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Cannabidiol (Epidyolex°) in epilepsy associated with tuberous sclerosis complex

Cannabidiol, a substance present in cannabis, has antiepileptic properties. Having already been authorised in the European Union for children with certain severe forms of epilepsy, it has now also been authorised for use in patients aged 2 years and older who have epileptic seizures associated with tuberous sclerosis complex.

  • Tuberous sclerosis complex is a rare genetic disease. Beginning in infancy, benign tumours develop in a wide range of organs including the brain, kidneys, skin, eyes, liver and lungs. Many patients start having epileptic seizures before 1 year of age.
  • In one placebo-controlled trial in 151 patients, addition of cannabidiol to antiepileptic treatment reduced the median number of seizures per month (26 versus 40 in the placebo group), at a cost of increased serious adverse effects.
  • In practice, cannabidiol provides an alternative option to everolimus for the difficult clinical situation in which a patient continues to have seizures despite antiepileptic treatment.

©Prescrire 1 November 2022

Source: "Cannabidiol (Epidyolex°) in epilepsy associated with tuberous sclerosis complex" Prescrire International 2022; 31 (242): 264-265. Subscribers only.

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See also:

"Cannabidiol - Epidyolex°.
In certain severe forms of
childhood epilepsy: an option
to consider, but liver function
must be monitored"
Prescrire Int 2020;
29 (218): 205-207.
Pdf, subscribers only

"Everolimus for epilepsy
associated with tuberous
sclerosis complex. Primarily
for patients with very
troublesome partial seizures"
Prescrire Int 2018;
27 (199): 288-289.
Pdf, subscribers only

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