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Efficacy and Safety of Levetiracetam (up to 2000 mg/day) in Taiwanese Patients with Refractory Partial Seizures: A Multicenter, Randomized, Double‐blind, Placebo‐controlled Study
Author(s) -
Tsai JingJane,
Yen DerJen,
Hsih MoSong,
Chen ShungSheng,
Hiersemenzel Reinhard,
Edrich Pascal,
Lai ChiWan
Publication year - 2006
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1167.2006.00372.x
Subject(s) - discontinuation , medicine , placebo , levetiracetam , adverse effect , refractory (planetary science) , population , odds ratio , anesthesia , epilepsy , psychiatry , physics , alternative medicine , environmental health , pathology , astrobiology
Summary: Purpose: To assess the efficacy and safety of adjunctive levetiracetam (LEV) therapy in controlling partial‐onset seizures refractory to other antiepileptic drugs (AEDs) in a multicenter study in Taiwanese adults. Methods: Ninety‐four patients aged 16–60 years with refractory partial seizures were randomized to receive LEV (n = 47) or placebo (47) for 14 weeks and composed the intention‐to‐treat (ITT) population. After the first 2 weeks, LEV patients had their dosage increased from 500 mg twice daily to 1,000 mg twice daily. A 12‐week maintenance phase followed, after which patients switched to long‐term, open‐label LEV therapy or entered a 4‐week phase of medication discontinuation. Results: All patients from the ITT population, except one LEV‐treated patient with missing seizure‐count data, were included in the primary efficacy analysis. The least square mean of logarithmically transformed weekly partial‐seizure frequency was significantly lower in the LEV than in the placebo group (0.813 vs. 1.085; p = 0.001). LEV reduced log‐transformed weekly partial‐seizure frequency by 23.8% (95% confidence interval, 10.4–35.2%) relative to placebo. Significantly more LEV than placebo patients (43.5% vs. 10.6%) experienced a response of a ≥50% decrease from baseline in weekly frequency of partial seizures [odds ratio, 6.5 (95% CI, 2.2–19.3); p < 0.001]. Adverse events were reported in 34 (72.3%) of 47 LEV‐treated patients and 32 (68.1%) of 47 placebo patients. The three most common adverse events in the LEV and placebo groups were somnolence (40.4% and 14.9%), dizziness (14.9% and 8.5%), and headache (10.6% and 8.5%), respectively. Only four patients (three LEV‐treated patients and one placebo patient) were withdrawn from the study because of adverse events. Conclusions: Adjunctive LEV therapy, ≤1,000 mg twice daily, was significantly more effective than placebo and was generally well tolerated in Taiwanese adults with treatment‐resistant partial‐onset seizures.