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 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.

Prevalence of anxiety disorders in patients with refractory focal epilepsy--a prospective clinic based survey.

Comorbid anxiety disorders severely affect daily living and quality of life in patients with epilepsy. We evaluated 97 consecutive outpatients (41.2% male, mean age=42.3+/-13.2 years, mean epilepsy duration=26.9+/-14.2 years) with refractory focal epilepsy using the German version of the anxiety section of the Structured Clinical Interview for DSM-IV Axis I disorders (SCID-I). Nineteen patients (19.6%) were diagnosed with an anxiety disorder (social phobia, 7.2%; specific phobia, 6.2%; panic disorder, 5.1%; generalized anxiety disorder, 3.1%; anxiety disorder not further specified, 2.1%; obsessive-compulsive disorder, 1.0%; posttraumatic stress disorder, 1.0%). Four-week prevalence rates reported elsewhere for the general population in Germany are 1.24% for social phobia, 4.8% for specific phobia, 1.1% for panic disorder, 1.2% for generalized anxiety disorder, 1.3% for anxiety disorder not further specified, and 0.4% for obsessive-compulsive disorder. A trend for people with shorter epilepsy duration (P=0.084) and younger age (P=0.078) being more likely to have a diagnosis of anxiety disorder was revealed. No gender differences were found; however, this may be due to the small sample size. In conclusion, anxiety disorders are frequent in patients with refractory focal epilepsy, and clinicians should carefully examine their patients with this important comorbidity in mind.

Retention rate of pregabalin in drug-resistant epilepsy: 1-year follow-up, single-centre observation in 105 consecutive, adult patients.

OBJECTIVES: Pregabalin (PGB) is a newer antiepileptic drug (AED) licensed as add-on treatment for partial epilepsy in adults. Efficacy and safety have been proven in several controlled clinical studies. These trials, however, only partially reflect clinical practice. Retention rate has been established as a marker for efficacy and safety of AEDs in long-term follow-up studies. METHODS: We evaluated the data of the first 105 patients treated with PGB at Bethel Epilepsy Centre, a tertiary referral centre for epilepsy. The patients were interviewed after 3, 6 and 12 months. RESULTS: 105 adult patients (aged 38+/-13 years) were treated with PGB, on average in combination with 2.1 AEDs (mean observation period 232 days). 76.2% had focal epilepsy, 19.0 multifocal epilepsy, and 3.8% epilepsy with both focal and generalised seizures. 40% continued PGB with the following outcome: 5.7% seizure-free for at least 1 month (4.8% for at least 3 months, 2.4% for at least 6 months; one of the seizure-free patients, however, had had epilepsy surgery during the observational period), 17.1% responders (> or =50% reduction of seizure frequency but not seizure-free), 13.3% with unchanged or increased seizure frequency. Reasons for withdrawal were lack of efficacy (47.6%) or side-effects (12.7%). CONCLUSIONS: PGB is a new therapeutic option as add-on therapy for patients with highly refractory focal epilepsies although the therapeutic success that can be expected in this group of patients is limited.