PMID- 21775167
OWN - NLM
STAT- MEDLINE
DCOM- 20120730
LR  - 20151119
IS  - 1532-2688 (Electronic)
IS  - 1059-1311 (Linking)
VI  - 20
IP  - 9
DP  - 2011 Nov
TI  - An open-label, add-on study of pregabalin in patients with partial seizures: a 
      multicenter trial in Greece.
PG  - 701-5
LID - 10.1016/j.seizure.2011.06.022 [doi]
AB  - INTRODUCTION: Pregabalin efficacy and safety as an adjunctive treatment for 
      partial seizures was evaluated using an open-label, flexible-dose. STUDY DESIGN: 
      In 98 adults with refractory partial epilepsy taking 1-3 anti-epileptic drugs 
      with >/=2 seizures during an 8-week baseline period. METHODS: Pregabalin was 
      increased to </=600 mg/day during a 9-week dose optimization period with dosage 
      maintained for 12 additional weeks. Primary endpoint was the percentage change in 
      partial seizure frequency between the 8-week baseline and 12-week observation 
      period. RESULTS: Pregabalin treatment was associated with a significant reduction 
      in partial seizure frequency: median percent change in partial seizure frequency 
      from baseline to 12 weeks was -33% and -22% in patients with a baseline seizure 
      frequency of </=3 and >3 per 28 days, respectively. The 50% and 75% responder rates 
      were 41.94% (95% CI: 31.91-51.96) and 30.11% (95% CI: 20.78-39.43), respectively. 
      Nineteen percent of subjects were seizure-free throughout the last 12 weeks. 
      Pregabalin administration resulted in a significant reduction in anxiety (mean 
      reduction in Hospital Anxiety and Depression Scale scores of 1.68 units, 95% CI: 
      -2.60 to -0.76). Most patients were much improved or very much improved on 
      Patient Global Impression of Change (53.8%) and Clinical Global Impression of 
      Change (53.8%). The most frequently self-reported adverse events (AEs) were mild 
      or moderate somnolence (20.4%) and dizziness (5.1%) with a low AE discontinuation 
      rate (5.1%). CONCLUSIONS: The efficacy and side-effect profile of pregabalin were 
      similar to previous pregabalin double-blind, controlled studies. Additionally, 
      pregabalin, as an add-on treatment for partial epilepsy, exhibits significant 
      anti-anxiety properties.
CI  - Copyright (c) 2011 British Epilepsy Association. Published by Elsevier Ltd. All 
      rights reserved.
FAU - Tsounis, Stefanos
AU  - Tsounis S
AD  - B'Department of Neurology, Aristotle University of Thessaloniki, AHEPA Hospital, 
      Thessaloniki, Greece. stet@med.auth.gr
FAU - Kimiskidis, Vasilios K
AU  - Kimiskidis VK
FAU - Kazis, Dimitrios
AU  - Kazis D
FAU - Gkiatas, Konstantinos
AU  - Gkiatas K
FAU - Garganis, Kyriakos
AU  - Garganis K
FAU - Karageorgiou, Klimentini
AU  - Karageorgiou K
FAU - Giannakodimos, Stylianos
AU  - Giannakodimos S
FAU - Papathanasopoulos, Panagiotis
AU  - Papathanasopoulos P
FAU - Plaitakis, Andreas
AU  - Plaitakis A
FAU - Papadimitriou, Alexandros
AU  - Papadimitriou A
FAU - Lyras, Leonidas
AU  - Lyras L
FAU - Emir, Birol
AU  - Emir B
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20110719
PL  - England
TA  - Seizure
JT  - Seizure
JID - 9306979
RN  - 0 (Adjuvants, Pharmaceutic)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
MH  - Adjuvants, Pharmaceutic/adverse effects/therapeutic use
MH  - Adolescent
MH  - Adult
MH  - Drug Administration Schedule
MH  - Epilepsies, Partial/*drug therapy/*epidemiology
MH  - Female
MH  - Greece/epidemiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pregabalin
MH  - Treatment Outcome
MH  - Young Adult
MH  - gamma-Aminobutyric Acid/adverse effects/*analogs & derivatives/therapeutic use
EDAT- 2011/07/22 06:00
MHDA- 2012/07/31 06:00
CRDT- 2011/07/22 06:00
PHST- 2010/11/02 00:00 [received]
PHST- 2011/06/28 00:00 [revised]
PHST- 2011/06/29 00:00 [accepted]
PHST- 2011/07/22 06:00 [entrez]
PHST- 2011/07/22 06:00 [pubmed]
PHST- 2012/07/31 06:00 [medline]
AID - S1059-1311(11)00181-6 [pii]
AID - 10.1016/j.seizure.2011.06.022 [doi]
PST - ppublish
SO  - Seizure. 2011 Nov;20(9):701-5. doi: 10.1016/j.seizure.2011.06.022. Epub 2011 Jul 
      19.