IngentaConnect Levetiracetam: a long-term follow-up study of efficacy and safety

Authors: Bauer, J.¹; Ben-Menachem, E.²; Krämer, G.³; Fryze, W.⁴; Da Silva, S.⁵; Kasteleijn-Nolst Trenité, D. G. A.⁶

Source: Acta Neurologica Scandinavica, Volume 114, Number 3, September 2006 , pp. 169-176(8)

Abstract:

Bauer J, Ben-Menachem E, Krämer G, Fryze W, Da Silva S, Kasteleijn-Nolst Trenité DGA. Levetiracetam: a long-term follow-up study of efficacy and safety.

To evaluate the efficacy and safety of long-term add-on treatment with levetiracetam 1,000-4,000 mg/day. Patients and methods -

In this multicenter, open-label follow-up study, 505 patients, from 10 European countries, who had benefited from previous add-on treatment with levetiracetam in a clinical trial or compassionate-use program were enrolled; 274 (54.3%) stayed to the end. Most then continued levetiracetam by prescription or in a named patient program, where it was not yet commercially available. Mean treatment duration was 1,045 days (range: 24 days to >7 years). Median daily dosage was 3,000 mg/day (range: 250-6,000 mg/day), with 250 (49.5%) patients receiving levetiracetam for >3 years. Results -

Median total and partial seizure frequency per week over the evaluation period were 0.8 and 0.7; seizure frequency per week was generally stable over time and remained low. There was a probability of 6.6% of remaining seizure-free for the first 3 years, and of 18.9% of having a seizure-free period of at least 3 years at any time. Most adverse events were mild or moderate and unrelated to study drug. Levetiracetam was well tolerated, and provided stable seizure control during long-term treatment.

Keywords: add-on therapy; antiepileptic drug; epilepsy; long-term treatment; levetiracetam; seizure frequency

Document Type: Research article

DOI: 10.1111/j.1600-0404.2006.00657.x

Affiliations: 1: Universitätsklinikum Bonn, Klinik für Epileptologie, Bonn, Germany 2: Department of Clinical Neuroscience, Sahlgren University Hospital, Göteborg, Sweden 3: Swiss Epilepsy Centre, Zürich, Switzerland 4: Oddzial Neurologii, Wojewodzki Szpital, Gdansk, Poland 5: Clinical Development Europe, UCB Pharma, Braine-l'Alleud, Belgium 6: Medical Center Alkmaar, Alkmaar, the Netherlands

The full text electronic article is available for purchase. You will be able to download the full text electronic article after payment.

$50.39 plus tax Refund Policy