RESUMO
In an 8-week open-trial substitution study, 64 subjects with seizure disorders living at an ICF/MR were randomly assigned to either brand-named Depakene or generic Valproic Acid USP (Solvay) medication. After 4 weeks, they were switched to the other medication. Blood levels and seizures were monitored. The price of the generic Valproic Acid was less than one tenth the price of Depakene. Results show that subjects had no statistically significant changes in seizures or blood levels when the two treatment regimens were compared. These findings suggest that generic Valproic Acid USP (Solvay) may be successfully used in this population, resulting in substantial cost savings.
Assuntos
Anticonvulsivantes/uso terapêutico , Medicamentos Genéricos , Deficiência Intelectual/complicações , Convulsões/complicações , Convulsões/tratamento farmacológico , Ácido Valproico/uso terapêutico , Adolescente , Adulto , Idoso , Estudos Cross-Over , Humanos , Pessoa de Meia-IdadeRESUMO
This study was conducted to determine whether Depakene could be substituted for Depakote, which would represent a significant financial savings, without sacrificing symptom control or drug tolerance. Over an 8-week period of intensive monitoring, we changed 77 patients from Depakote to Depakene. Results showed no change in seizure control, no adverse upper gastrointestinal side effect, no weight change, no sleep disturbance, no change in aberrant behavior, and no change in appetite. Patients were less less lethargic on Depakene than on Depakote. However, there was some increase in diarrhea, of uncertain cause. Some changes in psychiatric symptoms were also noted. Overall, this drug change was well-tolerated.
