PMID- 15699378
OWN - NLM
STAT- MEDLINE
DCOM- 20050919
LR  - 20151119
IS  - 1526-632X (Electronic)
IS  - 0028-3878 (Linking)
VI  - 64
IP  - 3
DP  - 2005 Feb 8
TI  - Safety and efficacy of two pregabalin regimens for add-on treatment of partial 
      epilepsy.
PG  - 475-80
AB  - OBJECTIVE: To evaluate the efficacy, tolerability, and safety of two pregabalin 
      regimens administered as adjunctive therapy to that of placebo in patients with 
      medically refractory partial epilepsy. METHODS: A multicenter, double-blind, 
      randomized, parallel-group, placebo-controlled trial was performed. Following a 
      prospective 8-week baseline phase, patients were randomized to 12 weeks of 
      double-blind treatment with placebo or pregabalin 600 mg/day administered twice 
      daily (BID) or three times daily (TID). Primary efficacy was measured as change 
      in seizure frequency from baseline of either pregabalin regimen compared with 
      placebo. Secondary efficacy comparisons included the proportion of patients 
      experiencing > or =50% reduction in seizure frequency (responder rate) and median 
      percentage change from baseline in seizure frequency. Safety/tolerability 
      assessments included adverse events (AEs), physical and neurologic examinations, 
      and clinical laboratory evaluation. Efficacy and safety analyses were performed 
      on the intent-to-treat (ITT) population. RESULTS: Pregabalin treatment resulted 
      in seizure frequency reductions: 53% for pregabalin TID (p < or = 0.0001) and 44% 
      for pregabalin BID (p < or = 0.0001) compared with a 1% increase for placebo. 
      Responder rates were 49% for pregabalin TID and 43% for pregabalin BID compared 
      with 9% for placebo (p < or = 0.001). Both pregabalin regimens were similar in 
      efficacy and tolerability. The most common AEs were dizziness, somnolence, and 
      ataxia. CONCLUSIONS: Pregabalin administered at 600 mg/day is safe, generally 
      well tolerated, and efficacious as adjunctive therapy for the treatment of 
      patients with partial seizures, with or without secondary generalizations. This 
      dose can be administered on a twice daily or three times daily schedule with 
      similar efficacy and tolerability results.
FAU - Beydoun, A
AU  - Beydoun A
AD  - University of Michigan Health System, 1500 E. Medical Center Dr., UH 1 B 
      300/0036, Ann Arbor, MI 48109-0036, USA. beydoun@umich.edu
FAU - Uthman, B M
AU  - Uthman BM
FAU - Kugler, A R
AU  - Kugler AR
FAU - Greiner, M J
AU  - Greiner MJ
FAU - Knapp, L E
AU  - Knapp LE
FAU - Garofalo, E A
AU  - Garofalo EA
CN  - Pregabalin 1008-009 Study Group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Neurology
JT  - Neurology
JID - 0401060
RN  - 0 (Anticonvulsants)
RN  - 0 (Calcium Channel Blockers)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
CIN - Epilepsy Curr. 2005 Nov-Dec;5(6):217-9. PMID: 16372054
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticonvulsants/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Ataxia/chemically induced
MH  - Calcium Channel Blockers/administration & dosage/adverse 
      effects/pharmacokinetics/therapeutic use
MH  - Dizziness/chemically induced
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Epilepsies, Partial/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pregabalin
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - gamma-Aminobutyric Acid/administration & dosage/adverse effects/*analogs & 
      derivatives/pharmacokinetics/therapeutic use
EDAT- 2005/02/09 09:00
MHDA- 2005/09/20 09:00
CRDT- 2005/02/09 09:00
PHST- 2005/02/09 09:00 [pubmed]
PHST- 2005/09/20 09:00 [medline]
PHST- 2005/02/09 09:00 [entrez]
AID - 64/3/475 [pii]
AID - 10.1212/01.WNL.0000150932.48688.BE [doi]
PST - ppublish
SO  - Neurology. 2005 Feb 8;64(3):475-80. doi: 10.1212/01.WNL.0000150932.48688.BE.