Drug updated on 12/11/2024
| Dosage Form | Capsule (oral; 250 mg, 500 mg); Suspension (oral; 250 mg, 500 mg) |
| Drug Class | Antiepileptics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more.
Latest News
Summary
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Reduction in Status Epilepticus (SE) Incidence: Stiripentol reduced SE episodes in 68% of patients with Dravet syndrome and developmental and epileptic encephalopathies (DEEs), achieving ≥50% reduction in episodes. 77% of patients became SE-free after stiripentol initiation.
- Reduction in Monthly Convulsive Seizure Frequency (MCSF (clinically meaningful)): Stiripentol (50 mg/kg/day) was effective in reducing MCSF by ≥50% and ≥75%, surpassing fenfluramine and cannabidiol in achieving seizure-free intervals. Stiripentol had the highest efficacy among add-on therapies for Dravet syndrome in reducing MCSF.
- Efficacy in Drug-Resistant Focal Epilepsy: No clear evidence was found for a ≥50% reduction in seizure frequency or seizure freedom with stiripentol compared to placebo in children with drug-resistant focal epilepsy.
- Stiripentol was generally well-tolerated, with no significant differences in serious adverse events (SAEs) compared to fenfluramine and cannabidiol, and a lower risk of discontinuations due to adverse events compared to both.
- In children with drug-resistant focal epilepsy, stiripentol showed a higher risk of neurological and gastrointestinal adverse effects compared to placebo, with wide confidence intervals indicating substantial variability.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Diacomit (stiripentol) Prescribing Information. | 2022 | Biocodex, Inc., Bedminster, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of stiripentol in the prevention and cessation of status epilepticus: A systematic review | 2024 | Epilepsia Open |
| Comparative efficacy and safety of stiripentol, cannabidiol and fenfluramine as first-line add-on therapies for seizures in Dravet syndrome: A network meta-analysis | 2024 | Epilepsia Open |
| Efficacy of pharmacological treatments for Dravet syndrome: Systematic review and network meta-analysis | 2024 | Seizure |
| Pharmacotherapy for Dravet Syndrome: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials | 2023 | Drugs |
| Efficacy and safety of adjunctive antiseizure medications for dravet syndrome: A systematic review and network meta-analysis | 2022 | Frontiers in Pharmacology |
| Stiripentol add-on therapy for drug-resistant focal epilepsy | 2022 | The Cochrane Database of Systematic Reviews |
| Stiripentol add-on therapy for drug-resistant focal epilepsy | 2020 | The Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| International consensus on diagnosis and management of Dravet syndrome | 2022 | Epilepsia |