Safety and Tolerability of Oxcarbazepine in Elderly Patients
Abstract number :
3.121
Submission category :
Year :
2001
Submission ID :
2898
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
E. Kutluay, MD, Neurology, University of Michigan, Ann Arbor, MI; E.A. Passaro, MD, Neurology, University of Michigan, Ann Arbor, MI; C.J. Milling, MD, Neurology, University of Michigan, Ann Arbor, MI; J. D[ssquote]Souza, PhD, Department of Central Nervou
RATIONALE: Oxcarbazepine (OXC), a keto-analog of carbamazepine, is approved for monotherapy and adjunctive therapy in adults and as adjunctive therapy in children with seizures of partial onset. The aim of this study is to evaluate the safety and tolerability of OXC in the elderly population.
METHODS: We reviewed the database of all patients with exposure to OXC in randomized epilepsy clinical trials to identify patients 65 years and older. We reviewed the duration of exposure, adverse events profile, discontinuations due to adverse events and laboratory abnormalities in that group and compared them to patients in the 18 to 64 years age group. Comparison between groups was done with the Chi Square test with levels of significance set at P values [lt] 0.05.
RESULTS: Out of a total of 1626 patients with epilepsy 18 years and older, 52 (31 women, 21 men) patients were 65 years and older and 1574 patients were in the 18-64 years age group. 64% of elderly patients were exposed to OXC for more than 3 months compared to 69% in the younger age group. The most common adverse events experienced by elderly patients were vomiting (19%), dizziness (17%), nausea (17%) and somnolence (15%) compared to headache (32%), dizziness (29%), somnolence (24%) and nausea (20%) in the younger group. Headache, diplopia and viral infection were significantly more frequent in the younger age group. There was no significant difference in the discontinuation rate due to adverse events between the two groups, with 14 patients (27%) and 341 patients (22%) dropping out from the elderly and younger age groups respectively. The majority of adverse events leading to withdrawal were related to the nervous and digestive systems. There was no significant difference between the two groups in serum chemistry except for sodium. The mean decrease in serum sodium levels was more prominent in the elderly group (range 4.2 to 8.8 mmol/L) compared to the younger group (range 1.4 to 2.8 mmol/L). There was no death related to OXC in the elderly group.
CONCLUSIONS: Those results indicate that OXC is safe and generally well tolerated in the elderly population with epilepsy. Hyponatremia tends to be more common in this age group, suggesting that a closer monitoring of sodium levels in this age group might be needed, especially if on concomitant natriuretic medications
Support: Novartis
Disclosure: Salary - Novartis (D[ssquote]Souza); Grant - Novartis; Stock - Novartis (D[ssquote]Souza); Honoraria - Novartis