title: Impact of seizure frequency reduction on health-related quality of life among clinical trial subjects with refractory partial-onset seizures: A pooled analysis of phase III clinical trials of eslicarbazepine acetate.
abstract: Subjects who received eslicarbazepine acetate (ESL) as adjunctive therapy experienced significantly greater seizure frequency reduction (SFR) than placebo in three phase III, randomized, double-blind trials. This analysis compared changes in health-related quality of life (HRQOL) between treatment responders and non-responders across the pooled, per-protocol population (N=842) using the validated Quality of Life in Epilepsy Inventory-31 (QOLIE-31).
  
  
  
  QOLIE-31 scores were calculated for Total Score (TS) and seven subscales; higher scores indicate better HRQOL. Mean changes from baseline were calculated. Analysis of covariance examined least square mean (LSM) differences in final scores between responders (≥50% and ≥75% SFR) and non-responders. Clinical significance was based on established minimal clinically important differences (MCIDs).
  
  
  
  Mean changes were greater among responders for TS (5.2 versus 1.4 for ≥50% SFR; 7.5 versus 1.9 for ≥75% SFR) and all subscales. Additionally, the percentage of subjects with changes meeting or exceeding MCIDs was higher among responders for TS (48.4% versus 33.9% for ≥50% SFR; 56.9% versus 35.8% for ≥75% SFR) and all subscales. Responders had significantly higher final scores for TS (LSM difference=4.0 for ≥50% SFR; LSM difference=5.7 for ≥75% SFR) and all subscales except emotional well-being at ≥50% SFR. LSM differences exceeded MCIDs at ≥75% SFR for TS and five of seven subscales, and two subscales at ≥50% SFR. In a subgroup analysis with placebo removed, LSM differences were larger overall.
  
  
  
  In clinical trials of adjunctive ESL, higher levels of SFR were associated with greater improvements in HRQOL.
authors.affiliation: Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States. Electronic address: Fulton.Velez@sunovion.com.
authors.forename: Fulton F
authors.initials: FF
authors.lastname: Velez
authors.affiliation: Covance Market Access Services Inc., 9801 Washingtonian Blvd., 9th Floor, Gaithersburg, MD 20878, United States. Electronic address: Christopher.Bond@covance.com.
authors.forename: T Christopher
authors.initials: TC
authors.lastname: Bond
authors.affiliation: Covance Market Access Services Inc., 9801 Washingtonian Blvd., 9th Floor, Gaithersburg, MD 20878, United States. Electronic address: Kathryn.Anastassopoulos@covance.com.
authors.forename: Kathryn P
authors.initials: KP
authors.lastname: Anastassopoulos
authors.affiliation: Covance Market Access Services Inc., 9801 Washingtonian Blvd., 9th Floor, Gaithersburg, MD 20878, United States. Electronic address: Xuezhe.Wang@Covance.com.
authors.forename: Xuezhe
authors.initials: X
authors.lastname: Wang
authors.affiliation: Bial, Department of Research and Development, À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal. Electronic address: Rui.Sousa@bial.com.
authors.forename: Rui
authors.initials: R
authors.lastname: Sousa
authors.affiliation: Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States. Electronic address: David.Blum@sunovion.com.
authors.forename: David
authors.initials: D
authors.lastname: Blum
authors.affiliation: Independent consultant, 2207 Bancroft St., Houston, TX 77027, United States. Electronic address: joyce.cramer@gmail.com.
authors.forename: Joyce A
authors.initials: JA
authors.lastname: Cramer
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D003984:Dibenzazepines / Q000627:therapeutic use*; D004311:Double-Blind Method; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D011788:Quality of Life; D012640:Seizures / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D003984:Dibenzazepines; C416835:eslicarbazepine acetate
keywords: Epilepsy; Eslicarbazepine acetate; Health-related quality of life; Minimal clinically important difference; Partial-onset seizures; QOLIE-31