PMID- 20113339
OWN - NLM
STAT- MEDLINE
DCOM- 20110110
LR  - 20151119
IS  - 1468-1331 (Electronic)
IS  - 1351-5101 (Linking)
VI  - 17
IP  - 5
DP  - 2010 May
TI  - Pregabalin in partial seizures: a pragmatic 21-week, open-label study (PREPS).
PG  - 726-32
LID - 10.1111/j.1468-1331.2009.02916.x [doi]
AB  - 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.
FAU - Ryvlin, P
AU  - Ryvlin P
AD  - CTRS-INSERM IDEE, U821, Universite Claude Bernard Lyon 1 and Neurological 
      Hospital, Hospices Civils de Lyon, Lyon, France. ryvlin@cermep.fr
FAU - Kalviainen, R
AU  - Kalviainen R
FAU - Von Raison, F
AU  - Von Raison F
FAU - Giordano, S
AU  - Giordano S
FAU - Emir, B
AU  - Emir B
FAU - Chatamra, K
AU  - Chatamra K
LA  - eng
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100125
PL  - England
TA  - Eur J Neurol
JT  - European journal of neurology
JID - 9506311
RN  - 0 (Anticonvulsants)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
MH  - Adult
MH  - Anticonvulsants/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Epilepsies, Partial/*drug therapy
MH  - Europe
MH  - Female
MH  - Humans
MH  - Male
MH  - Pregabalin
MH  - Prospective Studies
MH  - Retrospective Studies
MH  - Time Factors
MH  - Treatment Outcome
MH  - gamma-Aminobutyric Acid/administration & dosage/adverse effects/*analogs & 
      derivatives
EDAT- 2010/02/02 06:00
MHDA- 2011/01/11 06:00
CRDT- 2010/02/02 06:00
PHST- 2010/02/02 06:00 [entrez]
PHST- 2010/02/02 06:00 [pubmed]
PHST- 2011/01/11 06:00 [medline]
AID - ENE2916 [pii]
AID - 10.1111/j.1468-1331.2009.02916.x [doi]
PST - ppublish
SO  - Eur J Neurol. 2010 May;17(5):726-32. doi: 10.1111/j.1468-1331.2009.02916.x. Epub 
      2010 Jan 25.