Abstracts

RATIONALE: To assess the compliance and treatment preference in patients with epilepsy, already established on valproate enteric coated (EC) tablets (Depakine EC[Sanofi-Synthelabo]) regime when switched to the same total daily dose of valproate sustained release (Depakine Chrono [Sanofi-Synthelabo]).
METHODS: A prospective, observational, non-randomised, multicentre and multinational study comparing valproate EC and sustained release formulation in patients with epilepsy established on valproate EC from 3 months at least before the study entry.
Patients were switched to valproate sustained release.
Clinical parameters and a self-completed questionnaire about the compliance and satisfaction were asked at the inclusion visit and at a second visit 3 months after.In this communication, first results from Spanish centers are presented.
RESULTS: A total of 104 patients were recruited into the study in 25 Spanish centres, of whom 94 (aged 18-65 years) fulfilled the inclusion criteria.
After three months follow-up, VPA levels (n = 53) moved from 82.5 mg/l (S.D. 15.9)to 78.2 mg/l (S.D. 19.45), which showed non-significant difference from the baseline.
Patient satisfaction with intake frequency moved from a 12.8% very satisfied and 33% satisfied patients in the baseline visit to a 52.2% very satisfied and 42.2% satisfied patients after 3 months (Wilcoxon Rank test p [lt] 0.05).
Patient reported adverse events decreased significatively (p = or [lt] 0.05) in 10 out of 20 areas (unsteadiness, tiredness, restlessness, feelings of aggression, nervousness and/or agitation, shaky hands, sleepiness, depression, disturbed sleep, difficulty in thinking clearly).
Perceived seizure control improved from 36.6% [dsquote]extremely well[dsquote] and 54.8% [dsquote]well controlled[dsquote] patients at baseline visit to a 51.7% [dsquote]extremely well[dsquote] and 42.7% [dsquote]well controlled[dsquote] patients after 3 months (Wilcoxon Rank test p [lt] 0.05).
Reported compliance of patients who said that they never forget to take their medication improved from 44.7% at baseline to 83.3% at 3 months follow-up visit (Wilcoxon Rank test p [lt] 0.05).
CONCLUSIONS: Sustained release valproic acid once daily appears to improve compliance and patient satisfaction without adversely affecting VPA levels and seizure control. Adverse effects were significantly less likely to be reported when compared to traditional three-times a day VPA tablets.
Support: Sanofi-Synthelabo
Disclosure: Grant - Educational Research; Grant- Sanofi-Synthelabo. Consulting - Yes- 5000.