the full analysis set (FAS), retention rate was 59.1% with LEV vs 56.6% with TPM (p = 0.7007), while in the prespecified sensitivity analysis, based on data from patients who received drug doses in the recommended range (LEV 176; TPM 113), it was 59.1% with LEV vs 42.5% with TPM (p = 0.0086). In the FAS, median percent reduction in seizure frequency from baseline was 74.47% with LEV and 67.86% with TPM (p = 0.0665); 50% responder rate was 69.0% vs 64.8% (p = 0.4205), and the 6-month seizure-freedom rate was 35.8% vs 22.3% (p = 0.0061). In the sensitivity analysis, differences between groups were greater, favoring LEV. Incidences of treatment-emergent adverse events (TEAEs) were 70.6% with LEV vs 77.1% with TPM; most frequently somnolence (20.3%), dizziness (18.1%), and nasopharyngitis (13.6%) with LEV; and decreased appetite (15.7%), dizziness (14.5%), and headache (145%) with TPM. Discontinuations due to TEAEs were 7.9% with LEV and 12.7% with TPM. Conclusions: In this open-label trial, the 52-week retention rate was not significantly different between LEV and TPM. However, LEV was associated with a substantially higher seizure freedom rate and a more favorable safety profile than TPM in this population of Korean patients with focal seizures. (C) 2019 Published by Elsevier Inc.
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