Abstracts

CLINICAL EXPERIENCE WITH LEVETIRACETAM: A PROSPECTIVE OBSERVATIONAL STUDY

Abstract number : 2.199
Submission category :
Year : 2002
Submission ID : 2175
Source : www.aesnet.org
Presentation date : 12/7/2002 12:00:00 AM
Published date : Dec 1, 2002, 06:00 AM

Authors :
Rajiv Mohanraj, Pamela G. Parker, Kevin Kelly, Linda J. Stephen, Graeme J. Sills, Martin J. Brodie. Epilepsy Unit, University Department of Medicine and Therapeutics, Western Infirmary, Glasgow, Scotland, United Kingdom

RATIONALE: Levetiracetam (LEV), the S- enantiomer of the ethyl analogue of piracetam, is a novel antiepileptic drug (AED) that has been licensed in the UK as add-on therapy in patients with partial and/or secondary generalised seizures since January 2001. The objectives of this study were to explore its efficacy and tolerability as adjunctive treatment in everyday clinical practice.
METHODS: LEV was added to the existing regime in patients with difficult-to-control epilepsy of any seizure type. The major efficacy end points were seizure freedom for 6 months on an unchanged dose of LEV, [gt]50% reduction in seizure frequency compared to a 3 month prospective baseline period (responder) at optimal dosage, or discontinuation due to adverse effects, lack of efficacy or both.
RESULTS: To date, 132 patients have been recruited with 77 having reached an end point. Of these, 23 were seizure free and 16 could be classed as responders. Overall, 34 patients had LEV withdrawn within the first few months of initiation of therapy (19 side-effects, 12 lack of efficacy, 3 worsening of seizures). Of the 19 patients reporting intolerable side-effects, 14 complained of sedation. 18 of 38 patients with learining disability reached an end-point, 6 of whom were seizure free and a further 6 had [gt]50% seizure reduction. Analysis by seizure types and concomitant AEDs will be discussed and the daily LEV doses and serum concentrations will be correlated with outcome.
CONCLUSIONS: LEV is efficacious adjunctive treatment in clinical practice with a significant number of patients experiencing remission of 6 months or more. Sedation was the commonest reason for discontinuation.
[Supported by: The study was supported by an unrestricted grant from UCB Pharma]; (Disclosure: Grant - Unrestricted grant from UCB Pharma, Consulting - UCB Pharma, Honoraria - UCB Pharma)