Real-World Approaches to Cannabinoids in Pediatric-Onset Epilepsy: What Do the Data Tell Us? CME, Anup Patel, WWW.medscape.org, 2019

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22 décembre 2019 GRECC 0

Real-World Approaches to Cannabinoids in Pediatric-Onset Epilepsy: What Do the Data Tell Us? CME

Anup Patel, MD

Posted: 12/19/2019

https://www.medscape.org/viewarticle/922715

 

Educational Impact Challenge

The goal of this activity is to improve knowledge and competence related to the selection of cannabinoid-based therapies for pediatric-onset seizure disorders.

Before you begin this activity, please assess your clinical knowledge by completing this brief survey. Answering these questions again after the activity will allow you to see what you learned and to compare your answers with those of your peers.

What did you learn from this activity? Please click on the “Next” button to proceed to a brief survey to see how your knowledge improved after the education. You can also see how your answers compare with those of your peers.

Question 1 of 4

Pharmaceutical-grade cannabidiol oral solution (CBD-OS) has been studied in 2 randomized controlled trials (RCTs) in Lennox-Gastaut syndrome (LGS) and 2 RCTs in Dravet syndrome.

What is the highest dose of pharmaceutical-grade CBD-OS reported to be tested in these phase 3 RCTs for seizures associated with LGS or Dravet syndrome?

5 mg/kg/d

10 mg/kg/d

15 mg/kg/d

20 mg/kg/d

25 mg/kg/d

Question 2 of 4

After engaging in shared decision making with the parents of Sarah, your 12-year-old patient with Dravet syndrome, you have together decided to add pharmaceutical-grade CBD-OS at 5 mg/kg/d to Sarah’s antiseizure drug (ASD) regimen.

If Sarah is taking which of the following drugs would you caution her parents to be particularly vigilant about increased sedation?

Brivaracetam

Clobazam

Lacosimide

Valproate

Question 3 of 4

Ian is a 9-year-old boy with LGS. He has intellectual disability, uses a wheelchair, requires assistance with all activities of daily living, and has daily tonic-clonic seizures that are not controlled with his current 3-drug antiseizure regimen. Four previously tried ASDs also failed to control his seizures. His parents would like to try a “natural” treatment and have informed you that they have purchased a bottle of CBD oil online (artisanal CBD) and would like to add it to Ian’s ASD regimen.

Which of the following treatments are you most likely to recommend to the parents?

Artisanal CBD oil because it does not cause adverse effects, nor is there any concern about drug-drug interaction with Ian’s other medications

Artisanal CBD oil because each batch of a brand of artisanal CBD oil is manufactured in the same manner and therefore a specific dosing can be recommended

Pharmaceutical-grade CBD-OS because it has FDA approval for the treatment of seizures associated with LGS

Off-label pharmaceutical-grade CBD-OS even though it has FDA approval only for seizures associated with Dravet syndrome and tuberous sclerosis complex

Question 4 of 4

How confident are you right now in prescribing pharmaceutical-grade CBD-OS for your patients with seizures? (Select ranking from 1 [Not confident] to 5 [Very confident])

1 – Not confident

2 – Slightly confident

3 – Moderately confident

4 – Mostly confident

5 – Very confident

AE = adverse event
AED = antiepilepsy drug
ANA = antinuclear antibodies
ASD = antiseizure drug
CBD-OS = cannabidiol oral solution
CI = confidence interval
CLB = clobazam
COX = cyclooxygenase
DEA = Drug Enforcement Administration
DS = Dravet syndrome
EAP = expanded access program
FIRES = febrile infection-related epilepsy syndrome
5-HT = 5-hydroxytryptamine
GABA = gamma-aminobutyric acid
ILAE = International League Against Epilepsy
LGS = Lennox-Gastaut syndrome
LTD = leading to discontinuation
MR = mental retardation
N-CLB = N-desmethylclobazam
NDA = New Drug Application
NO = nitric oxide
NSAID = nonsteroidal anti-inflammatory drug
PBO = placebo
PK = pharmacokinetics
RCT = randomized controlled trial
THC = tetrahydrocannabinol
THCA = tetrahydrocannabinolic acid
TNF = tumor necrosis factor
TRE = treatment-resistant epilepsy
TSC = tuberous sclerosis complex
ULN = upper limit of normal

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