Introduction

Open-label and phase III studies on brivaracetam have shown good efficacy and high retention rates in focal-onset and genetic generalized epilepsies. However, there is a lack of evidence from real-life clinical practice. 

Aim

To evaluate the efficacy and tolerability of brivaracetam in patients with epilepsy in everyday clinical practice.

Patient Profile

• 156 epilepsy patients (>16 years of age) receiving brivaracetam and having at least one follow up encounter after dose titration

Method

Study Design

• Retrospective, observational, multicenter, post-marketing study

Endpoints

• Responsiveness
• Tolerability

  Results

  Efficacy

• Brivaracetam initiation achieved a rate of >50% responders in 71% patients, which included seizure cessation in 36% patients, at the first follow up visit (Figure 1)
• In a subgroup of patients with drug-resistant epilepsy, brivaracetam initiation treatment scored the >50% response rate in 62% patients, including 22% patients who achieved seizure freedom
• In patients switched from levetiracetam, brivaracetam achieved >50% response rate in 79%, including 30% patients who became seizure free

• The mean dose of brivaracetam intake was 172 mg and the dose range was 50–300 mg.
• No significant difference was noted in the effect on seizure frequency between two different brivaracetam dosing groups (50-150 mg vs. 200-300 mg)
• No significant difference was recorded in the effectiveness of brivaracetam treatment regarding focal or generalized epilepsy syndrome

Figure 1: Seizure frequency percentage change after brivaracetam treatment

Safety 

• Clinically significant adverse events (AE) seen in 17% (most frequent events were somnolence in 4% and fatigue in 4%), but none were life threatening
• Sixteen patients discontinued brivaracetam after the first follow up due to lack of efficacy, AEs or both
• In patients switched to brivaracetam from levetiracetam, 12% patients suffered from AEs with 5% of them displaying behavioral AE (irritation and anxiety); most common AEs were dizziness (5%) and somnolence (5%)

Conclusion

Brivaracetam effectively achieved seizure control and good safety profile in everyday clinical practice in epilepsy patients.

Pharmaceuticals 2021, 14, 165.