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Diastat
 

Efficacy of Diastat

Two randomized, double-blind studies compared Diastat to placebo. The first study enrolled 91 patients (47 children, 44 adults), who received the first dose of Diastat at the onset of an identified seizure episode. Children were given a second dose four hours later whereas adults were dosed four and 12 hours after the first dose. The median seizure frequency for the Diastat treated group was zero seizures per hour, compared to a median seizure frequency of 0.3 seizures per hour for the placebo group (p < 0.0001). In addition, 62% of patients treated with Diastat were seizure-free during the observation period (12 hours for children, 24 hours for adults) compared to 20% of placebo patients.

The second study enrolled 114 patients (53 children, 61 adults). The dose was given at the onset of the identified episode. The median seizure frequency for the Diastat-treated group was zero seizures per 12 hours, compared to 2.0 seizures per 12 hours for the placebo group (p < 0.03). Patients treated with Diastat also had prolonged time-to-next-seizure compared to placebo (p = 0.0072).