Studies show Keppra(reg) reduces seizure frequency in patients with brain tumors

Main Category: Epilepsy
Article Date: 24 Apr 2005 - 0:00 PDT

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The anti-epileptic drug Keppra(reg) (levetiracetam) significantly reduced seizures and was well tolerated in patients with brain tumors, according to research presented at the 57th annual meeting of the American Academy of Neurology (AAN).1,2 The findings are important because patients with brain tumors often suffer from seizures, and the most frequently prescribed treatments have complications that often can be avoided with Keppra(reg) and other, newer anti-epileptic drugs (AEDs).

"An estimated 350,000 people in the U.S. have brain tumors3, and approximately 20 to 40 percent of them experience seizures4. Many AEDs traditionally prescribed interact with other medications, complicating their dosing and effectiveness," said Glen H. J. Stevens, D.O., Ph.D., a lead investigator of one of the studies and Head: Section Adult Neuro-Oncology, Cleveland Clinic Foundation Ohio. He and his research team chose to assess Keppra(reg) in the study because it has no known drug interactions. "Keppra(reg) produced more than a 50 percent reduction in seizure activity in 60 percent of the patients, and was well tolerated," he said"

In a similarly designed study, researchers from Ohio State University showed that, in patients with brain tumors who had a median of one seizure a week, Keppra(reg) (levetiracetam) reduced seizure frequency in most patients, with nearly 60 percent becoming seizure free over the treatment period.

"Keppra(reg) resulted in impressive reductions in seizure frequency and improvement in control among the patients in our study," said lead investigator Herbert B. Newton, M.D., F.A.A.N., professor and director, Division of Neuro-Oncology, Department of Neurology, Ohio State University

Dr. Newton explained that the older, "first-generation" AEDs have been used the most in treating seizures in patients with brain tumors. However, because these AEDs are metabolized in the liver, they interact with steroids and many chemotherapy agents, also processed in the liver, reducing their cancer-fighting effectiveness. Many newer, second-generation AEDs, are not metabolized in the liver and have fewer drug interactions. Keppra is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.

Studies and Findings

The Cleveland Clinic study was a retrospective review of medical charts from 278 patients with varying types of brain tumors who were treated with Keppra(reg) at the Clinic. Patients were evaluated for tumor type, seizure frequency, as well as side effects while on medication. Keppra(reg) produced a 50 percent reduction in seizure activity in 60 percent of patients. Additionally, 70 percent of patients were maintained on Keppra(reg) as monotherapy. A total of 10 patients (3.5 percent) stopped or reduced the dose of Keppra(reg) for behavioral-related side effects. Somnolence and fatigue were the most frequently reported adverse experiences. Dr. Newton presented retrospective findings on 41 patients with brain tumors given Keppra(reg) (median dose 1,500 mg/day) as either add-on or monotherapy for treating seizures. Before treatment, patients had a baseline median seizure frequency of one per week; after treatment with Keppra(reg), seizure frequency was reduced in 88 percent of patients (p < 0.0001), with 59 percent achieving complete seizure control. No serious adverse events were reported in either study. The most common side effect was somnolence.

About Epilepsy

Epilepsy is the most common neurological disorder, estimated to affect 50 million people worldwide5 and 2.5 million Americans.6 The disease can strike at any time, but has the highest incidence in individuals under age two and over 65. In the U.S., 181,000 new cases of epilepsy are diagnosed each year. Up to 80 percent of people with epilepsy can gain full or partial control of their seizures with treatments such as anti-epileptic drugs.7 Surgery, the ketogenic diet or an implanted device that delivers electrical stimulation to the brain are other treatment options. About Keppra(reg)

Keppra(reg) (levetiracetam) is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Keppra(reg) is available in 250, 500 and 750 mg tablets and a grape-flavored (100 mg/mL) oral solution for patients who prefer a solution or have difficulty swallowing tablets. Taken with or without food, the effective recommended starting dose of Keppra(reg) is 1,000 mg/day given twice daily (500 mg bid). Since its launch, Keppra(reg) has had more than 500,000 unique patient starts in the United States and is the most prescribed second-generation AED used in adults with epilepsy.8

Keppra(reg) use is associated with the occurrence of central nervous system adverse events, including somnolence and fatigue, coordination difficulties, and behavioral abnormalities as well as hematological abnormalities. Keppra(reg) dosing must be individualized according to renal function status. In well-controlled clinical studies, the most frequently reported adverse events associated with the use of Keppra(reg) in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness.

About UCB Pharma, Inc.

UCB Pharma, Inc., with U.S. headquarters in Smyrna, Ga, is the North American subsidiary of the global biopharma leader of UCB S.A. The pharmaceutical sector is dedicated to the development and commercialization of innovative pharmaceutical products for the treatment of neurological diseases, allergy/immunology and oncology. UCB S.A. has core businesses in pharmaceuticals and surface specialties, employs over 10,000 people globally, and operates in more than 100 countries. Worldwide headquarters is located in Brussels, Belgium.

References:

1 Stevens GHJ, Vogelbaum MA, Suh JH, Peereboom DM, Barnett GH. Levetiracetam Use in Brain Tumor Patients. Abstract P01.066. Poster presentation at: 57th Annual Meeting of the American Academy of Neurology (AAN), Miami Beach, Florida. April 9-16, 2005.

2 Newton HB, Goldlust S, Pearl D. Retrospective Analysis of Levetiracetam for the Treatment of Seizures in Brain Tumor Patients. Abstract P01.065. Poster presentation at: 57th Annual Meeting of the American Academy of Neurology (AAN), Miami Beach, Florida. April 9-16, 2005.

3 Davis FG, Kupelian V, Freels S, McCarthy B, Surawicz T. Prevalence Estimates for Primary Brain Tumors in the United States by Behavior and Major Histology Groups. Neuro-Oncology; 2001 Jul;3(3):152-8.

4 Glantz MJ, Cole BF, Forsyth PA, Recht LD, Wen PY, Chamberlain MC, Grossman SA, Cairncoss JG. Practice Parameter: Anticonvulsants Prophylaxis in Patients with Newly Diagnosed Brain Tumors - report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2000; 54: 1886-1893.

5 Scott RA, Lhatoo SD, Sander JWAS. Policy and Practice: The Treatment of Epilepsy in Developing Countries: Where Do We Go From Here? The World Health Organization Web site, available at: http://www.who.int/docstore/bulletin/pdf/2001/issue4/vol79.no.4.344-351.pdf. Accessed on March 31, 2005.

6 Epilepsy Foundation. Epilepsy and Seizure Statistics. Available at: http://www.epilepsyfoundation.org/answerplace/statistics.cfm. Accessed on March 31, 2005.

7 Epilepsy Foundation. Epilepsy: A Spectrum of Severity. Available at: http://www.epilepsyfoundation.org/answerplace/severity.cfm. Accessed on March 31, 2005.

8 Available from: Verispan Retail Pharmacy Database. Accessed May 2004.

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Lisa Garman
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Email: lisa.garman@ucb-group.com

Janene Ferrara
Chandler Chicco Agency
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