Efficacy and safety of levetiracetam for adult seizure: A randomized controlled trial / 第二军医大学学报

ABSTRACT

Objective To evaluate the efficacy and safety of levetiracetam (LTA) for adult seizure (AS). Methods A randomized, double-blinded, double-dummy, positive drug controlled trial was conducted. One hundred and twenty eligible AS patients were randomly divided into two groups: intervention group and control group, with 60 in each group. Patients in the intervention group received LTA tablet plus valproate sodium mimetic tablet, and patients in the control group received valproate sodium tablet and LTA mimetic tablet. The treatment course was 26 weeks in both groups, and the patients was followed up for 3 months after the treatment. The outcomes included total efficacy rate, weekly epilepsy seizure frequency, seizure duration, quality of life (measured by QOLIE-31 Scale) and adverse events related to drugs after 1-3 days of treatment and at 3 months of follow-up. Results The weekly epilepsy seizure frequency, seizure duration and QOLIE-31 score were not significantly different between the two groups before treatment. The total efficacy rates after treatment and at 3 months of follow-up in the intervention group were 95. 0% (57/60) and 91 7% (55/60), respectively, and were significantly higher than those in the control group of 71 7% (43/60) and 63. 3% (38/60) (P<0 01). The weekly epilepsy seizure frequency, seizure duration and QOLIE-31 score after treatment and at 3 months of follow-up were significantly different as compared with before treatment in both groups (P<3. 01); and there were significantly different between the two groups (P<3 01). The adverse events after treatment were similar between both groups. Conclusion The efficacy of LAT is superior to the valproate sodium tablet for AS, with the less toxicity, and it can be clinical drug of choice for AS.