Early treatment may benefit with Dravet syndrome, study shows

Fintepla (fenfluramine) — either alone or as an add-on to Diacomit (stiripentol) — was associated with fewer seizures in a small group of young patients with Dravet syndrome, a study from Italy found. The results also suggested that starting treatment earlier may offer cognitive and motor benefits.

“These associations were substantially influenced by age, disease duration, and treatment era,” the researchers wrote. The study, “Efficacy of stiripentol, fenfluramine, and their combination on clinical outcomes in Dravet syndrome: A preliminary report,” was published in Epilepsia Open.

Dravet syndrome is caused when mutations in the SCN1A gene, or more rarely in other genes, result in abnormal electrical activity in the brain. This can cause Dravet symptoms including repeated, prolonged seizures that usually begin within the first year of life. It can also cause a range of problems with behavior, cognition, and movement.

Fintepla is approved to treat seizures in patients aged 2 and older with Dravet syndrome or Lennox-Gastaut syndrome, another type of epilepsy. It works by prompting nerve cells to release serotonin, a signaling molecule that helps the cells communicate with neighboring cells in the brain. Although the exact mechanism is unclear, this is expected to reduce seizures.

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Comparing treatments

There is limited real-world evidence comparing Fintepla with other anti-seizure medications, such as Diacomit, or studying their combined use. To help collect evidence, the researchers reviewed the medical records of 66 patients who were diagnosed with Dravet syndrome at a median age of 18.4 months. About two-thirds (63.6%) began experiencing seizures within the first six months of life.

At the last follow-up, 29 patients were taking Fintepla, 15 were taking Diacomit, seven were taking both, and 15 were taking other anti-seizure medicines. Treatment groups changed over time, because some patients switched medications when treatment was not effective enough or caused side effects. The groups were not randomly assigned and were not necessarily similar.

Even so, at the last follow-up, the frequency of seizures occurring daily, weekly, monthly, or sporadically differed among treatment groups. Patients taking Fintepla — either alone or as an add-on to Diacomit — generally had less frequent seizures than patients receiving other anti-seizure medications. This difference remained significant after accounting for age and disease duration.

Problems with movement also appeared to differ between treatment groups in the initial analysis. However, this difference diminished after accounting for age and disease duration. There were no significant differences between treatment groups in cognitive outcomes or neuropsychiatric diseases after these adjustments.

Among patients taking Diacomit alone, earlier treatment was associated with better cognitive outcomes and less frequent movement and neuropsychiatric problems. For those taking Fintepla, earlier treatment was also associated with better cognitive outcomes and less frequent movement problems.

However, the findings do not prove that starting treatment earlier yielded greater benefits. When the researchers considered factors such as age, disease duration, and follow-up time, many of these associations became weaker or even disappeared. There were also no significant differences by type of disease-causing genetic mutation.

Patients who had previously received an anti-seizure medication not recommended for Dravet had a higher frequency of status epilepticus (a prolonged seizure or repeated seizures without full recovery between them). The researchers also observed that older patients tended to have more severe symptoms. However, older patients had generally started Fintepla or Diacomit at older ages.

While the study included a small number of patients, it suggests that treatment with Fintepla was associated with less frequent seizures at the last follow-up. Earlier treatment was also associated with some benefits, but these associations were affected by other factors.

“While disease severity appeared to increase with age and long-term disability remains common, the extent to which treatment timing may independently influence long-term outcomes cannot be determined,” the researchers wrote. “Larger prospective studies are needed to determine whether earlier treatment independently influences long-term developmental outcomes.”