Efficacy and safety of pregabalin in refractory focal epilepsy with and without comorbid anxiety disorders — Results of an open-label, parallel group, investigator-initiated, proof-of-concept study

•Anxiety disorders are prevalent in people with epilepsy.•They severely influence daily living and quality of life.•Pregabalin is effective in improving seizure frequency and anxiety symptoms.•Reduction of seizure frequency is more marked in patients with epilepsy plus anxiety.

Anxiety disorders are prevalent in people with epilepsy and severely influence daily living and quality of life. Pregabalin (PGB) is licensed in Germany for the add on-treatment of focal epilepsy and for generalized anxiety disorder in adults. To our knowledge, PGB has not been studied before in patients with epilepsy and comorbid anxiety disorder.We included 41 adult patients with focal epilepsy in a monocentric, noncontrolled open-label study adding up to 600 mg of PGB to an antiepileptic baseline medication. Patients were allocated to two groups: patients with epilepsy plus anxiety disorder (EAG) and patients with epilepsy only (EOG). Endpoints were responder rate, seizure frequency, adverse events, and anxiety symptoms.The responder rate in the EAG was higher compared to that in the EOG (per protocol population: 9 [75.0%] vs. 2 [12.5%], p = 0.001). Improvements in several psychological scales were found.