News Release

Study finds elderly patients achieve seizure freedom on epilepsy therapy

Peer-Reviewed Publication

American Epilepsy Society

CLEVELAND, Ohio and BOSTON – December 9, 2003 – According to the results of a study presented today, University Hospitals of Cleveland researchers found that treatment with the anti-epileptic drug (AED) Keppra (levetiracetam) used alone resulted in seizure freedom in elderly patients. In the study, more than 70 percent of patients who switched from their current AED therapies to treatment with Keppra alone became seizure-free and reported improved function after starting the medication. The results were presented at the American Epilepsy Society annual meeting, being held this week in Boston.

"Elderly patients are often on multiple medications, which can cause drug interactions that affect their quality of life," said Mary Ann Werz, M.D., Ph.D., director, Comprehensive Epilepsy Program, University Hospitals of Cleveland and lead investigator of the study. "It's remarkable that when patients were taken off their current medications, treatment with Keppra alone diminished their seizures and actually improved cognition, even in patients who had been suffering from epilepsy for almost 30 years."

Patients in the study took a median number of three medications for a variety of health conditions other than epilepsy, increasing the likelihood for potentially harmful drug interactions with seizure medications these patients might have been taking. Whereas most AEDs undergo metabolism in the liver, Keppra is cleared only by the kidneys and is not affected by other drugs.

Keppra is approved by the Food and Drug Administration for the adjunctive treatment of partial onset seizures in adults with epilepsy.

Study Design and Results

The study examined twenty patients between the ages of 61 and 88 (median age 76) treated with Keppra at the University Hospitals of Cleveland at Case Western Reserve University.

Age of onset and type and frequency of seizures were logged. Results of EEG, MRI, prior drug trials and the reason given for initiating Keppra were recorded. While being treated with Keppra, concomitant AEDs, adverse events, Keppra discontinuation, Keppra serum concentrations and serum creatinine were charted. Dosing ranged from 500 mg/day to 4,000 mg/day.

Seven chronic patients were converted to Keppra monotherapy to attempt to improve cognition and gait. Five have been seizure-free for five to 17 months on doses of 500 to 1,000 mg/day. These patients reported clear improvement in functional status. One patient had no change in seizure frequency and one discontinued treatment.

Four patients had newly identified epilepsy with Keppra as their first treatment and have been receiving total daily doses of 500 to 1,000 mg for eight to 11 months. The only adverse event in the trial was a seizure in one patient at the lower dose but none to date on 1,000 mg/day. Two were diagnosed within six months of first seizure and received a prior AED. One could not tolerate extended release carbamazepine in terms of cognition or gait. She has received 1,000 mg/day of Keppra in monotherapy without further seizures or significant side effects. The other patient had recent onset of seizures and a history of chronic anxiety and has not been able to tolerate any drug.

Seven chronic patients not on monotherapy received Keppra for treatment-resistant seizures. One patient has been seizure-free, one saw a greater than 75 percent decrease in seizures, two have had no change in seizure frequency and one had an increase in seizure frequency. The remaining two patients discontinued treatment.

Two patients with recent-onset seizures started Keppra as their second or third-line AED. One patient saw a greater than 75 percent decrease in seizures and the other discontinued treatment.

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About University Hospitals Health System

University Hospitals Health System (UHHS) is the region's premier healthcare delivery system, serving patients at more than 150 locations throughout northern Ohio. The System's 947-bed, tertiary medical center, University Hospitals of Cleveland (UHC), is the primary affiliate of Case Western Reserve University (CWRU). Together, they form the largest center for biomedical research in the State of Ohio. The System provides the major clinical base for translational researchers at the Case Research Institute, a partnership between UHC and CWRU School of Medicine, as well as a broad and well-characterized patient population for clinical trials involving the most advanced treatments. Included in UHC are Rainbow Babies & Children's Hospital, among the nation's best children's hospitals; Ireland Cancer Center, northern Ohio's only National Cancer Institute-designated Comprehensive Cancer Center (the nation's highest designation); and MacDonald Women's Hospital, Ohio's only hospital for women. Committed to advanced care and advanced caring, University Hospitals Health System offers the region's largest network of primary care physicians, outpatient centers and hospitals. The System also includes a network of specialty care physicians, skilled nursing, elder health, rehabilitation and home care services, managed care and insurance programs, and the most comprehensive behavioral health services in the region.

Case Western Reserve University is one of the nation's leading independent research universities, with programs that encompass the arts and sciences, engineering, the health sciences, law, management, and social work.

The University enrolls approximately 9,400 students-39 percent in undergraduate programs and the balance in graduate and professional programs. Among the University's nearly 1,300 international students are representatives of 90 nations. Domestic students represent all 50 states and the District of Columbia.

Case Western Reserve University's full-time faculty numbers over 2,200, supplemented by part-time and voluntary faculty. In addition to teaching, faculty engage in research and scholarship in their disciplines. This activity takes the form of more than 2,000 sponsored research and training projects, plus a large number of unsponsored projects. The University operates nearly 100 designated research centers and laboratories, many of them interdisciplinary in nature, in addition to its more traditional departmental research facilities.

Case Western Reserve University is the only Ohio institution ranked in the top 50 national universities by U.S. News & World Report. Its School of Medicine ranks in the top 25 of 125 accredited medical schools, with a #8 ranking for its family medicine program, and the Case School of Engineering ranks in the top 50 of 185 graduate engineering programs, with a #7 ranking for the graduate biomedical engineering program. The undergraduate engineering program ranks 31st, with a #4 ranking for the undergraduate biomedical engineering program.


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