TOLERABILITY OF LEVETIRACETAM IN ELDERLY PATIENTS WITH COGNITIVE DISORDERS, ANXIETY, AND EPILEPSY
Abstract number :
1.036
Submission category :
Year :
2003
Submission ID :
2235
Source :
www.aesnet.org
Presentation date :
12/6/2003 12:00:00 AM
Published date :
Dec 1, 2003, 06:00 AM
Authors :
Joyce A. Cramer, Katrien De Rue, Ilo E. Leppik, Guenter Kraemer Psychiatry, Yale University School of Medicine, West Haven, CT; UCB Pharma, Brussels, Belgium; MINCEP Epilepsy Care, Minneapolis, MN; Swiss Epilepsy Center, Zurich, Switzerland
The purpose of this analysis was to compare treatment-emergent adverse events (TEAE) related to use of levetiracetam (LEV) reported by young and elderly patients with cognitive disorders, anxiety, and epilepsy.
The LEV database includes reports of TEAE from placebo-controlled clinical trials from which patients were grouped as young ([lt]65 years) or elderly ([gt]65 years). Patient were diagnosed with a cognitive disorder (N=419 young, N=319 elderly), an anxiety disorder (N=1440 young, N=169 elderly), or localization-related epilepsy (N=1023 all young) who participated in trials lasting up to 16 weeks.
The most common TEAE occuring most frequently in the LEV treated groups were abdominal pain, asthenia, headache, anorexia, weight loss, dizziness insomnia, somnolence, and tremor. The only significant differences in TEAE were seen between young and elderly groups with anxiety disorders ([gt]3% higher for LEV than for placebo-treated patients) in headache (difference between LEV and Placebo: 5.2% elderly, -0.9% young, p=0.041), and tremor (5.2%, -0.5%, respectively, p=0.022) and between young anxiety patients and young epilepsy patients for somnolence (-0.7%, 5.4%, respectively, p=0.036). For the other TEAEs there was no evidence for consistent differences between young and elderly patients and between patients with different CNS disorders. The preponderance of adverse events was reported during the first four weeks of treatment for all groups. The proportion of LEV and placebo-treated patients discontinuing was low, exceeding 2% higher in LEV than placebo groups only for somnolence (all young LEV treated groups), dizziness (both elderly LEV treated groups), tremor (elderly LEV treated anxiety patients only) and asthenia (elderly LEV treated cognition group). Overall, elderly anxiety and young epilepsy patients had the highest incidences of TEAE, whereas those with cognitive disorders and young anxiety patients had the lowest incidences of TEAE. However, all of the epilepsy patients were receiving at least one other antiepileptic drug that may have contributed to this finding.
Overall, LEV was well tolerated by all patient groups. The favorable adverse event profile suggests that LEV might be suitable for use by elderly patients.
[Supported by: UCB Pharma]