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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.

 Byung In Lee  ;  Sangdoe Yi  ;  Seung Bong Hong  ;  Myeong-Kyu Kim  ;  Sang Ahm Lee  ;  Sang Kun Lee  ;  Dong-Jin Shin  ;  Jae Moon Kim  ;  Hong Ki Song  ;  Kyoung Heo  ;  Wing Lowe  ;  Teresa Leon 
 EPILEPSIA, Vol.50(3) : 464-474, 2009 
Journal Title
Issue Date
Adult ; Anticonvulsants/adverse effects ; Anticonvulsants/therapeutic use* ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug Therapy, Combination ; Epilepsies, Partial/drug therapy* ; Female ; Humans ; Korea ; Male ; Middle Aged ; Patient Satisfaction ; Pregabalin ; Treatment Outcome ; Young Adult ; gamma-Aminobutyric Acid/adverse effects ; gamma-Aminobutyric Acid/analogs & derivatives* ; gamma-Aminobutyric Acid/therapeutic use
Pregabalin ; Flexible‐dosing schedule ; Response ratio ; Add‐on therapy ; Tolerability
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 (>or=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. Seventy-seven 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 (>or=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 <or=20). DISCUSSION: PGB was effective and easily tolerable as add-on treatment in an Asian population with refractory partial-onset seizures
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1. College of Medicine (의과대학) > Dept. of Neurology (신경과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Byung In(이병인)
Heo, Kyoung(허경)
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