Levetiracetam in patients with refractory epilepsy: results of the SKATE trial in Austria, Germany and Switzerland.
OBJECTIVE
To further evaluate the safety, efficacy and optimal dose of levetiracetam (LEV) in daily clinical practice among patients with uncontrolled partial epilepsy with or without secondary generalization.


METHODS
In this phase IV, open-label, 16-week community-based study, 178 at least 16-year-old patients with refractory focal epilepsy were treated with 1000, 2000 or 3000 mg levetiracetam as adjunctive therapy. All patients started with 500 mg LEV b.i.d. (1000 mg/day); the dose was adjusted in 2-week intervals up to 1500 b.i.d. (3000 mg/day) depending on seizure control and tolerability. The main objectives were the adverse events, the percentage reduction in partial and total seizure frequency per week from baseline and the retention rate, defined as the percentage of patients taking LEV at the end of the 16-week treatment period.


RESULTS
Of the 178 patients who took at least one dose of LEV 151 completed the study. Thus, the retention rate (number of patients taking LEV at the end of the 16-week treatment period) was 84.8%. Most frequently reported adverse events were asthenia, dizziness, headache, nausea, somnolence and hostility; the majority of these events were of mild to moderate intensity. The seizure-free rate of the ITT population with focal seizures was 16.7%, for all seizures 16.6%; the median reduction of focal seizure frequency was 47.6%, and 46.5% for all seizures. The 50% responder rate was 46.6% for focal seizures and 45.1% for all seizures.


CONCLUSIONS
Add-on treatment with LEV in patients with refractory partial epilepsy was safe and effective in this study.
Steinhoff
Bernhard J
BJ
Epilepsiezentrum Kork, Department of Adults, Landstrasse 1, 77694 Kehl-Kork, Germany. bsteinhoff@epilepsiezentrum.de
Trinka
Eugen
E
Wieser
Heinz-Gregor
HG
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000627:therapeutic use*; D001317:Austria / Q000453:epidemiology; D003710:Demography; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D010889:Piracetam / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013557:Switzerland / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam