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Topiramate Well Tolerated With Minimal Cognitive Effects in Elderly Patients: Presented at AES

By Bonnie Darves

BOSTON, MA -- December 16, 2003 -- The anti-seizure drug topiramate, used primarily as adjunctive therapy in adults and children with poorly controlled seizures, is proving safe and effective with minimal side effects in elderly patients, according to a study presented here December 9^th at the American Epilepsy Society Annual Meeting.

Fully 65% of patients in the study were seizure-free after 12 weeks of treatment with topiramate, and few patients in the continuing study have reported impaired or altered cognition, said lead author Lauren Morgenroth, MD, of the VA Medical Center in Miami, Florida, United States. The findings from a 24-week double-blind trial involving 39 patients may eventually translate into greater use of topiramate (TPM) in that population, she added. The study will eventually enroll 80 patients.

Drug effects, especially on cognitive function, are a problematic and potentially dangerous issue with elderly patients with epilepsy -- which means clinicians must often balance efficacy with other factors when deciding which antiepileptic drug to prescribe and at which dose.

"We found that topiramate was well tolerated in this population -- and that the seizure-free rate was very high, at 65%," she said. "There have been nearly 100 elderly patients who have participated in double-blind topiramate studies, and there doesn't appear to be an increased adverse events [rate] in this population compared with younger adults."

Topiramate is indicated as adjunctive therapy for adults and children with partial onset seizures or primary generalised tonic-clonic seizures -- and in patients age 2 and older with seizures associated with LGS.

Study participants had a mean age of 68 years and a mean baseline seizure frequency of one seizure monthly. All had a confirmed diagnosis of epilepsy, reported more than two seizures in the previous 12 months and were taking an antiepileptic drug. Topiramate was started at 25 mg daily and patients were then randomised to either 50 mg or 200 mg daily, as the baseline antiepileptic agent was withdrawn. The dose was increased over the 12-week period to the maximally tolerated dose.

To date, 46% of participants remain in the study. Among those who have withdrawn, 21% discontinued because of inadequate seizure control and 13% because of adverse events, primarily somnolence, depression, dizziness and fatigue. Six patients complained of cognitive problems, Dr. Morgenroth said, and the types of problems reported have been widely varied. For example, she said, two patients reported language disorder and one reported confusion.

The researchers expect to have more detailed data in March 2004, she added, but they are optimistic about the early findings.

The study was supported by Ortho-McNeil Pharmaceutical.


[Study title: Topiramate Monotherapy: Interim Blinded Data From a Study in Elderly Patients. Abstract 2.270]

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