Author: Biocodex


Long information

What is it?

Diacomit is a medicine that contains the active substance stiripentol. It is available as capsules and sachets (250 and 500 mg). The sachets contain a powder that is used to make up an oral suspension (a liquid with solid particles in it).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Diacomit is an anti-epileptic medicine. It is used in children with a very rare type of epilepsy called ?severe myoclonic epilepsy in infancy? (SMEI), also known as Dravet?s syndrome. This type of epilepsy affects young children. Diacomit is used as an add-on to clobazam and valproate (other anti-epileptic medicines) to treat generalised tonic-clonic seizures (major fits, including loss of consciousness) when these are not adequately controlled with clobazam and valproate. Because the number of patients with SMEI is low, the disease is considered ?rare?, and Diacomit was designated as an ?orphan medicine? (a medicine used in rare diseases) on 5 December 2001. The medicine can only be obtained with a prescription.

How is it used?

Treatment with Diacomit should only be given under the supervision of a doctor who specialises in the diagnosis and management of epilepsy in infants and children (a paediatrician or paediatric neurologist). The normal dose is 50 mg per kilogram body weight, divided into two or three doses during the day. Treatment usually starts with a low dose, which is gradually increased to the recommended dose over three days. After starting Diacomit, the dose of clobazam may need to be reduced. The dose of valproate does not normally need to be adjusted.
The main studies of Diacomit were in children over three years of age. Decisions regarding the use of Diacomit in younger children should be made on a patient-by-patient basis: it can only be given to younger children if the diagnosis of SMEI has been confirmed.
Diacomit should be given at the same time as food, but not with dairy products, carbonated drinks, fruit juice, or food or drinks that contain caffeine or theophylline (a substance found in black and green tea, among other products).

How does it work?

The exact way in which stiripentol, the active substance in Diacomit, acts as an anti-epileptic medicine is not fully understood. It may act by increasing the activity of other anti-epileptic medicines by slowing down the rate at which they are broken down by the liver. It may also increase the levels of a

?neurotransmitter? called gamma-aminobutyric acid (GABA) in the gaps between nerve cells in the brain. Neurotransmitters are substances in the body that relay signals from a nerve cell to another cell.

How has it been studied?

The effects of Diacomit were first tested in experimental models before being studied in humans. The two main studies of Diacomit involved 65 children between three and 18 years of age. The studies compared the effectiveness of Diacomit capsules or sachets and placebo (a dummy treatment), when they were added to the children?s existing treatment with clobazam and valproate. The main measure of effectiveness was the number of patients who ?responded? to treatment. A patient was classified as a ?responder? if the number of seizures in the second month of treatment was at least 50% lower than the number in the month before treatment was started.

What benefits has it shown during the studies?

More patients responded to treatment with Diacomit than to placebo. In the first study, 71% of the patients taking Diacomit responded to treatment (15 out of 21), compared with 5% of the placebo group (1 out of 20). Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9). However, it is not clear whether this effect is due to Diacomit itself or to increased levels of the other anti-epileptic medicines.

What is the risk associated?

The most common side effects with Diacomit (seen in more than 1 in 10 patients) are anorexia (loss of appetite), weight loss, insomnia (difficulty sleeping), drowsiness, ataxia (inability to co-ordinate muscle movements), hypotonia (low muscle strength) and dystonia (muscle disorders). For the full list of all side effects reported with Diacomit, see the Package Leaflet.
Diacomit should not be used in people who may be hypersensitive (allergic) to stiripentol or to any of the other ingredients. It must not be used in patients who have had psychoses (a serious mental state with a distorted sense of reality) with attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations). Care must be taken when Diacomit is used at the same time as other medicines. See the Package Leaflet for the full list of these medicines.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Diacomit had shown its effectiveness in SMEI, albeit in studies that were limited and did not last as long as the Committee expected. It decided that Diacomit?s benefits are greater than its risks for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with SMEI (or Dravet?s syndrome) whose seizures are not adequately controlled with clobazam and valproate. The Committee recommended that Diacomit be given marketing authorisation. Diacomit has been given ?Conditional Approval?. This means that there is more evidence to come about the medicine. Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.

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