The Center recommends including vigabatrin in the form of granules for oral solution (500 mg) in the lists of medicinal products procured with state funds as monotherapy for infantile spasms (West syndrome) as first-line treatment – the conclusion from the state health technology assessment has been published.
Why is this important?
Infantile spasms (West syndrome) is a severe form of epilepsy that usually occurs in infants in the first months of life and manifests as series of short convulsive seizures and developmental delay. Without timely and effective treatment, the disease has an unfavourable prognosis: most children develop persistent developmental delay, and in a significant proportion of cases infantile spasms eventually progress to other, more severe forms of epilepsy.
What is the advantage of vigabatrin?
According to the results of a clinical study (Appleton et al., 1999), the use of vigabatrin in infants with infantile spasms was associated with cessation of epileptic spasms in the majority of patients in the vigabatrin group compared with placebo (35% versus 10%, respectively). In most patients who achieved cessation of spasms, resolution of hypsarrhythmia was also observed, indicating improvement in the functional state of the brain and a reduction in the risk of cognitive impairment.
In addition, a generally acceptable safety profile of vigabatrin was demonstrated provided clinical monitoring is carried out, which allows it to be considered an effective therapeutic option for the treatment of infantile spasms in conditions of limited alternatives.
Detailed information on the HTA conclusion regarding the medicinal product vigabatrin can be found on the website of the Center
It is worth noting that vigabatrin is already included in the list and is currently provided by the state payer in Ukraine, but only in tablet form. The inclusion of the granule formulation for oral solution will expand treatment options specifically for infants and young children, for whom the use of the tablet form is limited.
