Effect of levetiracetam on epilepsy-related quality of life. N132 Study Group.
OBJECTIVE
To evaluate the short-term effect of levetiracetam (LEV; UCB L059) as add-on therapy on health-related quality of life in the treatment of refractory partial-onset seizures.


METHODS
Patients were enrolled in protocol UCB N132 if they had >/=12 partial-onset seizures with or without secondary generalization during the 12-week baseline period with a minimum of two seizures every 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 Quality of Life in Epilepsy (QOLIE-31) questionnaire was completed by 246 patients at the end of baseline and at 18-week follow-up, or earlier if withdrawn.


RESULTS
Significant differences were found among the three treatment groups for Seizure Worry (p = 0. 0003), Overall Quality of Life (p = 0.04), and Cognitive Functioning domains (p = 0.01), as well as the Total Score (p = 0.009). Responders (>/=50% partial onset seizure reduction) had significant improvements in all areas, except Medication Effect, compared with nonresponders (all p > 0.006). Clinically noticeable improvement (>/=10% change from baseline to follow-up) was perceived 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 positive impact on health-related quality of life, particularly among responders in this short-term study. These exploratory analyses require additional studies to evaluate long-term changes in a larger population.
Cramer
J A
JA
Departments of Psychiatry and Neurology, Yale University School of Medicine, New Haven, Connecticut, USA. Joyce.Cramer@Yale.Edu
Arrigo
C
C
Van Hammée
G
G
Gauer
L J
LJ
Cereghino
J J
JJ
D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D006305:Health Status Indicators; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010919:Placebos; D011788:Quality of Life; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000927:Anticonvulsants; D010919:Placebos; D000077287:Levetiracetam; D010889:Piracetam