Efficacy and safety of Dibufelon in drug-resistant epilepsy

SUMMARY. Improving the efficiency of diagnosis and treatment of drug-resistant epilepsy is an urgent problem of modern neurology and neurosurgery.

PURPOSE OF THE STUDY: to evaluate the efficacy and safety of Dibufelon in drug-resistant epilepsy, at a dose of 800 mg per day (analysis of data from a clinical study and clinical cases).

MATERIALS AND METHODS. The analysis included data from 9 patients. Of these, 4 took part in a clinical study according to Protocol No.: DBF‑01/10: “Multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy, safety and tolerability of Dibufelon® as adjuvant therapy in patients with partial epileptic seizures. This study was carried out at the RNHI them. A.L. Polenov in 2012–2014. In addition, the data of 5 patients who took Dibufelon after the official registration of the drug and its entry into the pharmaceutical market were taken into account.

RESULTS. 4 patients were participants in a phase III clinical trial according to Protocol No.: DBF‑01/10 (Dibufelon). In another 5 patients, the experience of using Dibufelon was assessed as part of routine practice, after registration of the drug. All patients were regularly taking the study drug at the prescribed dosage. There were no changes in the basic therapy for epilepsy. All patients taking Dibufelon noted its good tolerance, there were no adverse events. The dynamics showed a decrease in the frequency of seizures, an increase in the duration of remission (the absence of epileptic seizures) and an improvement in cognitive functions. In all patients taking Dibufelon, the EEG showed a trend towards positive changes in bioelectrical activity over time. One of the patients noted an improvement in sexual function, which may indicate an improvement in the quality of life in patients with epilepsy while taking Dibufelon

CONCLUSION. The experience of using Dibufelon in the research center has shown its effectiveness and favorable tolerability profile in the adjunctive therapy of focal epileptic seizures in patients with various forms of structural epilepsy.

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