[Real-life study with pharmaceutical cannabidiol in refractory epilepsy]

Abstract

Pharmaceutical-grade cannabidiol (CBD) is an alternative treatment for patients with drug-resistant epilepsy (DRE). In 2022, the Italian Hospital of Buenos Aires implemented a non-medical change (NMC) of treatment, replacing one commercial pharmaceutical-grade CBD product with another, the latter also being the initial option for new patients.

Our objective was to evaluate the clinical outcomes of the commercial product change in this population.

Methods: Retrospective cohort of DRE patients who either switched from one commercial pharmaceutical-grade CBD product to another or started treatment with the new product. The clinical response was evaluated by changes in seizure frequency, perception of change with the Patient Global Impression of Change (PGIC) scale, and safety considering discontinuation and/or the presence of adverse effects.

Results: Nineteen patients were included, 12 in the change group and 7 in the new start group (7 pediatric and 12 adults). One patient discontinued treatment due to lack of response. Among those who completed follow-up, 8 (44%) reduced seizure frequency, 6 (33%) showed no change, and 4 (22%) increased seizure frequency. According to the PGIC scale, 9 (50%) remained unchanged, 5 (28%) reported barely noticeable changes, and 4 (22%) reported improvement. Adverse events were mild and transient.

Conclusion: The new commercial pharmaceutical-grade CBD product is a safe and valid option both for substitution and initial treatment in patients with DRE. During the treatment period, patients perceived stability or improvement according to the PGIC scale.