Pregabalin in partial seizures: a pragmatic 21-week, open-label study (PREPS)

Details

Serval ID
serval:BIB_1117FC1068BE
Type
Article: article from journal or magazin.
Collection
Publications
Title
Pregabalin in partial seizures: a pragmatic 21-week, open-label study (PREPS)
Journal
Eur J Neurol
Author(s)
Ryvlin P., Kalviainen R., Von Raison F., Giordano S., Emir B., Chatamra K.
ISSN
1468-1331 (Electronic)
ISSN-L
1351-5101
Publication state
Published
Issued date
05/2010
Volume
17
Number
5
Pages
726-32
Language
english
Notes
Ryvlin, P
Kalviainen, R
Von Raison, F
Giordano, S
Emir, B
Chatamra, K
eng
Controlled Clinical Trial
Multicenter Study
Research Support, Non-U.S. Gov't
England
Eur J Neurol. 2010 May;17(5):726-32. doi: 10.1111/j.1468-1331.2009.02916.x. Epub 2010 Jan 25.
Abstract
BACKGROUND AND PURPOSE: Pregabalin has demonstrated efficacy in controlled trials as adjunctive treatment in patients with refractory seizures. METHODS: This open-label, 21-week study in adults with at least two partial seizures in the last 2 months, who were inadequately controlled with one to three antiepileptic drugs, evaluated pregabalin 150-600 mg/day (dosed twice daily). The study comprised a prospective or retrospective 8-week baseline phase, and 9-week dose optimization and 12-week maintenance periods. The primary assessment was the mean percentage change in 28-day seizure frequency between baseline and end-point (last 12 weeks of treatment, last observation carried forward, modified intention-to-treat population). RESULTS: Four hundred and seventy-six patients from Europe were included in this study (51% men; mean age/epilepsy duration 40.1/24.1 years). The median baseline seizure frequency was 5.5/28 days. Amongst the patient population, 78% completed the 21-week treatment period; 7% discontinued for lack of efficacy and 12% because of adverse events (AEs). The mean last pregabalin dose was 359 mg/day. The mean (95% CI) reduction in seizure frequency was 36% (31%; 41%). The median reduction was 33%, and 39% of patients had a >or=50% reduction in seizure frequency. There were 19% and 8% of patients free of seizures during their last 4 and 12 weeks of treatment, respectively. The three most common AEs were dizziness (17%), somnolence (13%) and weight increase (13%). CONCLUSIONS: This open-label study of pregabalin demonstrated efficacy that was consistent with that observed in previous controlled epilepsy trials. Pregabalin was well tolerated. The AE profile was also consistent with that reported in previous trials.
Keywords
Adult, Anticonvulsants/*administration & dosage/adverse effects, Dose-Response Relationship, Drug, Drug Administration Schedule, Epilepsies, Partial/*drug therapy, Europe, Female, Humans, Male, Pregabalin, Prospective Studies, Retrospective Studies, Time Factors, Treatment Outcome, gamma-Aminobutyric Acid/administration & dosage/adverse effects/*analogs &, derivatives
Pubmed
Create date
29/11/2018 12:37
Last modification date
20/08/2019 12:38
Usage data