Researchers Use the Simulations Plus DILIsym® Platform to Predict Safety of Combined CBD and VPA Treatment
CBD is an FDA-approved treatment for seizures in patients diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex.
- CBD is an FDA-approved treatment for seizures in patients diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex.
- During the pre-approval clinical trials, treatment with CBD was occasionally associated with elevation in blood levels of ALT, a marker of liver injury, but this was much more common in patients already receiving treatment with VPA for seizures.
- To identify potential underlying mechanisms, researchers used DILIsym to predict ALT levels in simulated populations that were treated with CBD alone, treated with VPA alone, and then treated with VPA before they were treated with CBD.
- DILIsym predicted dose-dependent ALT elevations for CBD treatment and ALT elevations for VPA treatment when each was given alone, but the combined VPA and CBD treatment protocol mimicking the clinical trials did not increase the incidence of ALT elevations relative to CBD treatment on its own.