title: Safety and efficacy of two pregabalin regimens for add-on treatment of partial epilepsy.
abstract: 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.
authors.affiliation: University of Michigan Health System, 1500 E. Medical Center Dr., UH 1 B 300/0036, Ann Arbor, MI 48109-0036, USA. beydoun@umich.edu
authors.forename: A
authors.initials: A
authors.lastname: Beydoun
authors.forename: B M
authors.initials: BM
authors.lastname: Uthman
authors.forename: A R
authors.initials: AR
authors.lastname: Kugler
authors.forename: M J
authors.initials: MJ
authors.lastname: Greiner
authors.forename: L E
authors.initials: LE
authors.lastname: Knapp
authors.forename: E A
authors.initials: EA
authors.lastname: Garofalo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001259:Ataxia / Q000139:chemically induced; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069583:Pregabalin; D011446:Prospective Studies; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use
chemical_list: D000927:Anticonvulsants; D002121:Calcium Channel Blockers; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid