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Pregabalin add-on therapy using a flexible, optimized dose schedule in refractory partial epilepsies: A double-blind, randomized, placebo-controlled, multicenter trial

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Author(s)
Byung In LeeSangdoe YiSeung Bong HongMyeong-Kyu KimSang Ahm LeeSang Kun LeeDong-Jin ShinJae Moon KimHong Ki SongKyoung HeoWing LoweTeresa Leon
Keimyung Author(s)
Yi, Sang Do
Department
Dept. of Neurology (신경과학)
Journal Title
Epilepsy
Issued Date
2009
Volume
50
Issue
3
Abstract
SUMMARY
Purpose: To evaluate the efficacy and safety of
pregabalin (PGB) as adjunctive therapy, using a
flexible-dosing schedule in Korean patients with
refractory partial-onset seizures.
Methods: This randomized, double-blind (DB),
placebo-controlled trial consists of a 6-week baseline,
a 12-week DB treatment, and a 1-week taper
phase. Patients having recurrent partial seizures
(‡4 seizures during baseline phase) under adequate
pharmacotherapy were recruited to be randomized
to PGB or placebo (PLC) in a 2 to 1 ratio.
Starting dose was 150 mg/day, increased every
2 weeks by 150-mg/day increments up to maximum
dose of 600 mg/day. The primary efficacy
parameter was response ratio (RRatio) for all
partial seizures.
Results: A total of 178 patients (119 in PGB, 59 in
PLC) were assigned to the study. Median daily
doses of PGB and PLC were 367 and 420 mg/day,
respectively. RRatio least squares (LS) mean was
)35.8 in the PGB group and )23.2 in the PLC
group, with estimated difference in RRatios being
)12.6 [95% confidence interval (CI): )22.7 to )2.5,
p = 0.015] in the intent-to-treat (ITT) population.
Analysis of secondary efficacy measures showed a
general trend favoring PGB over PLC. Seventyseven
patients (64.7%) in the PGB group and 18
patients (30.5%) in the PLC group developed
adverse events (AEs) related to the study drug.
Seven patients (5.9%) in the PGB group discontinued
the study prematurely because of AEs. In the
post hoc analysis, a significant weight gain (‡7% of
baseline body weight) was found in 24.8% of
patients taking PGB, which was more frequent in
patients with a lower body mass index (BMI £20).
Discussion: PGB was effective and easily tolerable
as add-on treatment in an Asian population with
refractory partial-onset seizures.
KEY WORDS: Pregabalin, Flexible-dosing schedule,
Response ratio, Add-on therapy, Tolerability
Keimyung Author(s)(Kor)
이상도
Publisher
School of Medicine
Citation
Byung In Lee et al. (2009). Pregabalin add-on therapy using a flexible, optimized
dose schedule in refractory partial epilepsies:
A double-blind, randomized, placebo-controlled,
multicenter trial. Epilepsy, 50(3), 464–474. doi: 10.1111/j.1528-1167.2008.01954.x
Type
Article
ISSN
0013-9580
Source
https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1528-1167.2008.01954.x
DOI
10.1111/j.1528-1167.2008.01954.x
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/35637
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Neurology (신경과학)
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