S-Space College of Medicine/School of Medicine (의과대학/대학원) Dept. of Neurology (신경과학교실) Journal Papers (저널논문_신경과학교실)
Pregabalin add-on therapy using a flexible, optimized dose schedule in refractory partial epilepsies: A double-blind, randomized, placebo-controlled, multicenter trial
- Lee, Byung In; Yi, Sangdoe; Hong, Seung Bong; Kim, Myeong-Kyu; Lee, Sang Kun; Kim, Jae Moon; Heo, Kyoung; Leon, Teresa; Lowe, Wing; Song, Hong Ki; Shin, Dong-Jin; Lee, Sang Ahm
- Issue Date
- WILEY-BLACKWELL PUBLISHING, INC
- EPILEPSIA; Vol.50 3; 464-474
- 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 (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 (>= 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 <= 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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