Purpose: To evaluate the short-term effect of levetiracetam (LEV; UCB L059)
as add-on therapy on health-related quality of hfe in the treatment of ref
ractory partial-onset seizures.
Methods: Patients were enrolled in protocol UCB N132 if they had greater th
an or equal to 12 partial-onset seizures with or without secondary generali
zation during the 12-week baseline period with a minimum of two seizures ev
ery 4 weeks. Randomization was made to placebo, LEV 1,000 mg, or LEV 3,000
mg,with sample size based on seizure frequency reduction. The 31-item Quali
ty of Life in Epilepsy (QOLIE-31) questionnaire was completed by 246 patien
ts at the end of baseline and at 18-week follow-up, or earlier if withdrawn
.
Results: Significant differences were found among the three treatment group
s for Seizure Worry (p = 0.0003), Overall Quality of Life (p = 0.04), and C
ognitive Functioning domains (p = 0.01), as well as the Total Score (p = 0.
009). Responders (greater than or equal to 50% partial onset seizure reduct
ion) had significant improvements in all areas, except Medication Effect, c
ompared with nonresponders (all p > 0.006). Clinically noticeable improveme
nt (greater than or equal to 10% change from baseline to follow-up) was per
ceived by LEV 3,000 mg responders in all areas, except Emotional Well-Being
, by LEV 1,000 mg responders in 5 of 9 areas, and by placebo responders in
2 of 9 areas.
Conclusions: Addition of LEV to standard medication seems to have a positiv
e impact on health-related quality of life, particularly among responders i
n this short-term study. These exploratory analyses require additional stud
ies to evaluate longterm changes in a larger population.