Information for Healthcare Providers
DIACOMIT® (stiripentol) is an effective, FDA-approved medication that was developed specifically to treat seizures associated with Dravet syndrome. It is indicated for patients 6 months and older (weighing 15 lb or more) taking clobazam. There are no clinical data to support the use of DIACOMIT as a monotherapy.1
Proven, Effective Seizure Relief
DIACOMIT is the only treatment specifically for seizures associated with Dravet syndrome in children as young as 6 months. It is indicated for patients 15 lb or more taking clobazam, and it is proven to significantly reduce generalized clonic or tonic-clonic seizures.1,2
Significant Results in Two Pivotal Trials
In two multicenter, randomized, double-blind, placebo-controlled trials, patients with Dravet syndrome on DIACOMIT experienced significantly fewer seizures than those on placebo. After two months on treatment, 58.1% of patients (n=31) saw a 75% or greater reduction in clonic or tonic-clonic seizures with 38.7% becoming seizure-free.1,2,16
STICLO Italy and STICLO France Pooled Results Primary Endpoint: Responder Rate
Response was defined as experiencing a greater than 50% decrease in the frequency of generalized clonic or tonic-clonic seizures, and statistical significance was measured with a Fisher Exact Test, generating a p value of p <0.0001.
Additional Endpoints
Median Seizure Frequency
DIACOMIT reduced clonic or tonic-clonic seizures by 84% compared with a 5.8% reduction on placebo after two months on treatment.6
Seizure Freedom
After two months of treatment, 38.7% of patients on DIACOMIT experienced no generalized clonic or tonic-clonic seizures compared with 0% on placebo.6
STICLO Study Descriptions
STICLO France and STICLO Italy were multicenter, randomized, double-blind, placebo-controlled trials that were conducted according to similar protocols and had comparable results.1,2 Patients were 3 to less than 18 years old; had a confirmed diagnosis of Dravet syndrome; had inadequately controlled seizures on clobazam and valproate; and suffered from four or more generalized clonic or tonic-clonic seizures per month, despite optimized therapy.
Response was defined as experiencing a greater than 50% decrease in the frequency of generalized clonic or tonic-clonic seizures during the treatment period compared with baseline.2,7 “Seizure-free” was defined as experiencing no generalized clonic or tonic-clonic seizures for the duration of the study.1,6 The baseline was one month on clobazam and valproate before patients entered the double-blind trial for two months on either DIACOMIT (50 mg/kg/day) or placebo.
Review the DIACOMIT Efficacy and Safety Guide
Save DIACOMIT’s proven results for future reference.
25+ years of worldwide clinical experience, extensive data collection, and analysis.7, 36, 37
In 2000, DIACOMIT was approved for compassionate use in the United States, and in 2018, it was granted FDA approval.9,10,15 You may recognize DIACOMIT by its generic name, stiripentol, since the treatment was referred to as stiripentol under the compassionate use program until the FDA granted its approval.1,5
DIACOMIT has more than 25 years of real-world use, providing a treatment option specifically for children with Dravet syndrome in 35 countries. As of 2022, in addition to the United States, DIACOMIT is approved in the European Union, Iceland, Norway, Liechtenstein, Japan, Switzerland, Australia, and Canada.9-15
DIACOMIT in the United States
Wirrell et al., 2013: U.S. Retrospective Study (2005-2012)
Researchers collected data from physicians using stiripentol to treat two or more patients with Dravet syndrome between March 2005 and 2012. Thirteen physicians provided data on 82 children. With stiripentol, the majority of patients experienced reduction in frequency of prolonged seizures, rescue medication use, and emergency room or hospital visits.39
In this study, patients on stiripentol and clobazam (n=35) experienced an 80% reduction in seizure frequency.39
Antiepileptic response to treatment was scored on a 5-point scale from marked reduction to marked worsening. Patients on stiripentol, clobazam, and valproate (n=48) experienced a 62% reduction in seizure frequency. Thirty-one patients (n=82) reported adverse events, which were most commonly sedation and reduced appetite.39
| OVERALL SEIZURE FREQUENCY | STP + CLB (n=35) | STP + CLB + VPA (n=48) |
|---|---|---|
| Marked reduction | 11 (31%) | 17 (35%) |
| Mild reduction | 17 (49%) | 13 (27%) |
| No change | 7 (20%) | 16 (33%) |
| Mild worsening | 0 (0%) | 2 (4%) |
| Marked worsening | 0 (0%) | 0 (0%) |
| STP + CLB (n=35) | |
|---|---|
|
Marked reduction |
11 (31%) |
|
Mild reduction |
17 (49%) |
|
No change |
7 (20%) |
|
Mild worsening |
0 (0%) |
|
Marked worsening |
0 (0%) |
| STP + CLB + VPA (n=48) | |
|
Marked reduction |
17 (35%) |
|
Mild reduction |
13 (27%) |
|
No Change |
16 (33%) |
|
Mild worsening |
2 (4%) |
|
Marked worsening |
0 (0%) |
STP = stiripentol; CLB = clobazam; VPA = valproate
Wirrell et al. Study Description
Wirrell et al., 2013 was a retrospective chart review of 82 Dravet syndrome patients across 13 U.S. epilepsy reference centers between March 2005 and 2012. Participating physicians provided data for patients treated with stiripentol anytime in the three years before study onset (median age of initiation: 6.9 years). Data collected included stiripentol dosage, concomitant antiseizure medications, overall seizure frequency, prolonged seizures frequency, rescue medication use, emergency room visits in the year before and during treatment, and adverse effects treatment (reported in 38% of patients; primarily sedation and reduced appetite).39
Study Limitations
The study had limitations including that retrospective chart review is less accurate than prospective counts; patients were on varied other comedications, and their dose changes were not formally assessed; and adverse events were based on chart review, which may have limited reporting of milder side effects.