title: Outcomes research: clinical trials in the elderly.
abstract: Very few clinical trials have been done in the elderly. This report reviews results of two completed studies and describes one in progress. The largest published study was a United States Veterans Affairs Administration study in newly diagnosed patients with epilepsy. It compared carbamazepine to gabapentin and lamotrigine, and found that, although equivalent in efficacy, the newer antiepileptic drugs (AEDs) were better tolerated. This study also highlighted many of the difficulties in recruiting and retaining elderly patients in studies, the large number of comorbidities, and the problems of distinguishing seizures in the elderly from other symptoms. Another study of new-onset epilepsy suggested that a large percentage of elderly patients respond to initial AED therapy, but side effect profiles differ. More studies are needed to better define the risk/benefit relationships in elderly patients.
authors.affiliation: University of Minnesota, College of Pharmacy, 308 Harvard St. SE, Minneapolis, MN 55455, USA. leppi001@umn.edu
authors.forename: Ilo E
authors.initials: IE
authors.lastname: Leppik
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Brodie
authors.forename: Erik R
authors.initials: ER
authors.lastname: Saetre
authors.forename: A James
authors.initials: AJ
authors.lastname: Rowan
authors.forename: R Eugene
authors.initials: RE
authors.lastname: Ramsay
authors.forename: Flavia
authors.initials: F
authors.lastname: Macias
authors.forename: Margaret P
authors.initials: MP
authors.lastname: Jacobs
mesh_terms: D000368:Aged; D000927:Anticonvulsants / Q000627:therapeutic use*; D004827:Epilepsy / Q000188:drug therapy*; D006801:Humans; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D016896:Treatment Outcome; D014728:Veterans / Q000706:statistics & numerical data
chemical_list: D000927:Anticonvulsants