WEDNESDAY, May 1, 2019 (Pharmacist's Briefing) -- For patients with Dravet syndrome (DS) and drug-resistant seizures, cannabidiol (CBD) is associated with a reduction in seizures, according to a study scheduled to be presented at the annual meeting of the American Academy of Neurology, held from May 4 to 10 in Philadelphia.
Ian Miller, M.D., of Miami Children's Hospital, and colleagues examined the efficacy and safety of two doses of CBD as add-on anticonvulsant therapy for patients with DS and drug-resistant seizures. One hundred ninety-nine patients (mean age, 9 years) were randomly assigned to CBD at 20 mg/kg/day (CBD20; 67 patients), 10 mg/kg/day (CBD10; 67 patients), or placebo (65 patients). The change in convulsive seizure frequency was measured during the 14-week treatment period.
The researchers found that compared with placebo, CBD20 and CBD10 groups had higher percentage reductions in convulsive seizures (46 and 49 percent, respectively, versus 27 percent), higher ≥50 percent responder rates (49 and 44 percent, respectively, versus 26 percent), and higher percentage reductions in total seizures (47 and 56 percent, respectively, versus 30 percent). All groups had a similar incidence of adverse events (90, 88, and 89 percent, respectively). Serious adverse events were reported in 25, 20, and 15 percent of patients, respectively. Only the CBD20 group had any patients discontinue use due to adverse events (7 percent).
"Based on these results, dose increases above 10 mg/kg per day should be carefully considered based on the effectiveness and safety for each individual," Miller said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including GW Research, developer of cannabidiol, which funded the study.