Data analysis shows Keppra® reduced partial seizures in nearly 80 percent of elderly patients in a community-based trial.
ONOLULU and SMYRNA, Ga. - April 1, 2003 - Results of an analysis of elderly patients with epilepsy confirmed the efficacy and safety of Keppra(r) (levetiracetam) in a real-world, community setting. The analysis, presented today at the 55th Annual Meeting of the American Academy of Neurology, found Keppra(r) safely reduced partial seizure frequency by 80.1 percent in 78 participants, age 65 or over, in the Phase IV KEEPER trial, with 40 percent becoming seizure free.
An estimated 61,000 new cases of epilepsy occur each year among elderly Americans 1, many caused by such common conditions as stroke, heart attack and Alzheimer's disease 2. Ten percent of Americans will experience a seizure during their lifetime, and about three percent will have a diagnosis of epilepsy by age 75. Approximately 2.3 million Americans have epilepsy 1.
"Epilepsy in the elderly can be significantly disabling, as these patients are more fragile and more sensitive to the effects of medication," said Dr. James Ferrendelli, professor and chairman of neurology at the University of Texas-Houston Medical School and lead author of this study. "Elderly patients typically take multiple medications for other conditions, so identifying a treatment that works well with other medications and has no drug-drug interactions is critical to controlling seizures. Keppra(r) seems to be highly effective in the elderly population, with a low incidence of side effects."
A recent national survey found that more than 90 percent of people age 65 or older-not living in hospitals or institutions-used at least one medication per week, and more than 40 percent used five or more different medications every week 3.
The KEEPER trial was the first large-scale, community-based clinical trial of Keppra(r) to confirm the safety and efficacy seen in the clinical development program. Keppra(r) tablets are approved by the U.S. Food and Drug Administration as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Keppra(r) tablets are now available in 24 countries worldwide.
KEEPER was a Phase IV, prospective, open-label, multicenter, community-based trial of 1,030 patients that consisted of five office visits conducted over a 16-week treatment period. A four-week dose adjustment period was followed by a 12-week evaluation period.
The specific subpopulation (n=78) analyzed was of study participants age 65 or older who experienced three to 42 partial-onset seizures over the three months prior to study entry, despite a stable regimen (for at least four weeks preceding study entry) of at least one but no more than two AEDs.
The mean age of the subpopulation was 73.5 years, and included more females (61.5 percent) than males (38.5 percent). Monthly baseline seizure frequency was 3.3 seizures, and cause of epilepsy was most often unknown (57.7 percent). Patients were initiated with twice daily dosing of Keppra(r) as add-on therapy at 1,000 mg/day. Keppra(r) maximum daily dose was 1,000 mg in 52.6 percent, 2,000 mg in 20.5 percent and 3,000 mg in 19.2 percent of patients.
Keppra(r) efficacy was demonstrated by a median overall reduction in seizure frequency of 80.1 percent; 76.9 percent experienced a 50 percent or greater reduction in seizures; 56.9 percent had 75 percent or greater reduction in seizures; and 40.0 percent became seizure free during treatment. Global Evaluation Scale (GES) ratings indicated that 76.0 percent of patients showed marked, moderate or slight improvement.
Keppra(r) was well-tolerated in patients age 65 and older, with 42.3 percent reporting at least one treatment-related adverse event (AE). The most common side effects were somnolence (16.7 percent) and dizziness (9 percent). Of the 78 patients enrolled, 15 (19 percent) discontinued due to AEs.
Keppra(r) use is associated with the occurrence of central nervous system adverse events, including somnolence and fatigue, coordination difficulties, and behavioral abnormalities, and with minor, but statistically significant, hematological abnormalities. Keppra(r) dosing must be individualized according to renal function status.
UCB Pharma, Inc., with U.S. headquarters in Smyrna, Ga., is the North American subsidiary of the global, research-based Pharma Sector of UCB S.A. The Pharma Sector is dedicated to the development and commercialization of innovative pharmaceutical products for the treatment of neurological diseases and allergy-asthma. UCB S.A. has core businesses in pharmaceuticals and surface specialties, and employs over 12,000 people globally. Worldwide headquarters are located in Brussels, Belgium.
1http://www.efa.org/epusa/nation/nation.html#3 (accessed 2/27/03)
2http://www.epilepsyfoundation.org/answerplace/later/causes.html (accessed 3/3/03)
3Kaufman DW, Kelly JP, Rosenberg L, Anderson TE, Mitchell AA. Recent patterns of medication use in the ambulatory adult population of the United States: the Slone Survey. Journal of American Medical Association 2002; 287: 337-344.
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