March 20, 2003
CHICAGO, IL and SMYRNA, GA
SOURCE: UCB Pharma, Inc.
Results from a new study showed that the antiepileptic drug Keppra® (levetiracetam), in combination with tricyclic antidepressants, anticonvulsant drugs and/or long-acting narcotics, provided some multiple sclerosis (MS) patients improvement in pain and uncomfortable sensations associated with their condition. The study of Keppra®, which is approved by the U.S. Food and Drug Administration for the adjunctive treatment of partial onset seizures in adults with epilepsy, was conducted at the MS Treatment and Research Center of the Yale School of Medicine and presented today at the American Pain Society's 22nd Annual Scientific Meeting.
MS affects more than 400,000 people in North America and about 2.5 million worldwide. Over 60 percent of MS patients experience moderate to severe pain, although less than 10 percent are on medication. Frequent syndromes encountered include painful limb spasms; deep, aching leg pain; a burning sensation and uncomfortable buzzing sensations derived from spinal cord involvement.
"We were interested in studying Keppra® in combination with more commonly used treatments for neuropathic pain and paresthesias in MS patients. Because of its unique mechanism of action, it can potentially complement other anticonvulsant treatments," said Marco Rizzo, M.D., Ph.D., author of the study and assistant professor at the Yale School of Medicine, New Haven, Conn. "We were impressed to find that Keppra® was well-tolerated and effective for neuropathic pain and uncomfortable numbness."
In this open-label study, Keppra® was given to 21 MS patients who continued to have disabling neuropathic symptoms despite more conventional treatments. More than half of the patients showed marked improvement and continue to be treated with Keppra®. In combination with tricyclic compounds, other anticonvulsants, and/or long-acting narcotics, the dose was titrated up to between 500 and 4,500 mg/day.
More than half (12 of 21) of patients exhibited moderate to marked improvement of symptoms as a result of the introduction of Keppra® therapy. Three of the 21 patients showed mild improvement; five showed no positive response and one patient discontinued at 500 mg/day due to fatigue and disorientation. Two of the 12 patients who showed moderate or marked symptom improvement were able to discontinue all other pain therapies after treatment for 4 to 8 months. A majority of the patients continue on adjunctive Keppra® treatment.
Adverse events that could not with confidence be correlated directly with Keppra® use included weakness, urinary retention, worsening spasticity and numbness.
Keppra® 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® 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 pharmaceutical sector of UCB S.A. The pharmaceutical 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 10,000 people globally in more than 100 countries. Worldwide headquarters are located in Brussels, Belgium.
For full prescribing information consult www.keppra.com.
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