Pregabalin Evaluated in Pediatric Patients With Partial Onset Seizures
According to results of a study presented at the AES Annual Meeting 2017, a larger percentage of patients experienced a decrease in partial onset seizure (POS) frequency and POS subtypes when administered 2.5mg/kg and 10mg/kg of pregabalin daily vs placebo.
Data from a previously reported double-blind, placebo-controlled, international study was utilized to determine the efficacy of pregabalin in subtypes of POS. A total of 295 patients aged 4–16 years who experienced POS despite treatment with 1–3 antiepileptic medications were included in the analysis. Patients were either administered 2.5mg/kg of pregabalin daily (max 150mg/day; n=104), 10mg/kg of pregabalin daily (max 600 mg/day; n=97), or placebo (n=94).
Of the patients included in the study, 55% were male and 69% were white. The average age of patients in the study was 10.2 years. The authors reported, “For all POS and for most POS subtypes, pregabalin resulted in a numerically greater percentage of subjects who exhibited categorical decreases in seizure frequency vs placebo.” More consistent decreases in percentages were observed in patients in the pregabalin 10mg/kg/day group vs patients in the pregabalin 2.5mg/kg/day group.
The study also found that a small percentage of participants experienced an increase of ≥25% in seizure frequency; 15.1% of placebo patients compared to 7.8% of patients in the pregabalin 2.5mg/kg/day group and 11.5% of patients in the pregabalin 10mg/kg/day group. The study authors added that “relatively few” patients in any treatment group were seizure-free (decrease of 100%). Pregabalin was well-tolerated among patients according to analyses of adverse events, laboratory measures, vital signs, ECG data, and additional safety measurements.
Pregabalin was found to be both safe as well as effective in the treatment of POS in pediatric patients. The authors stated, “In general, no POS subtype appeared less responsive or non-responsive to pregabalin vs placebo, including complex POS and POS that secondarily generalize which may have greater concerns for morbidity.”
Antinew J. et al. Efficacy of pregabalin in pediatric epilepsy patients: Analysis of partial onset sizure subtypes in a randomized controlled trial. Presented at AES annual meeting in Washington, DC. Abstract: 3.265.