Brivaracetam: review of its pharmacology and potential use as adjunctive therapy in patients with partial onset seizures

Figures & data

Table 1 Randomized controlled trials for BRV

Trial	Design (type of trial)	Number of patients treated with BRV	BRV range	Responder rates $50%	Median percent reductions from baseline in seizure frequency/week
French et al^Citation30	RCT double-blind vs placebo	154	5–50 mg/d	32.0% for BRV 5 mg/d	29.9% for BRV 5 mg/d
				44.2% for BRV 20 mg/d	42.6% for BRV 20 mg/d
				55.8% for BRV 50 mg/d	53.1% for BRV 50 mg/d
Van Paesschen et al^Citation31	RCT double-blind vs placebo	105	50–150 mg/d	35.8% for BRV 50 mg/d	34.9% for BRV 50 mg/d
				30.8% for BRV 150 mg/d	28.3% for BRV 150 mg/d
Ryvlin et al^Citation32	RCT double-blind vs placebo	298	20–100 mg/d	27.3% for BRV 20 mg/d	30.0% for BRV 20 mg/d
				27.3% for BRV 50 mg/d	26.8% for BRV 50 mg/d
				36.0% for BRV 100 mg/d	32.5% for BRV 100 mg/d
Biton et al^Citation33	RCT double-blind vs placebo	298	5–50 mg/d	21.9% for BRV 5 mg/d	20% for BRV 5 mg/d
				23.2% for BRV 20 mg/d	22.5% for BRV 20 mg/d
				32.7% for BRV 50 mg/d	30.5% for BRV 50 mg/d
Kwan et al^Citation35	RCT double-blind vs placebo	323	Flexible doses 20–150 mg/d	30.3% in BRV groups with partial seizures	26.9% in BRV groups with partial seizures
				44.4% in BRV group with	42.6% in BRV group with
				generalized seizures	generalized seizures
Klein et al^Citation34	RCT double-blind vs placebo	760	Fixed doses 100–200 mg/d	38.9% for BRV 100 mg/d	22.8% for BRV 100 mg/d
				37.8% for BRV 200 mg/d	23.2% for BRV 200 mg/d

Abbreviations: RCT, randomized clinical trials; BRV, brivaracetam.

Table 2 BRV adverse events observed during five clinical trials and their incidence

Adverse event	BRV (n=1,214)	Placebo (n=425)	P-value
Dizziness, n (%)	66/1,214 (5.4%)	18/425 (4.2%)	0.37
Fatigue, n (%)	84/1,214 (6.9%)	15/425 (3.5%)	0.01*
Headache, n (%)	141/1,214 (12%)	55/425 (13%)	0.48
Somnolence, n (%)	122/1,214 (10%)	25/425 (5.8%)	0.03*
Gastrointestinal symptoms (nausea, vomiting, diarrhea), n (%)	82/1,060 (7.7%)	28/371 (7.5%)	1.00

Notes:

* P<0.05 (significantly different from placebo group). Data were obtained from previously published data in clinical trials.^30–35

Abbreviation: BRV, brivaracetam.

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