Outcomes research: Clinical trials in the elderly

• Published in: Epilepsy research Vol. 68; pp. 71 - 76
• Main Authors: Leppik, Ilo E., Brodie, Martin J., Saetre, Erik R., Rowan, A. James, Ramsay, R. Eugene, Jacobs, Margaret P.
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Amsterdam Elsevier B.V 2006; Elsevier
• Subjects: Aged; Anticonvulsants - therapeutic use; Anticonvulsants. Antiepileptics. Antiparkinson agents; Antiepileptic drugs; Biological and medical sciences; Clinical trials; Elderly; Epilepsy; Epilepsy - drug therapy; Human viral diseases; Humans; Infectious diseases; Medical sciences; Multicenter Studies as Topic; Neuropharmacology; Pharmacology. Drug treatments; Randomized Controlled Trials as Topic - statistics & numerical data; Treatment Outcome; Veterans - statistics & numerical data; Viral diseases; Viral diseases of the nervous system; United States; North America; America; Clinical trials; Elderly; Antiepileptic drugs; Epilepsy; Human; Nervous system diseases; Prognosis; Gabapentin; Anticonvulsant; Tricyclic compound; Carbamazepine; Cerebral disorder; Analgesic; Treatment; Mood stabilizer; Central nervous system disease; Triazine derivatives; Risk factor; Dibenzazepine derivatives; Lamotrigine
• ISSN: 0920-1211; 1872-6844
• DOI: 10.1016/j.eplepsyres.2005.07.019

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.