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Year : 2020  |  Volume : 68  |  Issue : 6  |  Page : 1400--1408

Adjunctive Brivaracetam in Indian Patients with Uncontrolled Focal Epilepsy: Results from a Pooled Analysis of Two Double-Blind, Randomized, Placebo-Controlled Trials

1 MS Ramaiah Medical College, Bengaluru, Karnataka, India
2 National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India
3 Poona Hospital, Pune, Maharashtra, India
4 Neurocare, Nashik, Maharashtra, India
5 Krishna Institute of Medical Sciences, Hyderabad, Telangana, India
6 SMS Hospital, Jaipur, Rajasthan, India
7 King George Medical University, Lucknow, Uttar Pradesh, India
8 Jaslok Hospital, Mumbai, Maharashtra, India
9 KEM Hospital, Pune, Maharashtra, India
10 Apollo Hospital, Madurai, Tamil Nadu, India
11 KEM Hospital, Mumbai, Maharashtra, India
12 Hinduja Hospital, Mumbai, Maharashtra, India
13 UCB Pharma, India
14 UCB Pharma, Raleigh, NC, USA

Correspondence Address:
Dr. Sanjib Sinha
National Institute of Mental Health and Neurosciences Hosur Rd, Near Bangalore Milk Dairy, Lakkasandra, Laljinagar, Wilson Garden, Bengaluru, Karnataka 560029
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0028-3886.304103

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Background: Nearly one-third of patients don't achieve seizure control with existing antiepileptic drugs. Brivaracetam (BRV) is a new member of the racetam class of drug, designed to selectively target SV2A, with binding affinity 15- to 30-fold greater than that of levetiracetam. Objective: This pooled analysis reports efficacy and tolerability data of adjunct BRV (50, 100, and 200 mg/day) compared with placebo in Indian patients with uncontrolled focal epilepsy. Methods: Data of 104 patients (aged 16–80 years) from 2 studies (N01252 and N01358) were pooled for this analysis. The studies comprised an 8-week prospective baseline period, and a 12-week treatment period. The study endpoints included median percent reduction from baseline in focal seizure frequency/28-days, ≥50% responder rate, and seizure freedom (all seizure types). The safety analysis included treatment-emergent adverse events (TEAEs). Results: The efficacy population comprised 101 patients. In the Indian sub-group population, median percent reduction from baseline in focal seizure frequency/28-days was greater in the BRV dose groups: 39.7% (p = 0.00868), 46.8% (p = 0.00180) and 48.2% (p = 0.05224), for BRV 50, 100, 200 mg/day, respectively, compared with 20.6% for placebo. Responder rates (≥50%) were 38.1%, 45.7%, and 45.5% for BRV 50, 100, and 200 mg/day, respectively, compared with 11.7% for placebo. Complete seizure freedom was reported by 4.8% (1/21) and 2.9% (1/35) of patients on BRV50 and 100 mg/day, respectively, and none out of the 11 and 34 patients on BRV200 mg/day and placebo, respectively. In the safety population (n = 104), most commonly reported TEAEs (reported by ≥5% of patients taking brivaracetam) were headache and cough; most TEAEs were mild or moderate in intensity. Conclusion: This pooled analysis has provided evidence that adjunct brivaracetam, was effective and well-tolerated in Indian patients with uncontrolled focal epilepsy.


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