COMPARATIVE EFFICACY AND SAFETY OF RUFINAMIDE AND VALPROIC ACID MONOTHERAPY IN EPILEPSY TREATMENT

Abstract

Background: It is a well-known fact that rufinamide and valproic acid (VPA) are antiepileptic drugs (AEDs) that are indicated for epilepsy, but there are limited data to show their relative efficacy and safety. This study evaluated and compared rufinamide against VPA as the monotherapy choice for the treatment of seizures. This challenge of identifying the right treatment for each patient with epilepsy makes it one of the most difficult types of neurological disorders to diagnose and correctly manage.

Methods: The 132 patients between 18-65 years of age with partial-onset seizures were randomized to two groups of which the first one (n=66) received rufinamide up to 400 mg twice daily while the second one (n=66) received extended-release VPA up to 1500 mg daily during the first 48 weeks period. The efficacy endpoints were seizure reduction by 28 days (at least 50% responders’ rate) and seizure freedom for at least 6 months, both associated with the quality of life. Safety and tolerability were the final important aspects as well.

Results: Taking 12-week treatment, rufinamide's marked median percent reduction in seizure frequency is much higher than VPA's (45.1 vs 33.4%; p<0.0001). While more subjects in the rufinamide group had ≥50% decrease in seizures (52.9% vs 33.6%, p<0.001), the latter still achieved significant outcomes. The consequences caused both grades of life scores to decrease. Adverse events often were similar, as were the discontinuations that occurred due to side effects with rufinamide (3.6% vs 4.4%).

Conclusions: The effectiveness that RUF and VPA have in terms of seizure control remains similar; however, Rufinamide monotherapy is more efficient, the tolerability being the same in both cases. In the case of Rufinamide, the effect is positive, and this medication is well-tolerated in epilepsy.