Long-Term Effects of Levetiracetam on Health-Related Quality of Life
Abstract number :
3.085
Submission category :
Year :
2001
Submission ID :
2750
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
J. Cramer, VA Connecticut Health Care System, Yale University School of Medicine, West Haven, CT; G. Van Hammée, Clinical Epidemiology & Outcomes Research, UCB Pharma, Braine l[ssquote]Alleud, Belgium; M.G. Katos, Clinical Development, UCB Pharma, Inc., S
RATIONALE: To investigate health-related quality of life (HRQOL) among patients with frequent partial-onset seizures during long-term follow-up after a clinical trial.
METHODS: Patients were initially randomized to levetiracetam (LEV) or placebo add-on therapy in an 18 week clinical trial. Those who continued on LEV or crossed from placebo to LEV were followed approximately 4 years. Among those, a total of 101 patients completed the QOLIE-31 at baseline, 18 weeks, and long-term, and were included in analyses. Scale scores were compared between periods (paired t-tests), and between groups starting with LEV or placebo (ANCOVA).
RESULTS: When considering the group of 101 patients, QOLIE-31 scores improved in all subscales between baseline and long-term follow-up: seizure worry 9.5 (p = 0.0002), overall QOL 5.6 (p = 0.002), emotions 0.1 (ns), energy 4.1 (p = 0.05), cognition 2.3 (ns), medication effects 4.2 (ns), social function 5.9 (p = 0.04), health status 8.5 (p = 0.0001), total score 3.8 (p = 0.01). Comparisons between groups starting either with LEV or placebo showed no significant differences in QOLIE-31 scale changes from baseline to 4 years, indicating that the two groups reached the same level of improvement in HRQOL at long-term follow-up. Patients randomized on LEV (N = 66) had significantly better scores than patients on placebo at week 18, for 3 domains (seizure worry, overall QOL and health status) and total score. Scores remained stable with no additional significant changes (improvements or declines) during 4 year follow-up after entering open-label LEV. Improvements in patients randomized on placebo (N = 35) took place after starting LEV, with significant changes at long-term follow-up in seizure worry (p = 0.0003), cognition (p = 0.03), social function (p = 0.02), and total score (p = 0.0002).
CONCLUSIONS: Early improvements in selected HRQOL areas were sustained over several years of LEV treatment. Patients starting LEV during or after the main clinical trial achieved similar improvements during long-term follow-up.
Support: A grant from UCB Pharma.
Disclosure: Consulting - UCB Pharma. Honoraria - UCB Pharma.