|Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in Chinese patients with refractory partial-onset seizures|
|Wu, Xun-Yi1; Hong, Zhen; Wu, Xun2; Wu, Li-Wen3; Wang, Xue-Feng4; Zhou, Dong5; Zhao, Zhong-Xin6; Lv, Chuan-Zhen|
|关键词||Levetiracetam Epilepsy Add-on therapy Partial-onset seizures Refractory seizures Chinese patients|
|WOS标题词||Science & Technology|
|研究领域[WOS]||Neurosciences & Neurology|
|关键词[WOS]||IDIOPATHIC GENERALIZED EPILEPSY ; PHARMACOKINETICS ; EFFICACY ; BINDING ; PROTEIN ; SV2A ; DRUG|
Purpose: To evaluate efficacy and tolerability of levetiracetam (LEV; Keppra (R)) as add-on therapy in Chinese patients with refractory partial-onset seizures.
Methods: In this multicenter, double-blind, randomized, placebo-controlled trial, 206 patients aged 16-70 years with uncontrolled partial-onset seizures were randomized to receive LEV (n = 103) or placebo (n 103); 202 patients (LEV, n 102; placebo, n 100) comprised the intent-to-treat population. An 8-week historical baseline period confirmed eligibility according to seizure count. The 16-week treatment period consisted of a 4-week up-titration period (LEV, 1,000-3,000 mg/day in two equal divided doses) followed by a 12-week maintenance period. Efficacy assessments were based on weekly frequency of partial-onset seizures during the 16-week treatment period.
Results: LEV significantly decreased weekly partial-onset seizure frequency over placebo by 26.8% (p < 0.001). Median percentage reductions in weekly partial-onset seizure frequency from historical baseline were 55.9% for LEV and 13.7% for placebo (p < 0.001). The 50% responder rates were 55.9% for LEV, compared with 26.0% for placebo (p < 0.001). Freedom from partial-onset seizures during treatment period was achieved by 11 LEV patients (10.8%) and 2 placebo patients (2.0%) (p = 0.012). Adverse events were reported by 65 LEV-treated patients (63.1%) and 62 placebo-treated patients (60.2%); most were of mild-to-moderate intensity. The most common adverse events were somnolence (LEV, 17.5%; placebo, 17.5%), decreased platelet count (LEV, 9.7%; placebo, 9.7%), and dizziness (LEV, 7.8%; placebo, 13.6%).
Discussion: Add-on LEV was effective and well-tolerated in Chinese patients with refractory partial-onset seizures.
|资助机构||UCB Pharma SA|
|作者单位||1.Fudan Univ, Inst Neurol, Huashan Hosp, Shanghai Med Coll, Shanghai 200433, Peoples R China|
2.Peking Univ, Hosp 1, Dept Neurol, Beijing, Peoples R China
3.Peking Xiehe Hosp, Peking Union Med Coll, Dept Neurol, Beijing, Peoples R China
4.Chongqing Univ Med Sci, Affiliated Hosp, Dept Neurol, Chongqing, Peoples R China
5.Sichuan Univ, W China Hosp, Dept Neurol, Chengdu 610064, Peoples R China
6.Second Mil Med Univ, Dept Neurol, Shanghai Changzheng Hosp, Shanghai, Peoples R China
|Wu, Xun-Yi,Hong, Zhen,Wu, Xun,et al. Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in Chinese patients with refractory partial-onset seizures[J]. EPILEPSIA,2009,50(3):398-405.|
|APA||Wu, Xun-Yi.,Hong, Zhen.,Wu, Xun.,Wu, Li-Wen.,Wang, Xue-Feng.,...&Lv, Chuan-Zhen.(2009).Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in Chinese patients with refractory partial-onset seizures.EPILEPSIA,50(3),398-405.|
|MLA||Wu, Xun-Yi,et al."Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in Chinese patients with refractory partial-onset seizures".EPILEPSIA 50.3(2009):398-405.|