title: The short-term impact of adjunctive tiagabine on health-related quality of life.
abstract: Combinations of tiagabine (TGB), carbamazepine (CBZ), and phenytoin (PHT) were compared for their impact on health-related quality of life (HRQOL) and adverse effects related to treatment efficacy for people with frequent complex partial seizures. Two independent, randomized, double-blind clinical trials for efficacy and safety were conducted simultaneously with treatment groups: CBZ+PHT versus CBZ+TGB, and PHT+CBZ versus PHT+TGB. Treatment was initiated at week 0 and continued through week 16. HRQOL was evaluated with the QOLIE-89. Treatment success was defined as > or =50% reduction in complex partial seizures. Among patients who achieved a > or =50% reduction in seizures, addition of TGB to baseline PHT enhanced patient perceptions of attention/concentration (13%; p = 0.002), memory (17%; p = 0.042), and language subscales (22%; p = 0.004). Addition of CBZ to PHT led to positive change in the work/driving/social relations subscale (14%; p = 0.004). These improvements were significantly different only between visits, not between the two treatment groups. Seizure worry subscale scores showed improvement among all treatment groups and was probably related to participation in the clinical trial. These exploratory analyses suggest a possible early positive effect of TGB on patient-perceived cognitive domains using the QOLIE-89. These findings are limited by the small sample size and could be related to reduction in seizures.
authors.affiliation: Yale University School of Medicine, 950 Campbell Ave., West Haven, Connecticut 06516-2770, USA. joyce.cramer@yale.edu
authors.forename: J
authors.initials: J
authors.lastname: Cramer
authors.forename: J
authors.initials: J
authors.lastname: Ryan
authors.forename: J
authors.initials: J
authors.lastname: Chang
authors.forename: K
authors.initials: K
authors.lastname: Sommerville
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D002220:Carbamazepine / Q000627:therapeutic use; D004311:Double-Blind Method; D017029:Epilepsy, Complex Partial / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006304:Health Status; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests / Q000706:statistics & numerical data; D009557:Nipecotic Acids / Q000627:therapeutic use*; D010672:Phenytoin / Q000627:therapeutic use; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires; D000078308:Tiagabine; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D009557:Nipecotic Acids; D002220:Carbamazepine; D010672:Phenytoin; D000078308:Tiagabine