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

Autor:	R, Srinivasa, Sanjib, Sinha, Satishchandra, Parthasarthy, Sudhir, Kothari, Rahul, Baviskar, Sita, Jayalakshmi, Bhawana, Sharma, Ravindra K, Garg, Joy, Desai, Nandan, Yardi, Meenakshi Sundaram, Salvadeeswaran, Sangeeta, Ravat, Mohan, Das, Roop, Gursahani, Swaroop, Suresh, Alok, Rasal, Sami, Elmoufti
Rok vydání:	2020
Předmět:	Treatment Outcome Pharmaceutical Preparations Humans Anticonvulsants Drug Therapy Combination Epilepsies Partial Prospective Studies Pyrrolidinones Randomized Controlled Trials as Topic
Zdroj:	Neurology India. 68(6)
ISSN:	1998-4022
Popis:	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.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.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).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.This pooled analysis has provided evidence that adjunct brivaracetam, was effective and well-tolerated in Indian patients with uncontrolled focal epilepsy.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=pmid________::0779bb27268161693e08f8e6ce94dabb https://pubmed.ncbi.nlm.nih.gov/33342876 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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