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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
Author(s) -
Lee Byung In,
Yi Sangdoe,
Hong Seung Bong,
Kim MyeongKyu,
Lee Sang Ahm,
Lee Sang Kun,
Shin DongJin,
Kim Jae Moon,
Song Hong Ki,
Heo Kyoung,
Lowe Wing,
Leon Teresa
Publication year - 2009
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1167.2008.01954.x
Subject(s) - medicine , placebo , adverse effect , refractory (planetary science) , pregabalin , randomized controlled trial , population , confidence interval , anesthesia , dosing , post hoc analysis , pharmacotherapy , physics , alternative medicine , environmental health , pathology , astrobiology
Summary 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.