Defining success in clinical trials--profiling pregabalin, the newest AED

Details

Serval ID
serval:BIB_ACF4E6EBCF73
Type
Article: article from journal or magazin.
Collection
Publications
Title
Defining success in clinical trials--profiling pregabalin, the newest AED
Journal
Eur J Neurol
Author(s)
Ryvlin P.
ISSN
1351-5101 (Print)
ISSN-L
1351-5101
Publication state
Published
Issued date
11/2005
Volume
12 Suppl 4
Pages
12-21
Language
english
Notes
Ryvlin, P
eng
Review
England
Eur J Neurol. 2005 Nov;12 Suppl 4:12-21. doi: 10.1111/j.1468-1331.2005.01327.x.
Abstract
The efficacy and safety of pregabalin as adjunctive therapy for patients with partial epilepsy with or without secondary generalization has been established by four randomized, 12-week, double-blind, placebo-controlled trials (n = 1396) and four long-term open-label studies (n = 1480). Patients in the three fixed-dose trials were >/=12 years of age, had >/=6 partial seizures and no 4-week seizure-free period during the 8-week baseline period. Seventy-three per cent of patients were taking >/=2 concomitant antiepileptic drugs. Responder rates across the effective doses (150-600 mg/day) ranged from 14% to 51% and demonstrated a significant dose-response relationship. The most common adverse events were central nervous system related, generally mild or moderate, transient, and tended to be dose related. The fourth placebo-controlled trial compared a fixed dose of pregabalin 600 mg/day with a flexible-dose regimen (150-600 mg/day). Responder rates were greater for both the fixed dose (45.3%, P < 0.001) and flexible dose (31.3%, P < 0.001) when compared with placebo (11.0%). Compared with the fixed-dose group, the flexible-dose patients had a lower incidence of adverse events and study discontinuations. In long-term open-label trials, the efficacy of pregabalin was maintained with respect to 50% responder rates suggesting no obvious tolerance developing over 2 years. Seizure-free rates were 8.9% and 5.8% for the last 6 months and 1 year of pregabalin treatment, respectively. Long-term open-label pregabalin treatment was well tolerated.
Keywords
Anticonvulsants/adverse effects/*therapeutic use, Clinical Trials as Topic, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Approval, Epilepsy/*drug therapy, Humans, Pregabalin, Treatment Outcome, gamma-Aminobutyric Acid/adverse effects/*analogs & derivatives/therapeutic use
Pubmed
Create date
29/11/2018 12:37
Last modification date
20/08/2019 15:16
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