June 7, 2023

Diacomit Safe and Effective as Add-On Therapy in Dravet Infants 

Article published by Dravet Syndrome News

Diacomit (stiripentol) was safe and clinically effective at reducing seizures when given to infants with Dravet syndrome, ages 2 or younger, according to a 30-year real world study. It also reduced emergency hospitalizations due to long-lasting seizures.

“This 30-year, real-world experience shows that initiating stiripentol before the age of 2 years is highly beneficial for patients with Dravet syndrome,” researchers wrote in “Initiating stiripentol before 2 years of age in patients with Dravet syndrome is safe and beneficial against status epilepticus,” which was published in Developmental Medicine & Child Neurology.

Long-lasting seizures and status epilepticus are hallmark symptoms of Dravet syndrome’s onset and usually begin in the first year of life. They remain at high risk of occurrence during infancy and middle childhood. The seizures are life-threatening and interfere with development, affecting “quality of life, medical needs,” and families’ economic well-being.

Treatments focus on reducing seizures frequency and duration, and helping prevent and manage status epilepticus. For infants younger than 2, therapies remain limited, however, mainly due to the low frequency of seizures and their severity.

Diacomit, an antiseizure medication marketed by Biocodex, is administered as an add-on therapy to children with Dravet, including infants. Data on its effectiveness in infants younger than 2 is scarce, however, and individual efficacy or safety data are “often incomplete or pooled with those from older children,” the researchers wrote.

In this study, French researchers retrospectively analyzed real-world data of Dravet patients who began Diacomit before they were 2 and were followed for 30 years (1991-2021). Data from 131 patients (59 women, 72 men) collected over four patient databases in France were analyzed.

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